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MedWorm: Medical Devices News



MedWorm.com provides a medical RSS filtering service. Thousands of medical RSS feeds are combined and output via different filters. This feed contains the latest news in Medical Devices



Last Build Date: Fri, 23 Feb 2018 22:37:51 +0100

 



Medtronic Puts Insulin Needle Out of Sight, Out of Mind

Fri, 23 Feb 2018 21:08:39 +0100

Medtronic has launched the latest version of its MiniMed Mio insulin infusion set in Canada, Hong Kong and parts of Europe. The MiniMed Mio Advance is an update of the MiniMed Mio, introduced in 2010 and designed to deliver insulin from an insulin pump to the body. The Mio Advance should make changing infusion sets quicker and easier, according to the company. Diabetic patients who use insulin pumps generally change their infusion set every two or three days, selecting different insertion sites to prevent skin breakdown and maximize insulin absorption. Thin plastic tubing included in the set comes in varying lengths to reach different sites, such as the abdomen, thigh or buttock. The Mio Advance uses a concealed needle to insert a cannula -- a small, tapered tube at the end of the infusion...

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IDx Closer to Nod for Diabetic Retinopathy Diagnostic

Fri, 23 Feb 2018 20:55:27 +0100

Privately held IDx is developing an artificial intelligence-based system that could help with the diagnosis diabetic retinopathy – a disease that leads to blindness if undetected. The company met its endpoints in a pivotal trial of the IDx-DR system. The trial involved 900 diabetes patients at 10 sites. The study was designed to evaluate the diagnostic accuracy of the technology in detecting moderate to severe diabetic retinopathy, including macular edema. The results of the pivotal trial met the study hypotheses that were developed in consultation with FDA and demonstrated the IDx-DR system exceeded these performance goals. Network with your colleagues in medtech at ADM Cleveland, March 7–8, 2018.   The IDx-DR solution involves a small robotic camera that takes images of the eye. An...



India regulators flag hospitals for ‘ unethical profiteering ’ on devices

Fri, 23 Feb 2018 20:28:53 +0100

Indian regulators this week flagged the country’s hospitals for “unethical profiteering” from “exorbitant” markups – some as much as 2,000% – for commonly used medical devices. India’s National Pharmaceutical Pricing Authority – which has already slapped price caps on stents and other devices and is auditing alleged hospital overpricing on stenting procedures – cited the markups on syringes, cannulae and catheters. “The profit margins in the non-scheduled devices used in the three cases (syringes, cannula and catheters) are exorbitant and clearly a case of unethical profiteering in a failed market system,” the agency wrote in a Feb. 20 report, noting that “the major beneficiaries of profits in all these cases b...



Regulatory Challenges Top List of Concerns of Medtech Professionals

Fri, 23 Feb 2018 20:00:01 +0100

The survey of medtech professionals that regulatory consultancy Emergo (Austin, TX) conducts each year is a good gauge of the mood of the global medical device industry as it heads into a new year. Typically, there are no dramatic shifts in attitudes and perceptions from one year to the next—progress and change tend to be incremental in the medtech sector—but there is movement on the margins that can be instructive. From that perspective, key takeaways from the Global Medical Device Industry Outlook for 2018 include tempered growth expectations in all markets compared with 2017 and a broad consensus that a “changing regulatory environment” is the biggest challenge that industry faces in 2018. “Overall, it appears as though 2017 was more good than great,” writes Emergo Senior R...



Public Meeting - Pediatric Medical Device Development - August 13-14, 2018, FDA White Oak Campus https://go.usa.gov/xnerb   #FDA #MedicalDevice

Fri, 23 Feb 2018 18:07:36 +0100

Public Meeting - Pediatric Medical Device Development - August 13-14, 2018, FDA White Oak Campus https://go.usa.gov/xnerb  #FDA #MedicalDevice (Source: Food and Drug Adminstration (FDA): CDRHNew)



NICE backs irrigation device for constipation and incontinence

Fri, 23 Feb 2018 18:03:00 +0100

A medical device for treating constipation and faecal incontinence has been recommended for health service use by the National Institute for Health and Care Excellence. (Source: Nursing Times)

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5 Key Traits of the Medtech M & amp;A Landscape

Fri, 23 Feb 2018 16:45:40 +0100

As we've recently explored, mergers and acquisitions (M&As) continued to shape the landscape in the medical device and diagnostic industry in 2017.  We dug deep into the data to highlight five interesting trends found in M&A data from the past year in the infographic above. For a comprehensive list of companies that were bought, sold, or spun-off last year, download our free M&A report. The report includes the following information: buyers, sellers, value, deal type, deal status, payment type, and the data on which the deal was first announced. (Source: MDDI)



Integer shares jump on strong Q4 earnings beat

Fri, 23 Feb 2018 16:26:39 +0100

Integer Holdings (NYSE:ITGR) yesterday handily topped the consensus earnings expectation and met sales forecasts with its fourth-quarter and full-year results. The Frisco, Texas-based medical device contract manufacturer posted profits of $54.3 million, or $1.68 per share, on sales of $390.5 million for the three months ended Dec. 29, 2018, for a bottom-line gain of 585.0% on sales growth of 8.6% compared with Q4 2016. Integer said the profit surge was fueled by a $40 million benefit from the tax reforms enacted last year. Get the full story at our sister site, Medical Design & Outsourcing. The post Integer shares jump on strong Q4 earnings beat appeared first on MassDevice. (Source: Mass Device)



LVCM-019-016-02 Voice Coil Motor features stroke length of 0.25 in.

Fri, 23 Feb 2018 12:39:08 +0100

LVCM-019-016-02 Voice Coil Motor is suitable for testing, laser steering, mirror positioning, scanning, oscillations, dental or industrial applications. Unit produces continuous and peak force of 2.5 N and 7.8 N respectively. Having zero cogging and repeatability of less than 1μm, unit come in 19.1 mm diameter x 23.8 mm long envelope. Motor offers high force-to-size ratio.This story is related to the following:Health, Medical,& Dental Supplies and EquipmentSearch for suppliers of:Oscillating Motors (Source: Industrial Newsroom - Health, Medical and Dental Supplies)



AI Solution Detects Autism in Toddlers

Thu, 22 Feb 2018 22:20:38 +0100

A digital healthcare startup is using an artificial intelligence (AI) platform to help aid in the detection of autism. Palo Alto, CA -based Cognoa said FDA has classified the algorithm-powered solution as a Class II diagnostic medical device. The FDA designation gives the company a path to get full clearance as a medical diagnostic for autism. “The goal actually is this summer to submit to the FDA to get full clearance under a de novo as a medical diagnostic,” Sharief Taraman, vice president of medical at Cognoa, told MD+DI. “I think we should be able to get that at the end of the year or by 2019.” Network with your colleagues in medtech at ADM Cleveland, March 7–8, 2018.   The company said the average age of autism diagnosis is 4.1 years, which falls after the critical early...



Founding president of state's medtech lobbying group to step down

Thu, 22 Feb 2018 20:42:43 +0100

Tom Sommer, 62, told the Business Journal that he's planning to step down as the head of the statewide Massachusetts Medical Device Industry Council, or MassMEDIC, at the end of the year. (Source: bizjournals.com Health Care:Pharmaceuticals headlines)

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Endologix CEO: It & #039;s Time for a Leadership Change

Thu, 22 Feb 2018 19:56:08 +0100

It takes a strong leader to admit when his time is up. Endologix CEO John McDermott is that type of leader, which he proved this week with the announcement that he will be stepping down as CEO of the struggling endovascular aneurysm repair (EVAR) company. "The past couple of years have been difficult for the company, employees, and investors, so it's time for a leadership change," McDermott said during the company's fourth-quarter earnings call, according to Seeking Alpha transcripts. McDermott has been at the Irvine, CA-based company for nearly 10 years. He said he will continue in his role until the board hires his replacement. The company's revenue dropped 6.1% in the fiscal year 2017 compared to the fiscal year 2016. Last year the company discovered a manufacturing glitch during routi...



NN Inc. acquires medical device developer, manufacturer Bridgemedica

Thu, 22 Feb 2018 18:08:47 +0100

Diversified industrial company NN Inc. (Nasdaq: NNBR) announced today that it has completed its acquisition of Bridgemedica — which provides design, development engineering, manufacturing and packaging services to the medical device industry. Financial terms of the deal were not disclosed. Get the full story on our sister site Medical Design & Outsourcing.  The post NN Inc. acquires medical device developer, manufacturer Bridgemedica appeared first on MassDevice. (Source: Mass Device)



Report: India to allow stent makers to exit the market

Thu, 22 Feb 2018 18:03:11 +0100

Indian regulators reportedly said yesterday that it won’t force makers of drug-eluting stents to stay on the market there under its new price caps. Earlier this month India’s National Pharmaceutical Pricing Authority cut the prices on drug-eluting stents yet again, by about 7.6% from approximately $469.60 (₹30,180) to $433.82 (₹27,890). Those new price caps came as a surprise, as discussions earlier this month indicated NPPA’s willingness to revisit them, with many assuming the caps would increase. The NPPA capped prices for drug-eluting stents and bioresorbable scaffolds a year ago, slashing the prices for all coronary stents by as much as 85%. In early February this year Indian medical device makers and trade associations voiced their opposition to price caps on st...



Price control on stents to continue: Govt

Thu, 22 Feb 2018 17:05:29 +0100

Industry asked to be prepared to meet demand for medical devices, even as the Centre is laying grounds for the launch of its mega healthcare scheme. (Source: The Economic Times Healthcare and Biotech News)



Mark your calendars for #PatientEngagement in the National Evaluation System for Health Technology (NEST) one-day workshop sponsored by the UMD CERSI & FDA. Click the link for more info: https://goo.gl/CqZF4k   #NEST #MedicalDevice #safety

Thu, 22 Feb 2018 16:10:16 +0100

Mark your calendars for #PatientEngagement in the National Evaluation System for Health Technology (NEST) one-day workshop sponsored by the UMD CERSI & FDA. Click the link for more info: https://goo.gl/CqZF4k  #NEST #MedicalDevice #safety (Source: Food and Drug Adminstration (FDA): CDRHNew)

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Access Vascular Receives FDA Clearance For Its HydroPICC Catheter

Thu, 22 Feb 2018 15:44:32 +0100

The HydroPICC Uses Proprietary Technology Designed to Reduce Thrombosis BEDFORD, Mass., Feb. 22, 2018 -- (Healthcare Sales & Marketing Network) -- Access Vascular, a medical device company reinventing venous access using proprietary material technology... Devices, FDA Access Vascular, HydroPICC, peripherally inserted central catheter (Source: HSMN NewsFeed)



Novocure misses Q4 EPS by a penny, tops sales estimates

Thu, 22 Feb 2018 13:40:42 +0100

Shares in Novocure (NSDQ:NVCR) rose slightly today in premarket activity after the medical device maker met sales expectations, but missed earnings estimates on Wall Street with its fourth quarter and full-year financial results. The St. Helier, N.J.-based company reeled in losses this quarter, posting -$10.9 million on sales of $53.7 million for the 3 months ended Dec. 31, for sales growth of 78% compared with the same period last year. Get the full story at our sister site, Drug Delivery Business News. The post Novocure misses Q4 EPS by a penny, tops sales estimates appeared first on MassDevice. (Source: Mass Device)



FDA plans 2018 update for global UDI database

Thu, 22 Feb 2018 12:00:06 +0100

By Stewart Eisenhart, Emergo Group The US Food and Drug Administration will soon implement updates to its Global Unique Device Identification Database, or GUDID, based on feedback and requests from medical device manufacturers. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees. The post FDA plans 2018 update for global UDI database appeared first on MassDevice. (Source: Mass Device)



MicroPort < sup > ® < /sup > Signs Strategic Agreement with Wuhan Asian Industrial

Thu, 22 Feb 2018 10:17:52 +0100

(Source: Microport News Release)



Boston Sci Employee Found Guilty in Criminal Case

Wed, 21 Feb 2018 22:17:36 +0100

Boston Scientific faces $1 million in fines after an Italian court found one of its employees guilty in a criminal case, according to an SEC filing. On Feb. 23, 2015, the judge for the Court of Modena (Italy) ordered a trial for the Marlborough, MA-based company and three of its employees as well as numerous other defendants charged in criminal proceedings. Those charges arise from allegations that the defendants made improper donations to certain healthcare providers and other employees of the Hospital of Modena in order to induce them to conduct unauthorized clinical trials, as well as related government fraud in relation to the financing of such clinical trials, the company said. In its regulatory filing, Boston Scientific said on Dec. 1, 2015, the Brazilian governmental entity known a...

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German NnBU looks to fund newborn device dev with cryptocurrency offering

Wed, 21 Feb 2018 19:58:24 +0100

German medical device maker NnBU Holdings is looking to support the development of its device designed to improve outcomes for babies delivered by Caesarean-section through an unusual path – the company this week revealed plans to raise $18.5 million (EU €15 million) through an “Initial Coin Offering.” The NnBU device in development is designed to massage the torso of C-section newborns to stimulate the positive stresses of natural birth, and focuses light on the baby’s fontanel to create a “comfortable waking process for the newborn baby,” the company claims. The company said that conceptual design of the system has been completed. The NnBU baby care unit uses blockchain technology, the company said, and incorporates three functions into the blockchai...



FDA recognizes Cognoa's child development app as autism diagnostic

Wed, 21 Feb 2018 14:58:47 +0100

Palo Alto, California-based Cognoa ’s machine learning app for pediatric behavioral health has received categorization from the FDA as a Class 2 diagnostic medical device for autism, according to an announcement from the company. (Source: mobihealthnews)



Tandem Diabetes bids for Health Canada nod

Wed, 21 Feb 2018 14:16:19 +0100

Tandem Diabetes Care (NSDQ:TNDM) has submitted a medical device license application to Health Canada in the hopes of launching its t:slim X2 insulin pump in Canada in the second half of this year. The San Diego, Calif.-based company expects that its device will be able to display both English and French and will include a 24-hour clock. Get the full story at our sister site, Drug Delivery Business News. The post Tandem Diabetes bids for Health Canada nod appeared first on MassDevice. (Source: Mass Device)



Mitralign raises $10m

Wed, 21 Feb 2018 13:40:27 +0100

Mitralign, which is looking to commercialize its namesake mitral valve treatment and pursue regulatory nods for its Trialign tricuspid valve device, said it raised nearly $10 million. The $9.8 million funding, of a hoped-for $30.2 million, came from 19 unnamed investors beginning last September, the Tewksbury, Mass.-based company said in a regulatory filing. Mitralign raised a $40 million Series E round in May 2016. The Mitralign and Trialign devices are designed to use wire and catheters to implant polyester anchors within the annulus of the mitral and tricuspid valves. The anchors are then cinched together to reduce valve circumference, creating a functional valve. The Mitralign valve won CE Mark approval in the European Union in February 2016; clinical programs are under way in Europ...



Eudamed accessibility for medical device regulators outside of Europe

Wed, 21 Feb 2018 12:00:05 +0100

By Ronald Boumans, Emergo Group The European Commission is considering extending access to the Eudamed medical device database to non-European regulators to boost sharing of device safety information, potentially creating a new global data exchange standard for the industry. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees. The post Eudamed accessibility for medical device regulators outside of Europe appeared first on MassDevice. (Source: Mass Device)

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Medical Design and Manufacturing Challenges to Be Explored at ADM Cleveland

Wed, 21 Feb 2018 00:08:37 +0100

The challenges of medical manufacturing, from evolving quality systems requirements to determining whether to outsource a technology or keep it in house, will be explored at free conference sessions during the upcoming Advanced Design & Manufacturing (ADM) Expo in Cleveland, OH. The trade show and conference comes to the Huntington Convention Center of Cleveland on March 7 and 8. A panel discussion on March 7 will dive into ISO 13485 certification, including the latest version of the international standard for medical device quality management systems. ISO 13485:2016 introduces a number of revisions that medical device manufacturers and their critical suppliers must implement if they are to achieve compliance by the March 1, 2019, deadline. First and foremost is a broadening of risk ma...



PRC Clinical Celebrates 15 Years Of CRO Services At Outsourcing In...

Wed, 21 Feb 2018 00:00:00 +0100

PRC Clinical, The Full-Service CRO Headquartered in Burlingame, CA, Will Present CRO Services To Pharmaceutical, Biotech, Regenerative Medicine and Medical Device Companies At The Outsourcing in...(PRWeb February 21, 2018)Read the full story at http://www.prweb.com/releases/2018/02/prweb15228534.htm (Source: PRWeb: Medical Pharmaceuticals)



Under Pressure: MiMedx Faces an Uncertain Future

Tue, 20 Feb 2018 22:19:08 +0100

An internal investigation has thrown MiMedx into a state of uncertainty. The Marietta, GA-based company said Tuesday it is postponing the release of its financial results and the filing of its Form 10-K for 2017, while independent legal and accounting advisors investigate allegations regarding the company's sales and distribution practices at the company. MiMedx said its executives are also reviewing the accounting treatment of certain distributor contracts.  The company's stock (Nasdaq: MDXG) fell 39.53% Tuesday, closing at $8.75, and at least one analyst decided to downgrade the stock citing "too much uncertainty." If the investigation doesn't find any wrongdoing, MiMedx shares are likely to bounce back, said Mike Matson of Needham & Co. "And if the investigation does find serious ...



Whistleblower Complaint Against Obalon Found to be Unjustified

Tue, 20 Feb 2018 22:01:11 +0100

Late last month Obalon pulled the plug on a $35 million stock offering to investigate allegations of improper revenue recognition during the company's fourth quarter. Obalon said that investigation is now complete and the allegations in the complaint are without merit. "We took the whistleblower complaint very seriously and conducted a thorough investigation," said Les Howe, chair of Obalon's audit committee. "The investigators found no merit to any of the whistleblower allegations, determined that preliminary revenues were not misrepresented and that management did nothing to mislead investors." Prior to its U.S. launch in January 2017, Obalon worked with its audit committee to develop a robust procedure for appropriately recognizing revenue, according to CFO Bill Plovanic. "We hired a d...



Medtronic is Making the Most of Value-Based Care

Tue, 20 Feb 2018 21:33:34 +0100

Medical device companies of all sizes have embraced value-based healthcare in recent years, and one of the industry's top companies is now beginning to see its value-based care programs pay off. "I know I have spoken a lot about value-based healthcare, but I'm particularly pleased to see this translate into real numbers, which have real differentiating value for Medtronic," CEO Omar Ishrak said during Medtronic's third-quarter earnings call Tuesday, according to Seeking Alpha transcripts. Learn more about the future of innovation in the value-based care system at the BIOMEDevice Boston conference, April 18-19, 2018. Use promo code "MDDI" for 20% off registration. Ishrak said the company's Tyrx absorbable antibacterial envelope is just one example of innovation being linked directly to an ...

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New Vaginal Mesh Implant Material Could Reduce Complications, Accelerate Healing

Tue, 20 Feb 2018 21:00:01 +0100

Vaginal mesh implants made of polypropylene have caused severe medical complications in millions of women across the world, and medical manufacturers from Johnson & Johnson to Bard, acquired by BD last year, have been mired in lawsuits as a result. Now, scientists at the University of Sheffield in the United Kingdom have developed an alternative polyurethane material to treat pelvic organ prolapse and incontinence that is better suited for use in the pelvic floor. Moreover, they have embedded the material with estrogen, which is released into the surrounding pelvic tissue to form new blood vessels and accelerate the healing process. The research is published in the Journal of Neurourology and Urodynamics. Polypropylene mesh can be beneficial and carries little risk to the patient when ...



FDA removed 10% of medtech establishments from its registration database: Here ’s why

Tue, 20 Feb 2018 20:53:03 +0100

David Lennarz, Registrar Corp. The U.S. FDA has removed 2,546 medical device establishments from its active registration database.  As of Feb. 19, the FDA database contained 24,578 registered establishments, compared to 27,124 registered establishments on Feb. 2. So why did FDA remove the registrations? Get the full story on our sister site Medical Design & Outsourcing.  The post FDA removed 10% of medtech establishments from its registration database: Here’s why appeared first on MassDevice. (Source: Mass Device)



UPDATE: Robotics delay pushes Medtronic down despite fiscal Q3 beats

Tue, 20 Feb 2018 19:30:13 +0100

Medtronic (NYSE:MDT) shares took a hit today after the world’s largest medical device maker said its robot-assisted surgery platform has fallen behind schedule, despite fiscal third-quarter results that topped the consensus forecast on Wall Street. Fridley, Minn.-based Medtronic had predicted first-in-human cases during the fiscal year ending in April, with a full launch following in fiscal 2019. But during a conference call with investors today discussing the Q3 numbers, chairman & CEO Omar Ishrak said the timetable has gotten longer. “We are enthusiastic about the development of our surgical robotics platform, which we expect will strengthen our strategy of advancing minimally invasive procedures and we continue to make progress towards its launch. While we had intended f...



J & amp;J Acquisition Could Give Stryker a Run for Its Money in Robotics

Tue, 20 Feb 2018 19:25:41 +0100

Johnson & Johnson is taking a deeper dive into the surgical robotics market through its latest acquisition. The New Brunswick, NJ-based company, through its French affiliate Apsis, will pick up Orthotaxy, a privately held developer of software-enabled surgical technologies, including a differentiated robotic-assisted surgery solution, for an undisclosed sum. J&J said the technology is currently in early-stage development for total and partial knee replacement, and the company plans to broaden its application for a range of orthopedic surgery procedures. Network with your colleagues in medtech at ADM Cleveland, March 7–8, 2018.   "Our goal is to bring to market a robotic-assisted surgery technology that is an integral part of a comprehensive orthopedics platform, delivering va...



Pacemakers, other devices at risk for hacking, study says

Tue, 20 Feb 2018 19:04:41 +0100

Medical devices like pacemakers and insulin pumps are at risk for hacking the could have deadly consequences, warns a new report by the American College of Cardiology. (Source: the Mail online | Health)

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Cincinnati medical device maker gets board refresh

Tue, 20 Feb 2018 16:58:32 +0100

Medical device maker AtriCure Inc. revealed today that Scott Drake will become chairman of the board of the publicly traded company in May. Drake, previously CEO of medical device maker Spectranetics Corp., has been a director of Mason-based AtriCure since September 2013. The company (Nasdaq: ATRC) is best known for making medical devices to treat atrial fibrillation, a common malady characterized by an irregular and fast heartbeat. Richard Johnston, a director of Atricure since 2002 and chairman… (Source: bizjournals.com Health Care:Biotechnology headlines)



Johnson & Johnson picks up French robot-assisted surgery firm Orthotaxy

Tue, 20 Feb 2018 14:55:05 +0100

Johnson & Johnson (NYSE:JNJ) said today that its medical device business paid an undisclosed amount to acquire French robot-assisted surgery company Orthotaxy. J&J said it plans to expand the early-stage technology from total and partial knee replacements into other orthopedic surgeries as part of its bid to create a new robot-assisted platform using “enabling technologies to personalize procedures, optimize surgery and bring value to customers and patients.” “Our goal is to bring to market a robotic-assisted surgery technology that is an integral part of a comprehensive orthopedics platform, delivering value to patients, physicians and healthcare providers across the episode of care,” DePuy Synthes chairman Ciro Rӧmer said in prepared remarks. “The t...






Johnson and Johnson Medical Devices Companies Acquire Orthotaxy to Develop Next-Generation Robotic-Assisted Surgery Platform in Orthopaedics

Tue, 20 Feb 2018 14:08:42 +0100

PARIS, Feb. 20, 2018 -- (Healthcare Sales & Marketing Network) -- Johnson & Johnson Medical Devices Companies, through French affiliate Apsis S.A.S., announced today the acquisition of Orthotaxy, a privately-held developer of software-enabled surgery tech... Devices, Mergers & Acquisitions Johnson & Johnson, DePuy Synthes, Orthotaxy (Source: HSMN NewsFeed)



Medtronic ’ s Q3 beats expectations

Tue, 20 Feb 2018 12:25:13 +0100

Medtronic (NYSE:MDT) posted fiscal third-quarter results today that topped the consensus forecast on Wall Street, despite taking a $2.2 billion hit from last year’s tax reforms. The Fridley, Minn.-based medical device titan posted losses of -$1.39 billion, or -$1.03 per share, on sales of $7.37 billion for the three months ended Jan. 26, compared with profits of $821 million on sales growth of 1.2% compared with fiscal Q3 2017. Adjusted to exclude one-time items, earnings per share were $1.18, a penny ahead of The Street, where analysts were looking for sales of $7.20 billion. “Our results reflect a solid quarter for Medtronic, and as we expected, a strong turnaround from the first half of our fiscal year,” chairman & CEO Omar Ishrak said in prepared remarks. “W...

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Blockchain Based Medical Device from NnBU Set to Raise €15million in ICO

Mon, 19 Feb 2018 14:02:49 +0100

New Neonatal Birth Unit is a World First to Improve Health Outcomes of Babies Born by C-Section NICOSIA, Cyprus, February 19, 2018 -- (Healthcare Sales & Marketing Network) --Today, Monday February 19 2018, NnBU Holdings Ltd (https://nnbu.io) announces... Devices, Venture Capital NnBU Holdings, blockchain, neonatal birth unit (Source: HSMN NewsFeed)



Are we poisoning our children with plastic?

Mon, 19 Feb 2018 06:00:05 +0100

The chemical BPA is widely added to food and drink packaging, and more than 80% of teenagers have it in their bodies. But how dangerous is it?Can exposure to plastics harm your health? It ’s a question currently being explored by researchers after a recent study suggested that traces of a synthetic chemical called Bisphenol A (BPA) can be found inmore than 80% of teenagers. BPA is added to plastic to create a special form called polycarbonate plastic, used in making robust, impact-resistant materials for everything from food and drink packaging to DVD cases and medical devices. First created in 1891, it has been used commercially since the 1950s and is now one of the most commonly produced chemicals in the world, with 3.6bn tonnes of BPA generated every year.The problem is that BPA can b...



FDA Oks First Blood Based Concussion Detection Test

Mon, 19 Feb 2018 04:02:44 +0100

A new blood-based test could help change the way TBI’s such as concussions are detected in patients. FDA recently granted a De Novo request to Banyan Biomarkers to market the Banyan Brain Trauma Indicator (BTI). “The goal standard right now is the CT scan and it’s better than anything else out there,” Henry Nordhoff, chairman and CEO of Banyan Biomarkers, told MD+DI. “But the problem with CT is the cost; the time it takes; and the amount of ionizing radiation that’s delivered to the brain. It’s particularly dangerous when it’s a developing brain. You’re getting about 100 times the ionizing radiation in a brain scan that you’re getting in a chest X-ray.” The San Diego-based company’s test identifies two brain-specific protein biomarkers (Ubiquitin Carboxy-terminal Hy...



FDA OKs First Blood-Based Concussion Detection Test

Fri, 16 Feb 2018 21:43:46 +0100

A new blood-based test could help change the way TBI’s such as concussions are detected in patients. FDA recently granted a De Novo request to Banyan Biomarkers to market the Banyan Brain Trauma Indicator (BTI). “The goal standard right now is the CT scan and it’s better than anything else out there,” Henry Nordhoff, chairman and CEO of Banyan Biomarkers, told MD+DI. “But the problem with CT is the cost; the time it takes; and the amount of ionizing radiation that’s delivered to the brain. It’s particularly dangerous when it’s a developing brain. You’re getting about 100 times the ionizing radiation in a brain scan that you’re getting in a chest X-ray.” The San Diego-based company’s test identifies two brain-specific protein biomarkers (Ubiquitin Carboxy-terminal Hy...



DOD-Backed MeMed Feels the Need for Speed

Fri, 16 Feb 2018 20:49:11 +0100

An Israeli startup that has developed a platform to differentiate between viral and bacterial infections in 15 minutes just got a big boost toward bringing the product to market. The U.S. Department of Defense (DoD) has given Haifa-based MeMed a $4 million grant to fund its manufacturing efforts. MeMed’s technology measures three blood-borne immune markers to detect whether a patient has a bacterial or viral infection. Its first generation product, ImmunoXpert, has been cleared for use in laboratories in the EU, Switzerland, and Israel. The platform under development, ImmunoPoC, is designed for point-of-care use to help clinicians decide whether or not to treat an infection with antibiotics. It does not have FDA approval. Antibiotic overuse has driven the emergence of multi-drug resistan...

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BD Accuses Cytek of Stealing Trade Secrets

Fri, 16 Feb 2018 20:38:41 +0100

Becton Dickinson (BD) is the latest medtech company to take a competitor to court for alleged trade secret theft. The company recently filed a lawsuit against Cytek Biosciences and nine former BD employees, claiming that when these employees left BD to work for Cytek they retained and misused BD's "valuable, highly confidential, proprietary information," including thousands of technical files they had downloaded from BD's computer systems onto removable storage media while still employed with the company. "Cytek recently hired away nearly a dozen scientists, engineers, and business people from BD and employed them to develop products that compete unfairly with their former company's product lines," BD said in the complaint. The company said it gave Cytek a list of serial numbers of unr...



Valeritas Presents Data Demonstrating V-Go & #194; & #174; Wearable Insulin Delivery Device ...

Fri, 16 Feb 2018 19:02:52 +0100

BRIDGEWATER, N.J., Feb. 15, 2018 - Valeritas Holdings, Inc. (NASDAQ:VLRX), a medical technology company which offers patients with type 2 diabetes V-Go® Wearable Insulin Delivery device, a simple, affordable, all-in-one insulin delivery option that is worn like a patch and can eliminate the need for taking multiple daily shots, announced today it presented positive findings from its MOTIV4CONTROL study as a poster at The 11th International Conference on Advanced Technologies&...This story is related to the following:Medical Devices (Source: Industrial Newsroom - Health, Medical and Dental Supplies)



These trends have made medical device manufacturing what it is today

Fri, 16 Feb 2018 18:07:12 +0100

About 10 years ago, there were a number of notable trends and market forces which began to, once again, change how the medical device manufacturing sector brought its products to market. They’re still shaping the market we have today. Andrew Potter, Bonifacio Consulting Services, and Chris Delporte [Image from Unsplash]Perhaps the true measure of a forward-thinking industry is its ability to evolve to meet new market challenges, demands and opportunities. The medical device industry — and certainly the contract manufacturing sector that has grown over the last two decades into an integral part of medtech’s success story — not only has adeptly changed to meet new clinical demands, but also has, as part of that process, reshaped its manufacturing models to better respond to shift...



Attivo Networks receives validation from BD for BOTsink cybersecurity solution

Fri, 16 Feb 2018 17:59:13 +0100

[Image courtesy of Blogtrepreneur on Flickr, per Creative Commons 2.0 license]Attivo Networks recently announced that it has received validation through a BD Product Security Partner Program for its BOTsink cybersecurity deception solution when used with BD devices. The company recently expanded its IOT portfolio and the BD collaboration will allow for improved detection capabilities against cyber threats that impact medical devices. The deception-based threat detection in the BOTsink features decoys and lures that misdirect potential attackers from production assets. Through the collaboration, BOTsink decoys will provide software on certain BD products that will create mirror-match decoy authenticity. This will create an illusion where a potential attacker will not be able to tell what is...



Recent Study Looks at How Consumers Use Wearables That Generate Biometric data and Whether Such Data Might Be Valuable for Physicians and Medical Laboratories

Fri, 16 Feb 2018 15:50:22 +0100

Precision medicine programs can benefit from wearable usage data; however, little information has been collected on personalities and behaviors of the device users Wearables medical devices have the potential to monitor some of the same biomarkers used in medical laboratory tests today. In addition, these mobile technologies can make it possible for clinical laboratories to […] (Source: Dark Daily)

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Tandem inks distribution deal in Scandinavia for insulin pumps

Fri, 16 Feb 2018 13:33:33 +0100

Tandem Diabetes Care (NSDQ:TNDM) has inked a distribution agreement with Rubin Medical to commercialize the medical device company’s t:slim X2 insulin pump, insulin cartridges and t:lock infusion sets in Sweden, Norway and Denmark. According to the terms of the deal, Rubin Medical is slated to perform all sales, marketing and customer training for Tandem’s devices. Get the full story at our sister site, Drug Delivery Business News. The post Tandem inks distribution deal in Scandinavia for insulin pumps appeared first on MassDevice. (Source: Mass Device)



Gambia:Sharab Medical Center Receives Grant

Fri, 16 Feb 2018 10:43:18 +0100

[Foroyaa] Mr. Daisuke Enomoto, Second Secretary of the Japanese Embassy in The Gambia, on Tuesday 13th February 2018, presided over a signing ceremony dedicated for a grant for the execution of a project to supplying medical equipment to Sharab Medical Center . (Source: AllAfrica News: Health and Medicine)



Edwards Adds Bold New Chapter to TAVR Story

Thu, 15 Feb 2018 23:02:38 +0100

Edwards Lifesciences just might have leaped-frogged over some of its competitors in the burgeoning  TAVR market. The undisputed TAVR pioneer has received CE mark for its Centera valve to treat severe, symptomatic aortic stenosis patients at high risk of open-heart surgery. The Edwards Centera valve is repositionable and retrievable and can be delivered through a low-profile, 14-French, motorized delivery system. The company said the device is packaged with the valve fully pre-attached to the delivery system, which helps with simple and rapid device preparation. Network with your colleagues in medtech at ADM Cleveland, March 7–8, 2018.  “We think today’s approval augments the firm’s momentum in the TAVR market,” said Jason Mills, an analyst with Canaccord Genuity. CE mark for...



New biopolymer liquid bandage has received FDA approval

Thu, 15 Feb 2018 20:36:09 +0100

(Natural News) A liquid skin bandage has been approved for licensing and sale by the U.S. Food and Drug Administration (FDA). Known as ElaSkin, the biopolymer liquid bandage is the first commercial product by the biomaterials and medical device start-up, Aleo BME. ElaSkin possesses a variety of characteristics that help make it a “best-in class technology,”... (Source: NaturalNews.com)



Recently Approved Device- Consumer Information on: Aptima HBV Quant assay - P170025 https://go.usa.gov/xnF3d   #MedicalDevice

Thu, 15 Feb 2018 20:30:28 +0100

Recently Approved Device- Consumer Information on: Aptima HBV Quant assay - P170025 https://go.usa.gov/xnF3d  #MedicalDevice (Source: Food and Drug Adminstration (FDA): CDRHNew)

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MSQA Insights- Direct-to-Patient Mammogram Results: It ’ s the Law- https://go.usa.gov/xnF3E   #MedicalDevice

Thu, 15 Feb 2018 20:00:47 +0100

MSQA Insights- Direct-to-Patient Mammogram Results: It’s the Law- https://go.usa.gov/xnF3E  #MedicalDevice (Source: Food and Drug Adminstration (FDA): CDRHNew)



Supplier Stories for the Week of February 11

Thu, 15 Feb 2018 19:32:07 +0100

(Source: MDDI)



FDA authorizes marketing of 1st blood test to aid in eval of concussion in adults. Most patients eval'd for concussion w/ a CT scan don't have detectable brain tissue damage. This quick testing option helps reduce the need for CT scans, radiation exposure https://go.usa.gov/xnFxq   pic.twitter.com/srv921peN7

Thu, 15 Feb 2018 18:10:02 +0100

FDA authorizes marketing of 1st blood test to aid in eval of concussion in adults. Most patients eval'd for concussion w/ a CT scan don't have detectable brain tissue damage. This quick testing option helps reduce the need for CT scans, radiation exposure https://go.usa.gov/xnFxq  pic.twitter.com/srv921peN7 (Source: Food and Drug Adminstration (FDA): CDRHNew)



Perflow Medical Closes $12 Million in Financing to Treat Complex Neurovascular Disorders

Thu, 15 Feb 2018 15:15:03 +0100

Announces successful completion of over 50 commercial cases with the Stream™ Dynamic Neuro-Thrombectomy Net TEL AVIV, Israel, Feb. 15, 2018 -- (Healthcare Sales & Marketing Network) -- Perflow Medical, an Israeli-based medical device company that devel... Devices, Interventional, Neurology, Venture Capital Perflow Medical, CEREBRAL NET, Thrombectomy (Source: HSMN NewsFeed)



Pittsburgh medical device firm bought for $250M

Thu, 15 Feb 2018 15:06:44 +0100

A medical technology company based in London announced an agreement to buy a Pittsburgh firm focused on advanced cardiopulmonary temporary support solutions for $250 million. LivaNova PLC said it is acquiring CardiacAssist Inc., which does business as TandemLife and is based in O’Hara Township. The deal is expected to close by the end of June. LivaNova said upfront costs of the transaction total $200 million, with up to $50 million in contingent considerations based on regulatory milestones. TandemLife’s… (Source: bizjournals.com Health Care News Headlines)

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Edwards Lifesciences wins CE Mark for Centera TAVR

Thu, 15 Feb 2018 14:57:00 +0100

Edwards Lifesciences (NYSE:EW) said today it won CE Mark approval in the European Union for its self-expanding transcatheter Centera aortic heart valve, with indications for treating symptomatic aortic stenosis patients at high risk of open-heart surgery. The Centera valve is designed to be repositionable and retrievable, and is delivered through the use of a 14 French motorized delivery system in which the valve is pre-attached to the mechanism for quick preparation, the Irvine, Calif.-based company said. “With the Edwards Centera valve, European clinicians and their patients may now benefit from a self-expanding TAVR option that has demonstrated exceptional clinical safety and performance outcomes in the high surgical risk population. Enhanced design features of the Centera valve...



Pittsburgh medical device firm bought for $250M

Thu, 15 Feb 2018 14:40:25 +0100

A medical technology company based in London announced an agreement to buy a Pittsburgh firm focused on advanced cardiopulmonary temporary support solutions for $250 million. LivaNova PLC said it is acquiring CardiacAssist Inc., which does business as TandemLife and is based in O’Hara Township. The deal is expected to close by the end of June. LivaNova said upfront costs of the transaction total $200 million, with up to $50 million in contingent considerations based on regulatory milestones. TandemLife’s… (Source: bizjournals.com Health Care:Biotechnology headlines)



Government to come out with new pharma policy: Ananth Kumar

Thu, 15 Feb 2018 13:03:39 +0100

The big healthcare initiative announced in the budget for 2018-19 seeks to cover 10 crore households requires many verticals -- infrastructure, human resources and pharma and medical device products. (Source: The Economic Times Healthcare and Biotech News)



Top Medtech Companies of 2017: Notable Newcomers

Thu, 15 Feb 2018 12:02:36 +0100

(Source: MDDI)



LivaNova Pumps Up its Heart Portfolio with TandemLife Deal

Thu, 15 Feb 2018 01:08:38 +0100

London-based LivaNova has been cutting deals left and right lately in an effort to focus on its areas of strength, such as cardiac surgery and neuromodulation. That's the reason the company gave last year for shedding its cardiac rhythm management business, and then for acquiring ImThera Medical.  Now the company has its sights on Pittsburgh, PA-based TandemLife. Don't miss the Advanced Design and Manufacturing Conference and Expo, March 7-8, 2018, in Cleveland, OH. LivaNova has agreed to pay $200 million upfront and up to $50 million more once certain regulatory milestones have been met.  TandemLife's advanced cardiopulmonary temporary support solutions are expected to compliment LivNova's cardiac surgery offerings. TandemLife sells four product systems, all built around a common pump ...

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Medical Adhesive Secures a Golden Mousetrap Award

Thu, 15 Feb 2018 00:57:47 +0100

As wearable medical devices continue to emerge, a growing older population coupled with an increasing incidence of chronic diseases requiring active monitoring is driving the need for durable yet comfortable adhesives, reports John Dugas, global business manager, 3M’s Critical and Chronic Care Solutions Division. “Whether it’s affixed for several hours, a day, or even a week, the device needs to stay attached to do its job,” he said. 3M’s 4076 Extended Wear Medical Tape, launched last August, was recently recognized with a Golden Mousetrap Award in the Materials & Assembly: Adhesives category. “Medical device manufacturers and engineers needed a long-term wear adhesive solution that increases patient comfort and provides a strong and reliable bond in challenging applicatio...



Biocoat, Inc. Names Jim Moran President and CEO

Thu, 15 Feb 2018 00:00:00 +0100

Moran brings extensive medical device and startup expertise to growing biomaterial coatings company(PRWeb February 15, 2018)Read the full story at http://www.prweb.com/releases/2018/02/prweb15214440.htm (Source: PRWeb: Medical Pharmaceuticals)



Mazor CEO: Robotics is Here to Stay

Wed, 14 Feb 2018 22:26:34 +0100

During Mazor Robotics' fourth-quarter earnings call, executives mentioned Medtronic almost as much as they mentioned their own company. And for good reason.  The company received 24 purchase orders for its Mazor X robotic system in the fourth quarter of 2017, and all but one of those orders came from Medtronic. Under a global distribution sale that occurred ahead of schedule last year, Medtronic has assumed exclusive global responsibility for Mazor X's commercial activity for spine surgery. Learn how to design a surgical robotic system from an expert in the field at BIOMEDevice Boston on April 18, 2018. Mazor CFO Sharon Levita said the global distribution agreement with Medtronic is expected to deliver significant savings to Mazor by reducing the company's full-year 2018 sales and marke...



Is FDA Getting More Cozy with AI?

Wed, 14 Feb 2018 20:25:50 +0100

The use of artificial intelligence (AI) is undoubtedly on the rise in healthcare. From fledging medtech companies to established giants like Watson IBM—many firms are riding the current AI wave. Not only are companies embracing technology, but so is FDA. Recently the agency gave approval to San Francisco-based Viz.ai’s Contact application, a type of clinical decision support software designed to analyze CT results that could notify providers of a potential stroke in their patients. “What it’s doing is comparing the imaging features in that patient with the millions of images it has been trained on in the past, in order to identify a specific disease, which is a large vessel occlusion,” Chris Mansi MD, president and CEO of Viz.ai, told MD+DI. Once the Contact Application analyz...



FDA authorizes marketing of 1st blood test to aid in eval of concussion in adults. Most patients eval'd for concussion w/ a CT scan don't have detectable brain tissue damage. This quick testing option helps reduce the need for CT scans, radiation exposure https://go.usa.gov/xn6vh   pic.twitter.com/QQzznfsvmI

Wed, 14 Feb 2018 18:30:34 +0100

FDA authorizes marketing of 1st blood test to aid in eval of concussion in adults. Most patients eval'd for concussion w/ a CT scan don't have detectable brain tissue damage. This quick testing option helps reduce the need for CT scans, radiation exposure https://go.usa.gov/xn6vh  pic.twitter.com/QQzznfsvmI (Source: Food and Drug Adminstration (FDA): CDRHNew)

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Cardiovascular Systems launches Diamondback 360 EL in the US, touts 1st patients treated

Wed, 14 Feb 2018 17:58:38 +0100

Cardiovascular Systems (NSDQ:CSII) said today it launched its FDA-cleared extended length Diamondback 360 peripheral orbital atherectomy device in the US and that the first commercial patients have been treated with the device. The first procedures were performed at the Detroit Medical Center Heart Hospital by Dr. Mahir Elder and at the Arkansas Heart Hospital by Dr. Ian Cawich and Dr. Vasili Lendel, the St. Paul, Minn.-based company said. “From a physician’s perspective, radial access is a viable alternative that allows us to minimize bleeding and avoid commonly diseased femoral arteries. Additionally, it allows for both bilateral diagnostics and interventions while also eliminating the need for femoral closure devices. The result for patients is a far less invasive procedure,&#...



Titan Medical touts hitting all milestones in 2017 financial results

Wed, 14 Feb 2018 15:25:31 +0100

Titan Medical (TSX:TMD) Titan Medical late yesterday released its full year 2017 financial results, touting that it met all its milestones during the year and that its Sport system was used in the first single-port procedures. The Toronto-based company reported research and development expenses of $12.9 million for the year, down from $22.6 million the company spent the previous year, with reported losses of approximately $33.6 million for the year, up from $23.3 million it reported in 2016. “I joined Titan Medical in January 2017 and based on our achievements this past year, I am more confident than ever in our future.  With the addition of Dr. Perry Genova, our senior vice president of R&D, and Curtis Jensen, our vice president of quality and regulatory affairs, we now have a...



MD & M West: 10 technologies you should know

Tue, 13 Feb 2018 21:35:42 +0100

MD&M West is one of the largest medical device manufacturing events in the world, so it’s easy to get lost on the show floor. Even if you were in Anaheim, Calif., for the event last week, you may have missed a lot. From a new robotics insights display from Rethink Robotics to a disinfectant-resistant plastic from Eastman to Guill’s extrusion tool with single-point concentricity adjustment, here are 10 things you may have missed at MD&M West. Next>> Senior editor Heather Thompson contributed with the final two slideshow items. The post MD&M West: 10 technologies you should know appeared first on MassDevice. (Source: Mass Device)



Ain & #039;t That a Pill: Device Could Replace Needles

Tue, 13 Feb 2018 21:01:45 +0100

Rani Therapeutics has a daunting task ahead of it. The privately held company wants to change the way some pharmaceuticals are delivered to patients. Some drugs are delivered through needles  — a method that isn’t ideal for many patients.  Rani is in the process of developing an ingestible drug-delivery pill. The San Jose, CA-based company’s RaniPill is an oral capsule that protects a drug therapy until it is ready to be delivered across the intestinal wall into the bloodstream. The RaniPill has small needles to inject the drugs into the intestinal wall once ingested. The needles will dissolve naturally. Rani Therapeutics recently raised $53 million and has brought in a total of $142 million since it spun out from InCube Lab in 2012. New investors include GeneScience Pharmaceutica...



Report: Amazon gearing up for entry into medical supplies biz

Tue, 13 Feb 2018 20:33:03 +0100

Amazon (NSDQ:AMZN) is looking to up the ante in its medical supplies business and turn the unit into a major supplier to US hospitals and clinics, according to a Wall Street Journal report. The online mega retailer has initiated a trial of a new system testing to see if it can use its Amazon Business site to supply healthcare products to a large midwestern hospital and its approximately 150 outpatient facilities, according to the report. The system is customized to the hospital’s catalog of supplies and allows employees to compare prices on the Amazon Business marketplace to those it negotiates with through distributors, according to the Wall Street Journal. When questioned about the test, Amazon said it is looking to offer a “marketplace concept” to hospitals that would not...

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India Cuts Stent Prices by More Than 7 Percent India Cuts Stent Prices by More Than 7 Percent

Tue, 13 Feb 2018 19:22:16 +0100

India has cut prices of some stents by about 7.6%, a government body said on Monday, in the latest setback for the country's $5 billion medical device industry.Reuters Health Information (Source: Medscape Medical News Headlines)



#DidYouKnow https://twitter.com/FDATobacco/status/963457773462843392   …

Tue, 13 Feb 2018 18:52:56 +0100

#DidYouKnow https://twitter.com/FDATobacco/status/963457773462843392 … (Source: Food and Drug Adminstration (FDA): CDRHNew)



Why Amazon Has Medical Suppliers on Edge

Tue, 13 Feb 2018 18:11:35 +0100

Amazon sure knows how to set an industry on edge. The Wall Street Journal reported Tuesday that Amazon wants to become a major medical supplier, but the company has yet to make any healthcare-related announcements beyond its new healthcare venture with Berkshire Hathaway and JPMorgan Chase that was unveiled late last month. The company already offers a range of professional medical products through its business-to-business marketplace, Amazon Business. Get up to speed on key industry topics including 3D printing, smart manufacturing, hybrid vehicles, collaborative robots, machine learning, IIoT, and more at the free Advanced Design and Manufacturing (ADM) Conference and Expo March 7-8, 2018 in Cleveland, OH.  Analysts probed Amazon executives for information about its investments in hea...



Insulet ’s closed-loop insulin delivery algorithm succeeds in feasibility study

Tue, 13 Feb 2018 15:20:09 +0100

The algorithm used in Insulet‘s (NSDQ:PODD) closed-loop insulin delivery system performed well in a 58-patient safety and feasibility study, according to a study published today in Diabetes Technology & Therapeutics. Insulet’s device, which is still in development, combines an insulin dosing algorithm, the OmniPod insulin patch pump and Dexcom‘s (NSDQ:DXCM) continuous glucose monitor into one system that automates insulin delivery based on the user’s blood sugar levels. Get the full story at our sister site, Drug Delivery Business News. The post Insulet’s closed-loop insulin delivery algorithm succeeds in feasibility study appeared first on MassDevice. (Source: Mass Device)



Abiomed touts expanded Impella heart pump indication, launches Women ’s Initiative

Tue, 13 Feb 2018 15:05:14 +0100

Abiomed (NSDQ:ABMD) said today it won expanded FDA premarket approval for its Impella 2.5, Impella CP, Impella 5.0 and Impella LD heart pumps, now cleared to provide treatment for heart failure associated with cardiomyopathy leading to cardiogenic shock, including peripartum and postpartum cardiomyopathy. The approval follows a previous FDA indication the Danvers, Mass.-based company won in April 2016 that cleared the device for treating acute myocardial infarction cardiogenic shock and post-cardiotomy cardiogenic shock. Abiomed touts its Impella heart pumps as the only percutaneous temporary ventricular support devices with FDA approval for cardiogenic shock in the setting of cardiomyopathy, according to a press release. The company also announced a new Women’s Initiative, which will ...

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Diabetes clinic taps DarioHealth for blood glucose monitoring tech

Tue, 13 Feb 2018 14:04:03 +0100

DarioHealth (NSDQ:DRIO) has partnered with the Diabetes and Endocrinology Consultants of Pennsylvania to bring its blood glucose monitoring system to the 5,000-patient facility. The company’s blood glucose monitor, which syncs with Dario’s diabetes management app, connects via a headphone jack to a mobile device, helping diabetes patients monitor their blood glucose throughout the day. The app also records carbohydrate intake, insulin use and physical activity. Get the full story at our sister site, Drug Delivery Business News. The post Diabetes clinic taps DarioHealth for blood glucose monitoring tech appeared first on MassDevice. (Source: Mass Device)



Ashfield U.S. hires two senior executives for new Medical Affairs business unit

Tue, 13 Feb 2018 12:03:44 +0100

The new Medical Affairs business unit will combine Ashfield’s existing Medical Information, Pharmacovigilance and Medical Science Liaison services. The unit is being established as part of Ashfield’s five-year growth plan to provide its clients leading services across the entire healthcare value chain by investing in people, technology and infrastructure. Amy’s role will be focused on raising awareness of Ashfield’s Medical Affairs capabilities and executing the flexible and scalable programs clients require. She will be located in the Fort Washington, PA corporate headquarters of Ashfield U.S.   Amy assumes her position at Ashfield U.S. having most recently served as Director, Regulatory Advertising & Promotion for the Pharmaceutical Sector within the Johnson & Johns...



Could a Disinfecting Robot Help Tackle HAIs?

Tue, 13 Feb 2018 04:17:38 +0100

The Centers for Disease Control and Prevention (CDC) estimates that “on any given day, about one in 25 hospital patients has at least one healthcare-associated infection.” Given such risk to patients, let alone the cost of treatment, hospitals and healthcare systems are looking to for ways to reduce these numbers. One solution, a disinfecting robot employing short-wavelength ultraviolet radiation (UVC), is designed to disinfect an entire room in one cycle. A recent study explored some of the challenges to implementation and strategies to overcome them. “The CDC recently stated that C. diff rates are at an all-time high, and hospital-acquired infections continue to cost health care facilities precious lives and dollars,” explained Chuck Dunn, CEO and President of Tru-D SmartUVC. Th...



VC Firms Still Find Liquid Biopsy Sexy

Mon, 12 Feb 2018 20:05:48 +0100

DiaCarta’s recent series B round shows that the promise of liquid biopsy for cancer detection continues to be attractive to investors. The Richmond, CA-based company revealed it has completed a $45 million funding round, with the closing led by Fortune Fountain Capital and subscribed to by Good Health Capital. The series B financing will support DiaCarta’s core XNA technology platform for early cancer detection and help the company expand its diagnostic products for non-invasive early detection and monitoring of cancers. The company said the plan is to perform the clinical trials for noninvasive early cancer detection, and include recurrent and monitoring indications. Funding will also support the commercial launch of ColoScape, a highly sensitive in vitro diagnostic assay for the dete...



Avalon NeoMTA Plus ® Named Top Endodontic Reparative Cement for Fourth Straight Year

Mon, 12 Feb 2018 19:00:00 +0100

Easy-mixing, versatile, yet highly affordable bioceramic again honored by THE DENTAL ADVISORHOUSTON, TEXAS, February 7, 2018 —Avalon Biomed, a division of NuSmile Ltd., announced today that its Avalon NeoMTA Plus has been named “Top Product” for the Endodontic Reparative Cement category by THE DENTAL ADVISOR for the fourth consecutive year.“We’re thrilled to have THE DENTAL ADVISOR’s expert group of clinical advisors bestow this prestigious honor on Avalon NeoMTA Plus four years in a row,” said Mark Binford, Avalon Biomed Senior Vice President. “We pride ourselves on this breakthrough product’s ability to offer endodontist s and general dentists a combination of versatility, ease of use, and remarkable affordability they simply can’t get from any other dental bioceramic...

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Training the Trainers to Ensure Customer Satisfaction

Mon, 12 Feb 2018 17:59:13 +0100

Medical device manufacturers have a thorough understanding of the science behind their products, every indication of use, and the cost savings or patient benefit when the device is used in practice. And they should, given the hundreds or thousands of hours in clinical verifications and trials required to receive regulatory clearance. As brochures are made for educating decision makers on the features and benefits of a device and instructions for use (IFUs) are produced for customers to reference before and during use, a manufacturer training program needs to be reproducible while still accommodating the preferences of each customer healthcare organization to best inform their practitioners. A device implementation training program should aim to establish adaptable processes while adhering...



Mind: The First Step Toward a Personal Memory Maker?

Mon, 12 Feb 2018 17:36:01 +0100

Electric pulses to the brain help subjects store memory, scientists have found. But the road to perfecting recall remains daunting. (Source: NYT Health)



Medtech, healthcare stakeholders offer ideas to improve FDA oversight, regulation and patient access

Mon, 12 Feb 2018 17:24:06 +0100

Major players and medtech industry groups have offered their opinions as the FDA looks to review and improve its information collection requirements and regulatory oversight. Commentary came in from companies Johnson & Johnson (NYSE:JNJ), Abbott (NYSE:ABT) and Cook Medical and industry groups AdvaMed, the Medical Imaging & Technology Alliance, the Pharmaceutical Research and Manufacturers of America and the American Hospital Association, amongst many others. Across the board, companies and groups left commentary that was supportive of the FDA’s effort to reduce the burden on parties regulated by the agency to improve efficiency and innovation in the industry. In its comments, J&J prioritized improving avenues for communicating drug and device data to healthcare professiona...



India cuts stent prices by more than 7 percent

Mon, 12 Feb 2018 17:20:55 +0100

NEW DELHI (Reuters) - India has cut prices of some stents by about 7.6 percent, a government body said on Monday, in the latest setback for the country's $5 billion medical device industry. (Source: Reuters: Health)



European Medical Device Regulation: The Compliance Advantage

Mon, 12 Feb 2018 17:13:02 +0100

Nobody is in any doubt that the new European Medical Device Regulation (EU MDR) is on the agenda of compliance professionals in the medical devices industry. But is it far enough up on their priority list? MDR_fig1.png Early compliance to the European Medical Device Regulation—the outline of which was finally published in the Official Journal of the European Union on May 5, 2017—is crucial if manufacturers are to maintain access to EU markets, which in aggregate are economically larger than the United States. The MDR replaces both the previous Medical Device Directive (93/42/ EEC) and the Active Implantable Medical Device Directive (90/385/EEC), and entails a raft of changes to the oversight of many critical processes in manufacturing (see sidebar "Key Issues for Complianc...

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FDA adds new information about warfarin INR test meters to FDA website to help patients, caregivers, and health care providers use these devices safely and effectively. https://go.usa.gov/xnHFk   #MedicalDevice

Mon, 12 Feb 2018 16:00:41 +0100

FDA adds new information about warfarin INR test meters to FDA website to help patients, caregivers, and health care providers use these devices safely and effectively. https://go.usa.gov/xnHFk  #MedicalDevice (Source: Food and Drug Adminstration (FDA): CDRHNew)



Safety oversight options from medical device sponsors

Mon, 12 Feb 2018 13:57:52 +0100

Rachel Silver-Kessler, Director of Clinical Support Services, IMARC A safety monitoring group may be called many different things— a data monitoring committee, a data safety monitoring board, a clinical events committee, a medical monitoring group, among others. The sponsor will determine if and what type of safety monitoring group will be needed based on study risks. Medical device sponsors, according to 21 CFR 812.40 and 812.46, are responsible for monitoring clinical trials.  The regulations require that sponsors monitor a trial at a site by ensuring that an investigator is compliant with the federal regulations, agreements with the sponsor, the investigational plan, and the requirements set forth in the approval of the study by the IRB.  It is also the responsibility of the spon...



The New Health Care: Heart Stents Are Useless for Most Stable Patients. They ’ re Still Widely Used.

Mon, 12 Feb 2018 10:00:14 +0100

Why are so many people paying so much — and putting themselves at risk — for a placebo effect? (Source: NYT Health)



Why Thailand is an Untapped Medtech Opportunity

Mon, 12 Feb 2018 06:08:38 +0100

During the MD&M West Conference and Expo in Anaheim, CA last week, attendees were invited to learn about business and partnering opportunities in the Thai market and network with Thai representatives who support companies in early, mid, and mature stages of growing their Southeast Asian business plans.  As the infographic above indicates, there are several factors driving opportunities for medtech in Thailand. Tanee Sangrat, the consul general of Thailand's consulate in Los Angeles, CA, said there are more than 1,000 public and private hospitals nationwide and many of these hospitals are upgrading and expanding their facilities to offer a broad range of treatments. With about 2 million international patients traveling to Thailand every year for medical procedures, the country is quick...



This UV Lamp Could Prevent the Flu Virus From Spreading in Public Places

Fri, 09 Feb 2018 20:33:52 +0100

Researchers have developed an ultraviolet (UV) lamp that kills the influenza virus but isn’t harmful to human skin or eyes, according to a new study in Scientific Reports. They hope the technology can be commercialized and marketed to prevent the spread of seasonal flu in public places, such as schools, hospitals, and airports. “We’ve known for a century that UV light is extremely efficient at killing microbes, bacteria, and viruses,” says study leader David Brenner, director of the Center for Radiological Research at Columbia University Irving Medical Center. For that reason, UV devices are often used for sterilization — for medical equipment in hospitals, for example, or drinking water for backcountry campers. But conventional germicidal lamps aren’t ...

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#DidYouKnow https://twitter.com/SGottliebFDA/status/961378031020531713   …

Fri, 09 Feb 2018 19:30:04 +0100

#DidYouKnow https://twitter.com/SGottliebFDA/status/961378031020531713 … (Source: Food and Drug Adminstration (FDA): CDRHNew)



Higher performance standards help lower misdiagnoses with antigen-based #flu tests – https://go.usa.gov/xnH8M  

Fri, 09 Feb 2018 18:07:03 +0100

Higher performance standards help lower misdiagnoses with antigen-based #flu tests – https://go.usa.gov/xnH8M  (Source: Food and Drug Adminstration (FDA): CDRHNew)



Appeals court revives lawsuit over death allegedly linked to Zoll ’ s LifeVest

Fri, 09 Feb 2018 16:51:43 +0100

Asahi Kasei (TYO:3407) subsidiary Zoll Medical is facing a revived suit alleging that the company’s LifeVest failed to appropriately shock a patient’s heart, resulting in her death. The case was filed by Dennis Godelia, remaining son of deceased Debra Godelia, who died in 2013 after the LifeVest allegedly did not function correctly during a “defibrillation event,” court documents report. Mr. Godelia claims that the LifeVest made an audible alarm, but did not shock Ms. Godelia, who lost consciousness and died two days later. He proceeded to file a complaint in Florida state court relating to the malfunction, according to court documents. Zoll, after moving the case to federal court, moved to dismiss the case arguing that claims in the case were pre-empted by the Medical D...



Fort Duncan Regional Medical Center Expands Digisonics Cardiovascular Information System with ...

Fri, 09 Feb 2018 12:17:02 +0100

HOUSTON (February 8, 2018)– Fort Duncan Regional Medical Center in Eagle Pass, Texas has expanded the Digisonics Cardiovascular Information System to their cardiac catheterization lab. The Digisonics system provides Fort Duncan Regional Medical Center with a state-of-the-art system for their cardiac patients. Immediate access to critical information and faster turnaround times will provide optimal cardiac care. An interface with the facility’s Merge hemodynamics system provides...This story is related to the following:Medical Equipment& Supplies (Source: Industrial Newsroom - Health, Medical and Dental Supplies)