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MedWorm: Medical Equipment



MedWorm.com provides a medical RSS filtering service. Over 7000 RSS medical sources are combined and output via different filters. This feed contains the latest news and research in Medical Equipment



Last Build Date: Mon, 28 Mar 2016 17:13:28 +0100

 



Intuitive Surgical touts cost study on robot-assisted prostate surgery

Mon, 28 Mar 2016 14:37:16 +0100

This study further demonstrates that hospital administrators need to look beyond visible operating room costs when analyzing the robotic-assisted surgery value proposition,” added chief medical officer Dr. Myriam Curet. “The ability of robotic-assisted surgery to reduce complications and shorten hospital stays, undoubtedly leads to greater value for patients and healthcare providers.” The post Intuitive Surgical touts cost study on robot-assisted prostate surgery appeared first on MassDevice. (Source: Mass Device)

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Glaukos wins Japanese nod for iStent glaucoma device

Mon, 28 Mar 2016 14:10:09 +0100

Glaukos (NYSE:GKOS) said today that the Japanese Ministry of Health, Labor & Welfare approved its iStent device for treating glaucoma. Laguna Hills, Calif.-based Glaukos said the approval covers use of the iStent in conjunction with cataract surgery, making it the 1st within-the-eye micro-invasive glaucoma surgery device to hit the market in Japan. The device is designed to be inserted via a small corneal incision into the Schlemm’s canal to restore the eye’s ability to drain aqueous fluid and relieve intraocular pressure. Glaukos won pre-market approval from the FDA for the iStent in 2012. “The iStent represents an important new option for effectively managing elevated IOP in glaucoma, a disease that is a leading cause of blindness worldwide,” president &am...



BioTelemetry ponies up $16m for VirtualScopics

Mon, 28 Mar 2016 12:37:07 +0100

BioTelemetry (NSDQ:BEAT) said last week that it agreed to pay about $15.5 million to acquire clinical trial imaging provider VirtualScopics (NSDQ:VSCP) with an all-cash tender offer. Terms of the deal for Rochester, N.Y.-based VirtualScopics include a $4.05-per-share tender for roughly 3 million VSCP shares. BioTelemetry, which is based in Malvern, Pa., is also due to offer $336.30 per share for VirtualScopics’ Series A and Series B stock $920.00 per share for VirtualScopics’ Series C-1 stock. The tender offer, slated to launch April 11, is expected to close during the 2nd quarter, BioTelemetry said. That company also agreed to acquire any shares not initially tendered, in a 2nd-step merger at the same share price. “We are excited to further expand our clinical res...



Zimmer Biomet says federal probe to extend past deadline

Mon, 28 Mar 2016 12:10:22 +0100

Zimmer Biomet (NYSE:ZBH) said last week that the U.S. Justice Dept.’s probe into alleged Biomet kickbacks schemes in Brazil and Mexico will extend past the deadline of a deferred prosecution agreement reached in 2012. The DoJ alleged that Biomet and its subsidiaries paid out more than $1.5 million in illegal kickbacks to employees of state-owned health services in Brazil and China. Biomet paid $22 million in March 2012 to settle the case with the Justice Dept. and the U.S. Securities & Exchange Commission. In July 2014, an SEC subpoena prompted Biomet to reveal other alleged improprieties at its operations in Brazil and Mexico. A year ago, Warsaw, Ind.-based Biomet said the DPA would be prolonged until March 26. Zimmer and Biomet merged in June 2015. Zimmer Biomet said M...



Summer 2016 enforcement date set for Chinese medical device clinical trial rules

Mon, 28 Mar 2016 11:00:32 +0100

By Stewart Eisenhart, Emergo Group The China Food and Drug Administration (CFDA) plans to begin enforcing new clinical trial quality management requirements for medical devices starting June 1, 2016. Applicable to medical devices but not IVDs, the new guidelines pertain to all clinical studies for safety and effectiveness of products submitted for CFDA registration. China’s previous rules for clinical trials under the Provision on Medical Device Trials of 2004 will be replaced by these new requirements. The new guidelines (link in Chinese) include the following provisions that China medical device market registrants should be aware of: Sponsors should complete all pre-trial testing such as CFDA registration testing before conducting actual clinical trials; pre-trial test reports should...



Federal Register: Authorization of Emergency Use of an In Vitro Diagnostic Device for Diagnosis of Zika Virus Infection; Availability

Mon, 28 Mar 2016 04:00:00 +0100

The FDA is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for an in vitro diagnostic device for diagnosis of Zika virus infection in response to the Zika virus outbreak in the Americas. FDA issued this Authorization... (Source: Food and Drug Adminstration (FDA): CDRHNew)



Heater-Cooler Devices

Mon, 28 Mar 2016 04:00:00 +0100

Heater-cooler devices are often necessary for use during surgeries to warm or cool patients as part of their care. They are especially important tools for surgeries involving the heart, lungs, esophagus, and other chest organs (cardiothoracic surgeries... (Source: Food and Drug Adminstration (FDA): CDRHNew)



ALD mediated heparin grafting on nitinol for self-expanded carotid stents

Sat, 26 Mar 2016 23:00:00 +0100

In this study, atomic layer deposition (ALD) technology was applied to deposit a layer (10nm) of Al2O3 on Nitinol surface as an intermediate functional layer. The alumina covered surface was then modified with a coupling agent 3-aminopropyltriethoxysilane (APS) and heparin sequentially in order to improve the hemocompatibility of Nitinol stents. The successful graft of APS and heparin onto Nitinol was proven by X-ray photoelectron spectroscopy. Furthermore, the predicted improvement in the biocompatibilities of modified Nitinol was confirmed by water contact angle measurement, protein adsorption, platelet adhesion, and plasma recalcification time determination. The results of hemolysis assay, cell proliferation and cytotoxicity tests revealed that the grafting of heparin on NiTi kept the o...



User involvement in the ergonomic development of a medical instrument: a longitudinal case study.

Sat, 26 Mar 2016 03:10:02 +0100

In this study the focus is on the continuous ergonomic-focused development of a medical instrument that is capable of performing blood group serological tests. Primarily, a medical device must be clinically effective and safe. At the same time it must also meet the needs of its users. This calls for consideration of numerous ergonomic aspects. The development process of the product line in question was supported by a longitudinal series of carefully designed focus groups. Altogether, the 23 focus groups conducted included 245 participants from 72 laboratories. The aim of the empirical research was to collect users' experiences, ideas and needs as inputs for the following phase of the product development process. During the mentioned focus group analyses, around 100 development proposals we...



DoD re-ups Philips contract for $77m

Fri, 25 Mar 2016 22:06:12 +0100

Royal Philips (NYSE:PHG) won a maximum $77 million modification through the U.S. Department of Defense as the 7th year in a possible 9-year contract for medical equipment. The contract positions Philips to supply the DoD with patient monitoring systems, subsystems, accessories, consumables, spare or repair parts and training on the systems, and comes as a fixed-price with economic price adjustment contract. The Army, Navy, Air Force, Marine Corps and federal civilian agencies are included in the contract, with appropriation from the fiscal 2016 to the fiscal 2017 years, according to a DoD press release. Earlier this month, Philips said it won security compliance certification from the DoD for its digital pathology solutions, claiming it is the pathology IT system to win clearance under the...

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Titan Medical updates on offering, looking to raise $10-12 million

Fri, 25 Mar 2016 21:26:51 +0100

Titan Medical (CVE:TMD) said today it filed a prospectus supplement for the offering it announced earlier this week, saying its agent Bloom Burton & Co. is looking to float 14 to 16 million shares to bring in between $10.6 and $12.1 million (CAD $14 – $16 million). Each warrant is exercisable at the price of 92¢ (CDN $1.20) and entitles the holder to acquire 1 common share of stock in Titan Medical for 5 years following the closing, which the company said it expects to happen on or about March 31. Bloom Burton & Co have been granted an over-allotment option at the issued price plus an additional 15¢ (CAD 20¢) per over-allotment warrant, which are exercisable in part or whole any time on the closing date or up to 30 days after, according to an SEC filing. Over-allotment w...



3 US hospitals hit by ransomware

Fri, 25 Mar 2016 20:14:24 +0100

Three U.S. hospitals were hit by “ransomware” this week, bringing down their IT systems, according to a report from NBC News. Methodist Hospital in Ky. and California’s Chino Valley Medical Center and Desert Valley Hospital all fell victim to ransomware, according to NBC news. The 2 California hospitals reported that they were running normally again shortly after the attack. Ransomware is effectively digital extortion – malicious programs that control user devices and files until the user ponies up, usually in the digital currency Bitcoin. “The malware disruption did not impact patient safety or compromise patient records, staff records or patient care,” said Prime Healthcare Management spokesperson Fred Ortega, according to NBC News. Prime Healthcare Management...



CSI reups supply deal with Fresenius

Fri, 25 Mar 2016 19:01:03 +0100

Cardiovascular Systems (NSDQ:CSII) said last week it extended its supply deal with Fresenius (NYSE:FMS) for its ViperSlide lubricant, extending the agreement through April 4, 2021. The extension to the agreement also gives Cardiovascular Systems final purchase rights upon the termination of the agreement or if Fresenius stops production of ViperSlide. St. Paul, Minn.-based Cardiovascular Systems said the extended agreement included an update to the product pricing schedule as well, according to an SEC filing. Earlier this month, Cardiovascular Systems said it agreed to an $8 million settlement with the plaintiff in a False Claims Act lawsuit based on allegations from a former sales rep that the company ran kickbacks and an off-label marketing scheme to boost sales of its orbital arthere...

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MassDevice.com +5 | The top 5 medtech stories for March 25, 2016

Fri, 25 Mar 2016 19:00:09 +0100

Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters.   5. GI Dynamics taps medtech vet Schorer for CEO GI Dynamics said this week that it named a veteran medical device executive, Scott Schorer, to be its new president & CEO effective immediately. Schorer spent the last 6 years as a consultant, advising and helping run companies including stealthy Auris Robotics and Neograft Technologies, and led sales improvement efforts at Medtronic, Zimmer Biome...



Fortimedix seeks FDA clearance for single-port surgery device

Fri, 25 Mar 2016 18:03:22 +0100

Netherlands-based medical device company Fortimedix Surgical said today it submitted an application for FDA 510(k) clearance for its FMX314 single-port surgery device. The company said its FMX314 is the “world’s 1st” single-port surgery solution compatible with standard 15mm laproscopic trocar. The device “closely mimicks” conventional multi-port laparoscopy to allow surgeons to comfortably perform procedural steps, Fortimedix said. “We are very pleased to announce our submission with the FDA, as it represents an important milestone towards market introduction of FMX314 in the United States, which is expected in the fourth quarter of this year,” global business dev veep Marc van de Graaf said in a press release. Fortimedix is a developer of endov...



Patent troll files swath of suits against ortho companies

Fri, 25 Mar 2016 16:29:09 +0100

WiLan company Orthopedic Innovations is looking to bring in damages for infringed intellectual properties, filing 5 separate patent suits against major orthopedic companies last October. The suits are in relation to a patent it holds over “technologies related to a gap checking method and apparatus for shaping a femur preparatory to implanting a knee prosthesis,” which it claims each company infringed upon with a variety of different products. Included in the suit are ConforMIS (NSDQ:CFMS), DePuy Synthes, Stryker (NYSE:SYK), Zimmer Biomet (NYSE:ZBH) and Medacta. Each lawsuit was filed over Orthopedic Innovations Patent No. 6,575,980. In a filing against DePuy Synthes, the company claims that DePuy “designs, manufactures, and sells surgical techniques and products that i...



What Could be the Next Frontier in Wearables?

Fri, 25 Mar 2016 15:47:08 +0100

(Source: MDDI)



FDA Proposes Ban on Powdered Gloves After Years of Review

Fri, 25 Mar 2016 15:01:48 +0100

(Source: MDDI)



Losses widen for DJO Global as it exits the Empi distributorship business

Fri, 25 Mar 2016 14:29:06 +0100

Fourth-quarter and full-year losses widened for DJO Global, as it completed the exit of its Empi orthopedic stimulation business. Losses were -$49.6 million for the 3 months ended Dec. 31, 2015, as sales grew 6.1% to $308.0 million compared with Q4 2014. Full-year losses rose 276.6% to -$340.9 million, on sales growth of 2.4% to $1.11 billion compared with 2014. Adjusted to exclude 1-time and discontinued items from the Empi exit, earnings before interest, taxes, depreciation and amortization were $68.9 million for the 4th quarter and $249.0 million for the full year. “During the 4th quarter of 2015, we completed the wind-down of the Empi business and restated the historical financials to reflect Empi as discontinued operations and are pleased to report a strong quarter and full yea...



So you want to to lead an emerging medtech company? These 17 CEOs have some advice for you

Fri, 25 Mar 2016 14:23:47 +0100

By Amy Siegel, S2N Health The CEOs of emerging med tech companies are among the hardest working people I know. There are a multitude of things to worry about, with several on the edge of cataclysm at any given point – keeping money in the bank, getting the damn technology to work, the FDA, building out the human and capital infrastructure, managing the burn rate, filing IP, gearing up clinical trials, manufacturing, commercialization, engaging KOLs, generating “buzz”, meeting with strategic partners, managing the BOD, and so on. Just writing that sentence exhausted me. For a new CEO of a small med tech company, all this can be quite overwhelming, so I turned to my road-tested CEO clients and friends and asked them a simple question: What’s the single most important piece of adv...

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GI Dynamics taps medtech vet Schorer for CEO | Personnel Moves March 25, 2016

Fri, 25 Mar 2016 13:20:30 +0100

GI Dynamics taps medtech vet Schorer for CEO Troubled GI Dynamics (ASX:GID) said this week that it named a veteran medical device executive, Scott Schorer, to be its new president & CEO effective immediately. Schorer spent the last 6 years as a consultant, advising and helping run companies including stealthy Auris Robotics and Neograft Technologies, and led sales improvement efforts at Medtronic (NYSE:MDT), Zimmer Biomet (NYSE:ZBH), Covidien, Teleflex (NYSE:TFX) and Stryker (NYSE:SYK), according to his LinkedIn profile. He spent a year as Americas president at Systagenix, the wound care business spun out of JNJ in 2009. Schorer was also founder & CEO of Innovative Spinal Technologies for 8 years, before that company declared bankruptcy and was sold to Integra LifeSciences fo...



Report: Olympus hiked the price on ‘scopes during superbug outbreak

Fri, 25 Mar 2016 13:08:08 +0100

Olympus (TYO:7733) reportedly tried to hike the price on the duodenoscopes implicated in superbug outbreaks last year even as the infections were traced back to its own devices. In Seattle, 39 people were infected at the Virginia Mason Medical Center between 2012 and 2014; 11 eventually died. All were critically ill when they were infected, but it was unclear if the bacterial infection contributed to their deaths, Seattle public health officials said at the time. Four patients in March 2015 were infected with bacteria from a contaminated scope and 67 more were at risk at Cedars-Sinai Medical Center in Los Angeles, weeks after UCLA Ronald Reagan hospital reported 8 patients were similarly infected and scores more potentially exposed; 3 of the UCLA patients eventually died. As the outbre...



Goldman Sachs gets in on Chinese cardiac valve maker Venus Medtech

Fri, 25 Mar 2016 12:22:15 +0100

Chinese replacement heart valve maker Venus Medtech said today that it won a $37 million commitment from Goldman Sachs (NYSE:GS). Hangzhou-based Venus said it’s also won backing from Qiming Venture Partners, Sequoia Capital China, and Dinova Venture Capital. The company already has a transcatheter aortic valve replacement on the market in the People’s Republic and said a pulmonary valve is in clinical trials. Venus said its Venus A-Valve is the only TAVR device that meets China Food & Drug Administration requirements. More than 40 patients have been implanted with the Venus P-Valve pulmonary replacement in a global trial, the company said, and a study aimed at winning CE Mark approval in the European Union is slated to start enrolling patient during the 1st half of the...



Exploring better options for ACL repairs

Fri, 25 Mar 2016 11:00:33 +0100

by Lisa Fratt An anterior cruciate ligament (ACL) tear can be a devastating sports injury. Every year, 400,000 people, many of them teen and young adult athletes, sustain ACL injuries or tears. Martha Murray, MD, an orthopedic surgeon at Boston Children’s Hospital, worked with a team of colleagues to create a new procedure known as bridge-enhanced ACL repair (BEAR) that encourages natural healing. Watch this animation to see how it works: Why do surgeons need a better way to repair ACL injuries? The current standard of care, surgical ACL reconstruction, is a good solution. But it is linked with a 20 percent risk of re-tearing the ACL, and many young patients face an increased risk of arthritis. Instead of removing the torn ACL and replacing it with a tendon graft, the BEAR technique us...

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TransEnterix pushes Surgibot decision date back

Fri, 25 Mar 2016 10:51:02 +0100

TransEnterix (NYSE:TRXC) yesterday said the FDA isn’t finished reviewing the 510(k) application for its SurgiBot robot-assisted surgery device, meaning the decision it had expected to come during the 1st quarter isn’t likely to happen until mid-April. Research Triangle Park, N.C.-based TransEnterix claims SurgiBot as the 1st patient-side robotically enhanced laparoscopy platform, designed to be wheeled to a patient’s bedside and operate through a single port. In February the company said it had finalized the clearance application and expected a decision before the end of March. But after a recent FDA update the company said it’s revising its outlook on the timing. “We have been engaged in constructive dialogue with the FDA throughout the entire submission proce...



New regulations for medical devices: Rationale, advances and impact on research and patient care.

Fri, 25 Mar 2016 06:50:02 +0100

Authors: Labek G, Schöffl H, Stoica CI Abstract A series of events relating to inferior medical devices has brought about changes in the legal requirements regarding quality control on the part of regulators. Apart from clinical studies, register and routine data will play an essential role in this context. To ensure adequate use of these data, adapted methodologies are required as register data in fact represent a new scientific entity. For the interpretation of register and routine data several limitations of published data should be taken into account. In many cases essential parameters of study cohorts - such as age, comorbidities, the patients' risk profiles or the hospital profile - are not presented. Required data and evaluation procedures differ significantly, for example,...



Xtant, Vivex ink distribution deal for OsteoVive allograft

Thu, 24 Mar 2016 22:14:50 +0100

Xtant Medical said today it inked a distribution deal with Vivex Biomedical to distribute its OsteoVive cellular bone allograft. The new agreement will allow Xtant to enter the cellular bone graft market which the company said is estimated to be between $252 million in 2015 and $400 million in 2019. “Vivex is enthusiastic about teaming up with Xtant Medical, a leading distributor of biologics products. Working closely with leading biologics distributors like Xtant Medical helps further our mission of enhancing patient care by expanding industry knowledge and capability,” Vivex CEO Tracy Anderson said in a press release. Canadian Xtant Medical said Vivex’s proprietary process preserves cell population including marrow-isolated adult multilineage inducible cells, which th...



LumiThera wins Health Canada nod for photobiomodulation trial

Thu, 24 Mar 2016 21:14:23 +0100

LumiThera said today it won Health Canada approval for its Lightsite clinical trial examining the effect of its non-invasive photobiomodulation treatment in patients with age-related macular degeneration. The Seattle-based company’s study is being sponsored by a grant from the National Institute of Health and the division of the National Eye Institute. “The design of the study is to extend the previous clinical benefits in a double-masked, randomized, sham-controlled, parallel group study to assess the safety and efficacy of PBM in subjects with dry AMD. We believe this study will lay a solid foundation for the LumiThera device as a novel therapeutic approach to treating a very debilitating, degenerative ocular disease,” co-investigator Dr. Sam Markowitz said in prepared...



MassDevice.com +5 | The top 5 medtech stories for March 24, 2016

Thu, 24 Mar 2016 20:00:07 +0100

Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters.   5. InVivo raises $32m, enrolls 7th patient in Inspire study InVivo Therapeutics said today it closed an over-allotment period for a previous round of financing, selling another 560,000 shares and lifting the total raised to $32.2 million, and said yesterday it enrolled a 7th patient in its Inspire study. Cambridge, Mass.-based InVivo floated 3.7 million units at $7.50 per unit in its initial offer...

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Carestream seeks FDA nod for OnSight 3D cone-beam extremities CT imager

Thu, 24 Mar 2016 18:47:10 +0100

Carestream Health said today it filed a 510(k) application with the FDA seeking clearance for its OnSight 3D Extremity System cone-beam based extremity CT imaging device. The Rochester, N.Y.-based company’s system is designed to provide high-quality, low-dose 3D imaging for use by orthopedic and sports medicine practices, hospitals, imaging centers, urgent care facilities and other healthcare providers. “Orthopaedic imaging is a major focus for Carestream because of the prevalence of musculoskeletal conditions among people of all ages. Youth and adults often suffer sports-related injuries to their knees, ankles and feet while older adults experience arthritis, joint instability, meniscus loss and other conditions. Our goal is to offer a compact, affordable imaging system that ...



Baxter wins expanded EU indication for Hemopatch

Thu, 24 Mar 2016 18:11:01 +0100

Baxter (NYSE:BAX) said today it won CE Mark approval in the European Union for an expanded indication for its ready-to-use surgical Hemopatch. The Deerfield, Ill.-based company’s Hemopatch is now cleared for use in closing dural defects including excision, retraction or shrinkage of the dura mater following traumatic injury. The patch is also cleared as a hemostatic device and surgical sealant for procedures where controlling bleeding, body fluid or air leakage is ineffective or impractical. “Hemopatch now has one of the broadest indications available for advanced surgical patches in the European Union. It features innovative technology, works quickly and effectively, and does not require preparation time, which means it is ready whenever it is needed by the surgeon and can be...



Gore launches new type of study for Synecor hernia biomaterial

Thu, 24 Mar 2016 17:40:44 +0100

W.L. Gore & Associates said today it is launching a clinical quality improvement project to study its Synecor biomaterial designed for open, laparoscopic and robotic single-stage hernia repairs. The Synecor biomaterial is comprised of dense monofilament polytetrafluoroethylene macroporous knit to provide strength and reduce bacteria growth, Gore’s Bio-A Web tissue scaffold and a non-porous PGA/TMC film to minimize tissue attachment at the visceral side, the company said. The Flagstaff, Ariz.-based company said it partnered with patient safety organization Surgical Momentum to facilitate the study. “We embarked on a CQI project in place of Gore’s historical approach to clinical studies to enable us to include a more representative patient sample and adapt to clinical findings ...



MicroPort® Signs Cooperation Agreement with Beijing Weimai Medical Device

Thu, 24 Mar 2016 17:13:30 +0100

(Source: Microport News Release)

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An Introduction To Manufacturing Execution Systems For The Medical Device Industry

Thu, 24 Mar 2016 16:51:28 +0100

Manufacturing Execution System (MES) solutions have the potential to generate efficiencies, improve productivity, and simplify compliance within the medical device manufacturing industry. Used to manage production activities, this class of software typically provides the ability to schedule activity, deliver instructions to operators, synchronize manual activities with automated processes, and integrate with manufacturing computer systems to enable quality control, deviation management and effective enterprise resource planning (ERP), equipment management, and the documenting of floor activities for monitoring and reporting purposes. (Source: Medical Design Online News)



Besides Reimbursement, What's Blocking CardioMEMS' Adoption?

Thu, 24 Mar 2016 16:36:51 +0100

(Source: MDDI)



Sanuwave trial misses efficacy endpoint but shows superiority at 24 weeks

Thu, 24 Mar 2016 16:25:36 +0100

Sanuwave Health (OTC:SNWV) today released 24-week data from the pivotal trial of its dermaPace, saying it missed its 12-week primary efficacy endpoint but returned a greater reduction in wound size and lowered amounts of subjects with increased wound size compared to the control treatment at 24 weeks. Data came from 2 24-week studies at 39 centers across the U.S., studying a total of 336 subjects treated with either the dermaPace and conventional therapy or sham dermaPace and conventional therapy, Alpharetta, Ga.-based Sanuwave said. The primary efficacy endpoint for the studies were the incidence of complete wound closure at 12 weeks post-initial treatment with dermaPace or the sham dermaPace. The primary safety endpoint of the trial was the overall rate of adverse events throughout 24...



What do medical sales reps like most about their jobs?

Thu, 24 Mar 2016 15:55:08 +0100

Money and satisfaction are highly correlated Although medical sales reps report that relationships with patients and providers are the things they like best about their jobs, those who say they’re least satisfied with their jobs are also the ones who make the least, according to a survey of more than 1,400 reps. The post What do medical sales reps like most about their jobs? appeared first on MassDevice. (Source: Mass Device)

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Bis‐(2‐ethylhexyl) Phthalate (DEHP) Increases Insulin Expression and Lipid Levels in Drosophila melanogaster

Thu, 24 Mar 2016 15:26:32 +0100

This article is protected by copyright. All rights reserved. (Source: Basic and Clinical Pharmacology and Toxicology)



InVivo raises $32m, enrolls 7th patient in Inspire study

Thu, 24 Mar 2016 15:23:11 +0100

InVivo Therapeutics (NSDQ:NVIV) said today it closed an over-allotment period for a previous round of financing, selling another 560,000 shares and lifting the total raised to $32.2 million, and said yesterday it enrolled a 7th patient in its Inspire study. Cambridge, Mass.-based InVivo floated 3.7 million units at $7.50 per unit in its initial offering which closed March 18, bringing in $28 million. Each unit of the $7.50-per-share offering consists of a share of common stock and half of a 5-year warrant with an exercise price of $10, the company said. Raymond James & Associates acted as the sole book-runner for the offering, with Ladenburg Thalmann and Cantor Fitzgerald & Co. as co-managers. Funding from the round will be used to fund ongoing clinical trials and for general cor...



Survey: Medical sales reps like the money, not their bosses

Thu, 24 Mar 2016 15:10:40 +0100

Although medical sales reps report that relationships with patients and providers are the things they like best about their jobs, those who say they’re least satisfied with their jobs are also the ones who make the least, according to a survey of more than 1,400 reps. The MedReps.com survey also reveals what medical sales reps like least about their jobs: The boss. Some 21% of respondents list “relationships with provides and patients” as the thing they like most about their jobs; only 6%  said “money.” But the average income for reps who say they’re “very satisfied” is higher than the average for reps who are “somewhat satisfied.” And reps who are “very unsatisfied” also report the lowest average income: Medical ...



OEM Tympanic Thermometer: Genius™ 2

Thu, 24 Mar 2016 13:47:03 +0100

Medtronic offers the Genius™ 2 OEM tethered OEM tympanic thermometer designed specifically for OEM integration. A developer’s kit contains all of the vital information needed for your company to facilitate integration of the Genius™ 2 Tethered OEM Tympanic Thermometer into your multi-parameter device. (Source: Medical Design Online Products)



Have a problem? Contact the new ombudsman in the office of regulatory affairs

Thu, 24 Mar 2016 11:00:47 +0100

By: Melinda K. Plaisier Whether we are inspecting your facilities, sampling your products, or conducting investigations, the primary goal of FDA’s Office of Regulatory Affairs (ORA) is to protect the public. But I understand the impact our actions can have on you, so I am committed to making ORA’s processes as transparent as possible and quickly addressing problems you may encounter. That’s why I’m happy to announce a new resource: an ORA ombudsman who can help you with unresolved concerns. While you may continue to bring issues to my staff, Ombudsman Jessica Zeller is dedicated solely to helping you with assessing and resolving problems. Jessica, who has worked in both industry and government, understands that FDA’s perspective is often different from that of industry and other ...

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Frazier Healthcare raises $525m fund

Thu, 24 Mar 2016 10:30:41 +0100

Private equity shop Frazier Healthcare Partners said yesterday that it raised a $525 million fund to invest in small healthcare companies. The Seattle-based company, which has more than $2 billion in assets under management, said the subscribers include existing and new limited partners, which represent some endowments, public and private pension funds and financial institutions. The new fund is the firm’s 1st to focus exclusively on profitable, lower-middle-market companies, Frazier said. “The fund will leverage our broad network and deep knowledge of the space to identify and acquire rapidly growing, profitable healthcare companies,” managing general partner Nader Naini said. “We are appreciative of the continued support from our existing limited partners and p...



Meeting Growing Asia-Pacific Demand For Medical Technology

Thu, 24 Mar 2016 10:21:01 +0100

There’s a need for better access to medical technology in the region — a forward-looking approach will help companies reach more patients. (Source: Medical Design Online News)



Capsugel said to explore sale, IPO

Thu, 24 Mar 2016 10:19:16 +0100

Capsugel‘s private equity owner is said to be exploring a sale or initial public offering for the Pfizer (NYSE:PFE) spinout. A deal could value Capsugel, which makes hard capsules and drug delivery products, at more than $5 billion, Reuters reported, citing “people familiar with the matter.” Private equity shop KKR & Co. (NYSE:KKR) paid $2.38 billion for Capsugel in April 2011. Morristown, N.J.-based Capsugel’s suitors include 3M Cos. (NYSE:MMM), Danaher (NYSE:DHR), Becton Dickinson & Co. (NYSE:BDX), Thermo Fisher (NYSE:TMO), Bayer (ETR:BAYN) and Catalent (NYSE:CTLT), the sources told Reuters. The sources asked not to be identified because the sale process is confidential. KKR and 3M declined to comment, while representatives of Capsugel, Danaher, B...



Xeltis wins FDA nod for bioresorbable pulmonary valve

Thu, 24 Mar 2016 10:02:01 +0100

Xeltis said yesterday that the FDA designated the bioresorbable replacement pulmonary valve it’s developing as a humanitarian use device, granted for device designed to treat rare diseases. The Swiss medical device company’s technology is designed to promote endogenous tissue restoration using polymers structured as a resorbable “porous matrix.” The aim is to gradually replace the polymer structure with naturally regrown tissue; CEO Laurent Grandidier told MassDevice.com last year that the company is also looking at the aortic valve replacement and vascular markets. Xeltis hopes to bring a pulmonary valve to the market by the end of 2018, Grandidier told us. “FDA HUD designation represents an important step for Xeltis and may help expedite the time when bi...



J&J Continues Move from "Disease Care To HealthCare"

Thu, 24 Mar 2016 08:17:59 +0100

Johnson & Johnson (J&J) subsidiary Janssen has announced two new projects as part of its Disease Interception Accelerator (DIA), a program aiming to develop innovative approaches to disease prediction and prevention. The latest projects will seek to identify biomarkers for chronic obstructive pulmonary disease (COPD) and gestational diabetes mellitus (GDM) to create diagnostics that pinpoint these conditions early in their development. (Source: Medical Design Online News)



Apple Unveils CareKit Platform For Health Management

Thu, 24 Mar 2016 08:07:17 +0100

Apple Inc. announced CareKit, a new open-source software platform that will let developers create health monitoring apps for users of Apple devices. Due out in April, it's similar to ResearchKit, a framework launched by Apple last year meant to provide user health data for research institutions to conduct large-scale studies. (Source: Medical Design Online News)



Microsoft's Xbox Kinect Breathes New Life Into Respiratory Assessment

Thu, 24 Mar 2016 04:30:55 +0100

Xbox Kinects could be used in the future to assess the health of patients with conditions such as cystic fibrosis. (Source: Medical Design Online News)



Wireless, Handheld Ultrasound For iOS And Android Debuts

Thu, 24 Mar 2016 04:18:39 +0100

Clarius Mobile Health is showcasing the world's first handheld ultrasound scanner with a mobile application for iOS and Android smart devices at the American Institute of Ultrasound in Medicine Conference inNew York March 18-21, 2016. (Source: Medical Design Online News)



Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance on Reagents for Detection of Specific Novel Influenza A Viruses

Thu, 24 Mar 2016 04:00:00 +0100

The FDA is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. (Source: Food and Drug Adminstration (FDA): CDRHNew)

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Federal Register: Medical Devices; Exemption From Premarket Notification: Method, Metallic Reduction, Glucose (Urinary, Non-Quantitative) Test System in a Reagent Tablet Format

Thu, 24 Mar 2016 04:00:00 +0100

The FDA is announcing that it has received a petition requesting exemption from the premarket notification requirements for a method, metallic reduction, glucose (urinary, non-quantitative) test system in a reagent tablet format that is intended to mea... (Source: Food and Drug Adminstration (FDA): CDRHNew)



EYE-SYNC Device That Assesses Abnormal Eye Movement, A Common Deficit After Concussion, Gains FDA Clearance

Thu, 24 Mar 2016 03:54:03 +0100

SyncThink, a world leader in neuro-technology with foundational intellectual property in eye tracking metrics and devices, announces today the FDA clearance for its first medical device -- EYE-SYNC. (Source: Medical Design Online News)



Plasma functionalization of polycarbonaturethane to improve endothelialization--Effect of shear stress as a critical factor for biocompatibility control

Wed, 23 Mar 2016 23:00:00 +0100

Medical devices made of polycarbonaturethane (PCU) combine excellent mechanical properties and little biological degradation, but restricted hemocompatibility. Modifications of PCU might reduce platelet adhesion and promote stable endothelialization. PCU was modified using gas plasma treatment, binding of hydrogels, and coupling of cell-active molecules (modified heparin, anti-thrombin III (ATIII), argatroban, fibronectin, laminin-nonapeptide, peptides with integrin-binding arginine-glycine-aspartic acid (RGD) motif). Biocompatibility was verified with static and dynamic cell culture techniques. Blinded analysis focused on improvement in endothelial cell (EC) adhesion/proliferation, anti-thrombogenicity, reproducible manufacturing process, and shear stress tolerance of ECs. EC adhesion and...

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Limitations of Murine Models for Assessment of Antibody-Mediated Therapies or Vaccine Candidates against Staphylococcus epidermidis Bloodstream Infection [Bacterial Infections]

Wed, 23 Mar 2016 23:00:00 +0100

In conclusion, these data suggest that S. epidermidis bloodstream infection is cleared in a highly efficient manner that is mediated by both TLR2-dependent and -independent innate immune mechanisms. The inability to establish a persistent infection in mice, even in immunocompromised animals, rendered these murine models unsuitable for meaningful assessment of antibody-mediated therapies or vaccine candidates. (Source: Infection and Immunity)



Missed opportunities to avoid painful shocks at the end of life

Wed, 23 Mar 2016 22:55:51 +0100

Many patients who have a common medical device known as an implantable cardioverter defibrillator (ICD) are unaware that the device can be deactivated to prevent painful shocks in their final days of life. (Source: ScienceDaily Headlines)



Amniox Medical touts foot ulcer study data

Wed, 23 Mar 2016 22:33:51 +0100

Amniox Medical today released results from a retrospective study of its Neox wound allograft in treating chronic diabetic foot ulcers touting an 87% rate of healing in patients treated with the allograft. Findings from the study were presented at Superbones Superwounds East 2016 in Teanack, N.J. last week. “These findings are quite positive for the application of umbilical cord allograft for diabetic foot ulcers. A close review of this data in comparison to other published studies also suggests more frequent applications most likely translates to faster healing, even considering larger initial wound size. High levels of the HC-HA/PTX3 protein complex in the umbilical cord appear to play a central role in successful healing in these cases. The tissue’s demonstrated effectiveness and...



Changes

Wed, 23 Mar 2016 22:13:07 +0100

No abstract available (Source: Journal of Clinical Engineering)



Handheld Device, App Developed To Help Diagnose Lipoedema

Wed, 23 Mar 2016 22:13:07 +0100

No abstract available (Source: Journal of Clinical Engineering)

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Food and Drug Administration Approves Panoply of Medical Devices, Issues Slew of Regulatory Actions

Wed, 23 Mar 2016 22:13:07 +0100

No abstract available (Source: Journal of Clinical Engineering)



Risk Management and Safety

Wed, 23 Mar 2016 22:13:07 +0100

No abstract available (Source: Journal of Clinical Engineering)



What Do Clinical Engineers Do as Medical Devices Enter New Digital Age?

Wed, 23 Mar 2016 22:13:07 +0100

No abstract available (Source: Journal of Clinical Engineering)



The Innovation Institute Adds MultiMedical Systems to Portfolio of Healthcare Service Providers

Wed, 23 Mar 2016 22:13:07 +0100

No abstract available (Source: Journal of Clinical Engineering)



Wearable Device Can Reduce Lethal Blood Clots

Wed, 23 Mar 2016 22:13:07 +0100

No abstract available (Source: Journal of Clinical Engineering)



American College of Clinical Engineering

Wed, 23 Mar 2016 22:13:07 +0100

No abstract available (Source: Journal of Clinical Engineering)



Association for the Advancement of Medical Instrumentation

Wed, 23 Mar 2016 22:13:07 +0100

No abstract available (Source: Journal of Clinical Engineering)



Quantitative Risk Management for In Vitro Diagnostic Products

Wed, 23 Mar 2016 22:13:07 +0100

This article proposes an RM process that is quantitative and measures the effectiveness of the risk process against product performance. (Source: Journal of Clinical Engineering)

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Classification of Brainstem Auditory Evoked Potentials Using Artificial Neural Network Based on Time and Frequency Domain Features

Wed, 23 Mar 2016 22:13:07 +0100

This article presents a novel technique of automated classification of brainstem auditory evoked potentials (BAEPs). Brainstem auditory evoked potentials are the evoked potentials used to measure the brain activity that occur in response to the auditory stimulus to the ear and to record the response by placing electrodes on the surface of the scalp. Brainstem auditory evoked potentials reflect neuronal activity in the auditory nerve pathway from the cochlea to the auditory cortex and are used in the diagnosis of neurological diseases leading to hearing loss. In the proposed automated system, the features of BAEPs are extracted in time domain based on latency, and in frequency domain, using fast Fourier transform and discrete wavelet transform. The features extracted from BAEPs are used as ...



Adverse Event Triggered Event Reporting for Devices: Report of a Food and Drug Administration–Supported Feasibility Pilot of Automated Adverse Event Reporting

Wed, 23 Mar 2016 22:13:07 +0100

The objective of this study is to test the feasibility of using ASTER-D to report medical device AEs. This was a cooperative effort of Outcome Sciences, FDA, and Mercy Health. The ASTER-D system enables a new functionality within the electronic health record for initiating AE reports from triggering events with prepopulated patient- and incident-specific data and minimal disruption to clinician workflow. The ASTER-D system employs health information exchange principles to automate medical device safety reporting and create a “safety information exchange” that allows safety information collected by various organizations to be available to others to facilitate postmarket surveillance. Mercy implemented ASTER-D for AEs related to coronary stents occurring in its cardiac catheterization la...



Using Computational Classifiers to Detect Chronic Alcoholism

Wed, 23 Mar 2016 22:13:07 +0100

Addiction to alcohol is one of the commonest problems in human society. The tribes of the Jharkhand state of India are also generally addicted to a homemade alcohol Mahuwa, fermented from the flower of Madura longifolia. In the present work, the effects of Mahuwa on the cerebral cortex of the brain are evaluated. The digital brain signals or electroencephalogram (EEG) was recorded from frontal, central, and parietal cortices of the brain, and the features for classification were extracted with both time and frequency domain tools: the third-order nonautoregressive method and power spectral density, respectively. The dimensions of these features were further reduced by using linear discriminant analysis before the identification of alcoholic EEG data with the help of support vector machine ...



Reducing Electrosurgical Burns Through Collaboration Between Clinical Staff and Clinical Engineers

Wed, 23 Mar 2016 22:13:07 +0100

As stewards of medical technology in healthcare delivery, clinical engineers can play an important role in helping clinical staff reduce patient risks of electrosurgical burns. With an understanding of the major mechanisms of electrosurgical devices and various clinical situations of electrosurgical burns, clinical engineers can help cultivate a safer electrosurgical environment through collaboration with clinical staff for effective implementation and management of electrosurgical technology. (Source: Journal of Clinical Engineering)

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A Computer-Aided Diagnosis System for the Detection and Classification of Breast Cancer

Wed, 23 Mar 2016 22:13:07 +0100

This study is implemented using MATLAB software. A Graphical User Interface is designed for the implemented algorithm. Results demonstrated that the proposed methodologies have high potential localizing, detecting, and classifying the breast tumor. The system was able to achieve an accuracy of 88% sensitivity, 72% specificity, an Az value of 0.84, and an overall classification accuracy of 80%. The created systems have therefore proved to effectively discriminate between malignant and benign tumors with an effective level of precision. (Source: Journal of Clinical Engineering)



Neonatal Transport Incubator: Vibration Identification, Ranking, and Attenuation—A Novel Approach to Patient Tray Stabilization

Wed, 23 Mar 2016 22:13:07 +0100

The Texas Children’s Hospital (TCH) Biomedical Engineering Department, in conjunction with the Kangaroo Crew and Nursing departments, strive to increase the quality of patient care through research and innovation. The TCH has been engaged in a comprehensive research campaign to characterize the type of mechanical forces that the neonate would experience in a transport incubator on a typical neonatal transport. After several years of measuring vibration forces during in-hospital (J Clin Eng. 2008:74-77), ambulance, and air transportation modalities, it was determined that our core need was to conduct forced vibration tests of the transport incubator in a simulated environment using a large shaker table (Space Act Agreement no. SAA-EA-09-006 with TCH Biomedical Engineering, TCH contract no...



Medical Device Connectivity Case Study

Wed, 23 Mar 2016 22:13:07 +0100

No abstract available (Source: Journal of Clinical Engineering)



Intersect ENT wins expanded FDA approval for Propel Mini

Wed, 23 Mar 2016 21:29:58 +0100

Intersect ENT (NSDQ:XENT) said today it won FDA premarket approval for an expanded indication for its Propel mini steroid releasing sinus implant designed to treat patients undergoing frontal sinus surgery. The expanded indication from the Menlo Park, Calif.-based company will allow the company to market the placement of the Propel mini in the frontal sinuses behind the eyebrows. Previous indication only allowed for placement in the ethmoid sinuses behind the bridge of the nose. “This approval is significant for patients with frontal sinus disease, which has traditionally been difficult to treat and greatly impacts quality of life, with debilitating symptoms including severe headaches. We are grateful to the patients who participated in the PROGRESS trial. The clinical data from the ...

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ACell wins 510(k) for modified MicroMatrix

Wed, 23 Mar 2016 20:56:00 +0100

ACell said today it won additional FDA 510(k) clearance for its MicroMatrix device allowing the use of the device in conjunction with Cytal wound matrix or Cytal burn matrix devices. The MicroMatrix is a micronized particulate form of ACell’s Urinary Bladder Matrix designed to cover the wound bed in normal or irregular wounds, the Columbia, Md.-based company said. “This is the 3rd major FDA clearance over the last year for ACell, and we have a pipeline of new regulatory and clinical applications planned, as we continue commercializing expanded uses of our UBM technology,” CEO Patrick McBrayer said in a press release. The company said the clearance also allows for the modification of the MicroMatrix instructions for use to include the option to hydrate the device in ster...



MassDevice.com +5 | The top 5 medtech stories for March 23, 2016

Wed, 23 Mar 2016 20:00:47 +0100

Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters.   5. Stryker launches $5m SurgiCount liability plan for retained sponges Stryker said today it is launching the SurgiCount Promise risk-sharing program, offering up to $5 million in product-liability costs to hospitals which use its SurgiCount safety-sponge system. The system is designed to eliminate retained sponges, which can cause severe injuries in patients and cost the healthcare system $2.4 bi...



FDA OKs improved MarginProbe device from Dune Medical

Wed, 23 Mar 2016 19:32:40 +0100

Dune Medical Devices said today it won pre-market approval from the FDA for modifications to its MarginProbe breast cancer surgical device designed for real-time detection of cancer in breast conserving surgeries. Modifications to the Paoli, Penn.-based company’s device were made to conform to recent changes in the European Union’s Restriction of Hazardous Substances requirements, Dune Medical said. The company said it expects the U.S. to adopt similar requirements in the future. “We are continuing to listen to our customers by investing in technology to enhance MarginProbe. Once completed, these changes will enable Dune Medical Device to continue to develop products that will improve the standard of care in breast conserving surgery and allow physicians and patients to ...



Henry Schein expands footprint in Japan with J. Morita stake

Wed, 23 Mar 2016 18:27:41 +0100

Henry Schein (NSDQ:HSIC) said it’s expanding its footprint in the Japanese dental market by buying a 50% stake in a subsidiary of J. Morita Corp. for an undisclosed amount. Melville, N.Y.-based Schein said the deal is for half of One Piece Corp., which has 8 dental dealerships in Japan and booked sales of roughly $125 million last year. Schein said it 1st entered Japan with the October 2014 acquisition of Iwase Dental Supply; former managing director Kenichiro “Ken” Iwase is due to lead the expanded Schein operation in there, the company said. “Japan represents an exciting strategic opportunity for Henry Schein,” chairman & CEO Stanley Bergman said in prepared remarks. “While Iwase Dental serves customers in the greater Tokyo area, the One Piec...



Australian ImpediMed raises $56m in private placement

Wed, 23 Mar 2016 18:06:02 +0100

Australian medtech developer ImpediMed said yesterday it closed a $56.6 million (AUD $75.1 million) private placement financing round. The company develops and distributes medical devices which use bioimpedance spectroscopy to provide non-invasive monitoring of fluid status in patients. “We would like to thank our new and existing shareholders for their ongoing support of the company. This capital raise further strengthens our balance sheet, and places the company in a strong position as we continue the commercial rollout of L-Dex in the United States, and advance our bioimpedance spectroscopy (BIS) technology applications and clinical trials for the chronic heart failure market,” CEO Richard Carreon said in a press release. Funds from the round are slated to expand sales and...



FDA clears Stimwave’s StimQ wireless chronic pain stimulator

Wed, 23 Mar 2016 17:46:23 +0100

Stimwave Technologies said today that it’s putting its StimQ peripheral nerve stimulator on the U.S. market after winning pre-market approval from the FDA earlier this month. The StimQ device is designed to treat severe, intractable chronic pain in peripheral nerves, according to Ft. Lauderdale-based-based Stimwave. The tiny device, which is less than 5% of the size of standard implantable pain devices, can be implanted via a needle-sized cannula next the affected nerves, the company said. StimQ is powered by the same wearable patch technology that powers the Freedom-8A spinal cord stimulator, which won an FDA nod in December 2015, Stimwave said. “Thanks to our revolutionary wireless device, we are the only neuromodulation company cleared by the FDA to help patients with redu...



Tissue Engineering Market to be Worth $11.5 billion by 2022

Wed, 23 Mar 2016 17:29:57 +0100

(Source: MDDI)

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FDA warns Terumo over vascular sheath

Wed, 23 Mar 2016 17:24:51 +0100

The FDA last week sent a warning letter to Terumo Corp. (TYO:4543) over issues with the manufacturing and quality control of its Destination Guiding vascular sheaths. The agency warned the company over issues with the manufacturing, packing, storage and installation at the facility that produces its Destination sheaths, referencing failures around design and conformity. The letter came based on an inspection in October last year, which the agency said Terumo had already responded to several times. However, the FDA said it still found inadequacies in the company’s responses. The FDA referenced 7 inadequacies from Terumo in total, all centering around overseeing conformity in products, establishing design verification and validation and monitoring during manufacturing. In referencing a fai...



Philips Respironics settles kickbacks case for $35m

Wed, 23 Mar 2016 17:06:37 +0100

The Respironics division at Philips (NYSE:PHG) agreed to pay $34.8 million to settle U.S. Justice Dept. claims that it paid kickbacks in the form of free call center services to induce suppliers into buying its sleep apnea masks. Today’s settlement resolves a whistleblower lawsuit filed by South Carolina pharmacist Dr. Gibran Ameer, who worked for medical equipment suppliers that bought the Respironics masks. Federal prosecutors said Respironics violated the federal False Claims Act with its “Fit for Life” program from April 2012 to November 2015, provided to suppliers so long as their patients used its masks. “Americans deserve to know that when they are prescribed a device to treat a serious health care problem, the supplier’s judgment has not been co...



Stryker launches $5m SurgiCount liability plan for retained sponges

Wed, 23 Mar 2016 16:20:12 +0100

Stryker (NYSE:SYK) said today it is launching the SurgiCount Promise risk-sharing program, offering up to $5 million in product-liability costs to hospitals which use its SurgiCount safety-sponge system. The system is designed to eliminate retained sponges, which can cause severe injuries in patients and cost the healthcare system $2.4 billion on average every year, according to Stryker. “This is one of the few places in any industry where manual count is the only method,” Stryker Surgicount director Nate Miersma told MassDevice.com in an interview. The SurgiCount system is designed to track each sponge individually to eliminate any chance of retained sponges, and will now come with $5 million in product liability indemnification and a rebate for the cost of implementing the ...

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Lose the Pile of Batteries! Hearing Aids Get New Rechargeable Option

Wed, 23 Mar 2016 16:13:08 +0100

(Source: MDDI)



NSF Health Sciences, Pharma Biotech-Consulting, Auditing, Testing, Training and Regulatory Support

Wed, 23 Mar 2016 14:33:00 +0100

NSF International Health Sciences Division provides an extensive range of quality services to the pharmaceutical, biotech and medical device industries. (Source: Pharmaceutical Technology)



FDA Seeks To Ban Most Powdered Medical Gloves

Wed, 23 Mar 2016 14:21:39 +0100

The U.S. Food and Drug Administration (FDA) is proposing to ban powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s glove, due to mounting evidence that powder can cause harm. (Source: Medical Design Online News)



Trial kicks off in 10-year-old Abbott stent case

Wed, 23 Mar 2016 13:32:13 +0100

A 10-year-old whistleblower lawsuit filed by a former Abbott (NYSE:ABT) sales rep, over the alleged off-label marketing of biliary stents, finally went to trial in Dallas yesterday. Plaintiff Kevin Colquitt, a former rep for Abbott’s Guidant division, sued Abbott, Johnson & Johnson (NYSE:JNJ) and Boston Scientific (NYSE:BSX) in 2006, claiming that they marketed the use of biliary stents to treat peripheral artery disease. (The magistrate overseeing the lawsuit, Judge Barbara Lynn of the U.S. District Court for Northern Texas, later let J&J and Boston Scientific off the hook.) Abbott acquired Guidant’s stents business in 2006 as part of Guidant’s acquisition by Boston Scientific. Colquitt’s qui tam lawsuit alleges that Abbott defrauded Medicare wh...



M3 medical portal, backed by Sony, gets into medical devices with MedTecHeart investment

Wed, 23 Mar 2016 11:09:31 +0100

M3 Inc., a Sony (TYO:6758)-backed Japanese web portal for physicians, is getting into the medical device game with an investment in MedTecHeart and its outside-the-body cardiac assist device. A joint venture between Tokyo Medical & Dental University and the Tokyo Institute of Technology, MedTecHeart’s extracorporeal ventricular assist device is designed to treat patients with heart failure using a magnetically levitated pump. “Practical realization of this device will contribute to saving the lives of and improving treatment as well as the quality of life for patients with severe cardiac dysfunction,” M3 said in a press release. Sony owns a 40% stake in the firm. The investment is part of M3’s new “seeds rocket” business “to boost promising ...

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How to win early investors: Tips for gauging startup resources

Wed, 23 Mar 2016 11:00:51 +0100

How do you get companies or investors to support your project in a startup world where “many are called, few are chosen?” Vector attended a panel last week on the subject, moderated by Ryan Dietz, Senior Licensing Manager at Boston Children’s Hospital’s Technology and Innovation Development Office (TIDO). The panelists were: Tom Luby, PhD, Senior Director, New Ventures, Johnson & Johnson Innovation, Boston Carl Berke, PhD, Co-Founder and Managing Director, Mass Medical Angels; Partner, Partners Innovation Fund (part of Partners HealthCare); Diagnostic Technologies Representative, Boston Biomedical Innovation Center (B-BIC) Kevin Bitterman, PhD, Partner, Polaris Partners Below is their distilled advice for physicians and scientists seeking to commercialize a drug discovery, de...



Boston Scientific Launches AXIOS Stent And Delivery System From Xlumena Acquisition

Wed, 23 Mar 2016 10:46:22 +0100

Boston Scientific announced the launch of an endoscopic system indicated for the minimally invasive treatment of complications from pancreatitis. The AXIOS Stent and Electrocautery Enhanced Delivery System (AXIOS) were developed by Xlumena, a startup acquired by Boston Scientific last year to expand its portfolio of endoscopic offerings. (Source: Medical Design Online News)



Nigeria: Nigerian Doctors Abroad Give Conditions to Return Home

Wed, 23 Mar 2016 08:14:05 +0100

[Vanguard] Abuja -Physicians of Nigerian origin practicing abroad have given the Federal Government some conditions under which they can transfer their services home, among which include granting them low interest loans and high reduction in tariff of transportation of medical equipment into the country. (Source: AllAfrica News: Health and Medicine)



03.24.16 -- J&J Targets 6 Device Segments | A Chat With AdvaMed's New CEO

Wed, 23 Mar 2016 00:24:08 +0100

03/24/16Med Device Online Newsletter (Source: Medical Design Online Newsletters)

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Money-Back Guarantee in Medical Devices?! Stryker Says Yessir

Tue, 22 Mar 2016 23:07:38 +0100

(Source: MDDI)



Robust breathing signal extraction from cone beam CT projections based on adaptive and global optimization techniques.

Tue, 22 Mar 2016 23:00:00 +0100

We present a study of extracting respiratory signals from cone beam computed tomography (CBCT) projections within the framework of the Amsterdam Shroud (AS) technique. Acquired prior to the radiotherapy treatment, CBCT projections were preprocessed for contrast enhancement by converting the original intensity images to attenuation images with which the AS image was created. An adaptive robust z-normalization filtering was applied to further augment the weak oscillating structures locally. From the enhanced AS image, the respiratory signal was extracted using a two-step optimization approach to effectively reveal the large-scale regularity of the breathing signals. CBCT projection images from five patients acquired with the Varian Onboard Imager on the Clinac iX System Linear Accelerator (V...



Sanuwave Health brings in $1.5m for dermaPACE

Tue, 22 Mar 2016 21:44:37 +0100

Sanuwave Health (OTC:SNWV) said Monday it closed a $1.5 million round of equity financing to help support the FDA submission of Phase III clinical trial data to support the clearance of its dermaPACE device designed for treating diabetic foot ulcers. The company said it expects to close another round with an additional amount under the same terms by March 31. “With the support from new investors and continued support from existing shareholders and our entire staff, we have improved our balance sheet. This funding increases our financial stability and sets up a clear path towards obtaining FDA approval for our dermaPACE product. These additional financial resources should provide us with the financial flexibility to continue our operations as we prepare our FDA filing and prepare to ...

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Endeavour Vision shifts focus to medtech with new $275m fund

Tue, 22 Mar 2016 20:27:10 +0100

Healthcare investor Endeavour Vision said today it it will shift its focus to medtech after raising $275 million (€250 million) in committed capital for its Endeavour Medtech Growth LP fund. The firm said the fund was largely oversubscribed and reached its hard cap to close well above its $168.3 million (€150 million) target, saying the fund is the largest of its kind dedicated to medtech in Europe. “The medtech sector is evolving rapidly and presents very clear opportunities as we see life sciences and information technology converging in an incredible fashion. This successful fund raising is a strong endorsement of the team’s solid track record and capabilities, as well as its strategy,” Endeavour Vision managing partner Bernard Vogel said in a press release. The compan...



MassDevice.com +5 | The top 5 medtech stories for March 22, 2016

Tue, 22 Mar 2016 20:00:51 +0100

Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters.   5. DeviceTalks Podcast: Cohera Medical CEO Patrick Daly Before Patrick Daly was tapped as chairman of AdvaMed’s Accel unit, which represents emerging medical device companies, the CEO of Cohera Medical sat down with MassDevice.com Executive Editor Brad Perriello at DeviceTalks Raleigh. Daly, who founded the absorbable surgical adhesives and sealants company in 2006, has led 4 funding rounds tota...



Dozens sue Bayer over Essure permanent contraceptive implants

Tue, 22 Mar 2016 19:28:34 +0100

Over 30 women are suing Bayer (ETR:BAYN) over injuries related to its Essure permanent birth control device, claiming the device led to severe health problems including abdominal cramping, migraines and abnormal menstrual bleeding, according to a law firm’s press release.. The lawsuit was filed last Thursday in the Circuit Court of St. Louis, according to the law firms representing the women in the case, who claim they have suffered serious and permanent injuries as a result of using the Essure device. “Bayer purposefully deceived not only the FDA, but our nation’s physicians and ultimately their patients who entrusted their lives, health and well-being on the promise of a safe, effective product. Not only do these women—our friends, wives, coworkers and neighbors—dese...