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Preview: MedWorm: High Intensity Focused Ultrasound Therapy

MedWorm: High Intensity Focused Ultrasound Therapy 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 High Intensity Focused Ultrasound Therapy



Last Build Date: Fri, 06 Apr 2018 14:45:45 +0100

 



SonaCare HIFU prostate registry reaches milestone

Thu, 05 Apr 2018 16:52:25 +0100

High-intensity focused ultrasound (HIFU) developer SonaCare Medical said it...Read more on AuntMinnie.comRelated Reading: SonaCare highlights Medicare payment hike for HIFU SonaCare points to new Medicare HIFU reimbursement code SonaCare debuts international HIFU prostate registry New HIFU center launches in Ohio SonaCare, Invivo team up for HIFU ablation tracking (Source: AuntMinnie.com Headlines)

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HIFU Doc Arrested Again, This Time for Fraud HIFU Doc Arrested Again, This Time for Fraud

Wed, 14 Mar 2018 10:57:59 +0100

This year, Ronald Wheeler, MD, is accused of scheming to defraud a man out of nearly $50,000 for a prostate cancer treatment. The man did not have prostate cancer, said another urologist.Medscape Medical News (Source: Medscape Medical News Headlines)



Recent Reports About HIFU'Troubling'Recent Reports About HIFU'Troubling '

Wed, 07 Feb 2018 18:02:03 +0100

Despite new reports of HIFU for focalized therapy of prostate cancer, Dr Chodak remains unconvinced of its evidence.Medscape Urology (Source: Medscape Today Headlines)



Insightec closes $150m Series E

Wed, 31 Jan 2018 15:00:27 +0100

Insightec said today it closed a $150 million Series E private equity round of financing with plans to use funds to support marketing, commercialization and further development of its Exablate Neuro platform. The round was led by Koch Disruptive Technologies subsidiary Koch Industries, who invested a total of $100 million during the round, the Israel-based company said. The company’s flagship Exablate Neuro device, which won FDA approval last July for treating essential tremor, uses high-intensity, focused ultrasound to thermally ablate targeted tissue, guided by continuous magnetic resonance imaging; the procedure can be performed non-invasively through an intact skull. Proceeds from the round are slated to support marketing and commercialization for approved indications for its Exabl...



Insightec raises $150m in Series E

Fri, 15 Dec 2017 18:23:10 +0100

Insightec said yesterday it raised $150 million in a Series E round of financing led by Koch Industries’ Koch Disruptive Technologies to support its MRI-guided focused ultrasound technologies. The round was led by Koch Disruptive Technologies and joined by existing investors Elbit Imaging, York Capital, Focus Holdings, GE Healthcare (NYSE:GE), GEOC and Meditech Advisors, the Israel-based company said. “This investment aligns well with the founding principles of both Koch Disruptive Technologies and Koch Industries. With a track record of driving innovation and improving patient outcomes, Insightec has itself invested and expanded its capabilities to advance surgical medicine to improve the health and quality of life of millions of patients,” KDT prez Chase Koch said in ...



Insightec wins FDA nod for Exablate Neuro glioblastoma trial

Tue, 28 Nov 2017 21:15:16 +0100

Insightec said today it won FDA approval to launch a safety and feasibility trial of its Exablate Neuro, testing its ability to disrupt the blood brain barrier in patients with glioblastoma. The Exablate Neuro device, which won FDA approval last July for treating essential tremor, uses high-intensity, focused ultrasound to thermally ablate targeted tissue, guided by continuous magnetic resonance imaging; the procedure can be performed non-invasively through an intact skull. In the trial, a research team will inject commonly used a sonographic microbubble solution into the bloodstream of a patient with a malignant brain tumor, after which ultrasound will be used to oscillate the microbubbles to cause temporary disruption of the blood brain barrier. “Clinical research is critical for...

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WakeMed partnership expands new cancer treatment availability

Thu, 02 Nov 2017 18:34:03 +0100

A new partnership between WakeMed Health& Hospitals and Charlotte-based HIFU Prostate Services has expanded the availability of a cancer treatment. (Source: bizjournals.com Health Care:Biotechnology headlines)



SonaCare highlights Medicare payment hike for HIFU

Thu, 21 Sep 2017 16:38:53 +0100

High-intensity focused ultrasound (HIFU) developer SonaCare Medical said that...Read more on AuntMinnie.comRelated Reading: SonaCare points to new Medicare HIFU reimbursement code SonaCare debuts international HIFU prostate registry New HIFU center launches in Ohio SonaCare, Invivo team up for HIFU ablation tracking SonaCare lands FDA nod for HIFU system (Source: AuntMinnie.com Headlines)



Edap submits new FDA 510(k) for Focal One HIFU

Tue, 12 Sep 2017 17:24:43 +0100

Edap (NSDQ:EDAP) said today it submitted a new FDA 510(k) application for its next-gen high-intensity focused ultrasound Focal One device designed to treat prostate cancer after withdrawing its previous application in July. The new application alllowed the France-based company to include a new set of clinical data, which it had decided to include following “advanced discussions” with the FDA earlier this year. “The new 510k review may be more efficient as the updates only pertain to the clinical section which includes new studies from active and academic Focal One centers in Europe. Our regulatory and clinical teams have been working diligently to gather the new set of data. As the new 510(k) application differs mainly within the clinical section, we will work closely w...



SonaCare Medical Delivers Compatability With bkFusion

Wed, 30 Aug 2017 12:46:20 +0100

CHARLOTTE, N.C., Aug. 30, 2017 -- (Healthcare Sales & Marketing Network) -- SonaCare Medical, the leading developer and manufacturer of high intensity focused ultrasound (HIFU) technologies, announces today the successful collaboration with BK Ultrasound,... Devices SonaCare Medical, Sonablate, BK Ultrasound, HIFU (Source: HSMN NewsFeed)



Theraclion highlights HIFU research for Graves' disease

Wed, 30 Aug 2017 07:00:00 +0100

Therapeutic ultrasound technology developer Theraclion is pointing to a clinical...Read more on AuntMinnie.comRelated Reading: Theraclion's Echopulse wins IDE from FDA (Source: AuntMinnie.com Headlines)

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MR-HIFU is kid-safe for osteoid osteoma

Fri, 25 Aug 2017 21:27:52 +0100

MR-guided high-intensity focused ultrasound (MR-HIFU) appears to provide safe,...Read more on AuntMinnie.comRelated Reading: New trial will assess MR-HIFU, chemo drug combo DC docs use MR-HIFU to treat bone tumor FDA approves Philips, Celsion HIFU study (Source: AuntMinnie.com Headlines)



Profound Medical raises $8m for urology, women ’ s health devices

Fri, 25 Aug 2017 14:42:43 +0100

Profound Medical (TSX:PRN) said today that it inked an $8 million “bought” deal” financing with a pair of underwriters that it plans to use for its Tulsa-Pro and Sonalleve ablation devices. The funding, by Echelon Wealth Partners and  CIBC Capital Markets, involved 10 million units at 80¢ (C$1 ) apiece, consisting of a stock share and a half of a 36-month warrant priced at $1.12 (C$1.40), the Toronto-based company said. The deal also includes a 30-day over-allotment option for another 1.5 million shares, which if exercised would push the gross proceeds to $9.2 million (C$11.5 million). Profound said it plans to use the proceeds to cover clinical work for the Tulsa-Pro MR-guided prostate ablation treatment and the Sonalleve MR-HIFU device for treating uterine fibroids a...



Study shows incisionless surgery with MR-HIFU effective in destroying painful bone tumors

Thu, 24 Aug 2017 04:00:00 +0100

(Children's National Health System) Doctors from the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children's National Health System have completed a clinical trial that demonstrates how osteoid osteoma, a benign but painful bone tumor that commonly occurs in children and young adults, can be safely and successfully treated using an incisionless surgery method called magnetic resonance-guided high-intensity focused ultrasound. (Source: EurekAlert! - Medicine and Health)



Hybrid modalities disappoint in bone metastases accuracy

Mon, 21 Aug 2017 07:00:00 +0100

Despite the apparent technological advantages of SPECT/CT, PET/CT, and PET/MRI,...Read more on AuntMinnie.comRelated Reading: ASTRO updates guidelines on painful bone metastases PET/CT CAD finds common spinal metastases PET/MRI detects distant metastasis of breast cancer DC docs use MR-HIFU to treat bone tumor FDG-PET/MRI shows advantages with malignant bone lesions (Source: AuntMinnie.com Headlines)



Profound Medical closes $6m Philips Sonalleve MR-HIFU biz buy

Tue, 01 Aug 2017 18:28:41 +0100

Profound Medical (TSX:PRN) said today it closed its $6 million acquisition of Royal Philips (NYSE:PHG) Sonalleve MR-HIFU business Philips Sonalleve MR-HIFU platform features real-time MR imaging and thermometry alongside high intensity focused ultrasound for incision-free ablation of tissue, Toronto-based Profound Medical said. “This transaction with Philips is truly transformative for Profound, and represents an opportunity for us to immediately transition from a development-stage to a growth-stage company,. From a commercial perspective, our strengthened MR-Ultrasound ablation technology platform not only benefits Profound by significantly increasing the total opportunity size and creating synergies, but also benefits hospital customers by providing them with the ability to bette...

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EDAP submits FDA 510(k) for Ablatherm Fusion HIFU device

Tue, 01 Aug 2017 16:56:10 +0100

Edap (NSDQ:EDAP) said this week it submitted an FDA 510(k) application for its next-gen Ablaterm Fusion device. The Lyon, France-based company’s next-generation Ablatherm Fusion is a robotic high-intensity focused ultrasound device designed to allow urologists to import pre-treatment diagnostic info, including MRI images and 3D biopsy maps, and merge them with live ultrasound images during prostate tissue ablation procedures. The device features the company’s proprietary fusion algorithm, and is designed to be used with its existing range of HIFU devices. “As recently mentioned, the next generation of Ablatherm devices merge MRI, 3D biopsy maps, and ultrasound images by integrating EDAP’s proprietary software and fusion algorithm. This  innovative, state of the art op...



No License: HIFU Prostate Cancer Doc Arrested No License: HIFU Prostate Cancer Doc Arrested

Tue, 25 Jul 2017 15:09:16 +0100

Dr Ronald Wheeler has repeatedly been in the news for his prostate cancer diagnosis and treatment beliefs and methods.Medscape Medical News (Source: Medscape Medical News Headlines)



Philips posts imaging sales gain in Q2

Mon, 24 Jul 2017 23:17:10 +0100

Royal Philips said that its Diagnosis and Treatment segment, which includes...Read more on AuntMinnie.comRelated Reading: Philips to acquire imaging software firm TomTec Philips partners on CT dose management initiative Philips, Varian, IBA partner on Singapore cancer center Philips to move MR-HIFU business to Profound Philips buys catheter developer CardioProlific (Source: AuntMinnie.com Headlines)



Philips to acquire TomTec ’ s imaging software

Wed, 19 Jul 2017 17:19:15 +0100

Royal Philips (NYSE:PHG) said yesterday that it agreed to acquire TomTec Imaging Systems and its intelligent image analysis software for an undisclosed amount. Munich-based TomTec makes multi-modality and vendor-neutral diagnostic and analysis applications for cardiology, radiology and OB/GYN, the Dutch healthcare conglomerate said. Founded in 1990, TomTec employs more than 100 workers in the U.S., Europe and Asia. Philips said it plans to continue to offer the acquisition’s vendor-neutral product line, integrating its medical software applications into third-party systems. The deal was expected to close yesterday, Philips said. “We are committed to providing ultrasound solutions that combine superb image quality with advanced analytics to drive efficiency and reproducibility...



Philips to acquire imaging software firm TomTec

Tue, 18 Jul 2017 16:31:03 +0100

Royal Philips has signed an agreement to acquire German imaging software developer...Read more on AuntMinnie.comRelated Reading: Philips partners on CT dose management initiative Philips, Varian, IBA partner on Singapore cancer center Philips to move MR-HIFU business to Profound TomTec nets FDA OK for new software TomTec launches cardiac visualization software at ACC TomTec launches online teaching tool (Source: AuntMinnie.com Headlines)

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EDAP pulls FDA bid for Focal One, plans to resubmit with new data

Tue, 18 Jul 2017 16:22:58 +0100

Edap (NSDQ:EDAP) said today it withdrew the FDA 510(k) application for its next-gen high-intensity focused ultrasound Focal One device designed to treat prostate cancer. The French company said that following “advanced discussions” with the federal watchdog, it plans to submit a new 510(k) application which includes new clinical data. “As mentioned during our last quarterly call, a shift in biopsy protocol has created difficulties in comparing biopsy data under the current 510k application. We actively worked with some of our key users in Europe to gather new and additional clinical data on Focal One in order to provide them to the agency for review. It is not possible to include this new clinical data in our current file under review, and thus need to withdraw our curr...



Philips partners on CT dose management initiative

Mon, 17 Jul 2017 18:24:24 +0100

Royal Philips and West Physics are collaborating to create a CT radiation dose...Read more on AuntMinnie.comRelated Reading: Philips, Varian, IBA partner on Singapore cancer center Philips to move MR-HIFU business to Profound Philips buys catheter developer CardioProlific Philips to buy Spectranetics in $2.2B deal Philips lands FDA nod for new IntelliSpace applications (Source: AuntMinnie.com Headlines)



Philips, Varian, IBA partner on Singapore cancer center

Wed, 12 Jul 2017 16:46:17 +0100

Royal Philips plans to collaborate with Varian Medical Systems and Ion Beam...Read more on AuntMinnie.comRelated Reading: Philips to move MR-HIFU business to Profound IBA inks Va. installation deal Philips buys catheter developer CardioProlific FDA clears Varian's Halcyon rad therapy system IBA to show updated synthesizer at SNMMI 2017 Varian to build radiation oncology centers in Vietnam (Source: AuntMinnie.com Headlines)



Philips to move MR-HIFU business to Profound

Thu, 06 Jul 2017 07:00:00 +0100

Royal Philips has made an agreement to transfer its MR-guided high-intensity...Read more on AuntMinnie.comRelated Reading: Philips buys catheter developer CardioProlific Philips to buy Spectranetics in $2.2B deal Philips lands FDA nod for new IntelliSpace applications Philips relaunches Pioneer Plus IVUS catheter Philips launches new business intelligence software (Source: AuntMinnie.com Headlines)



Philips picks up peripheral thrombectomy device maker CardioProlific

Wed, 05 Jul 2017 13:09:22 +0100

Royal Philips (NYSE:PHG) last week said it paid an unspecified amount to acquire stealthy CardioProlific and the peripheral thrombectomy catheters it’s developing. Philips said the deal for Hayward, Calif.-based CardioProlific is complementary to its $2.16 billion acquisition of Spectranetics (NSDQ:SPNC) and its own line of image-guided therapies. “The acquisition of CardioProlific will further strengthen our innovation pipeline of catheter-based therapy devices,” image-guided therapy business leader Bert van Meurs said in prepared remarks. “We are convinced that the development of CardioProlific’s differentiated thrombectomy technologies, combined with our suite of image-guided therapy solutions, will help our customers drive the procedure innovation for th...

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Profound Medical to pay $6m for Philips ’ Sonalleve MR-HIFU biz

Fri, 30 Jun 2017 14:36:29 +0100

Profound Medical (TSX:PRN) said today that it agreed to put up about $6 million worth of its own shares to acquire the Sonalleve MR-HIFU business from Royal Philips (NYSE:PHG). Toronto-based Profound said the deal calls for it to put up 7.4 million shares at 84.9¢ (C$1.10) apiece, representing a 22% premium over its closing price yesterday. The total deal value is $6.3 million (C$8.1 million) The agreement also has earn-outs pegged to future revenues of 5% to 7% of Sonnalleve sales through 2020, the company said. Philips, which already sells Profound’s Tulsa-Pro prostate ablation system, also pledged to distribute the Sonalleve device which is mostly used to ablate uterine fibroids. “This agreement with Philips is in keeping with our commitment to invest in the powerful comb...



Theraclion partner UVA wins FDA nod for combined HIFU, immunotherapy breast cancer trial

Tue, 27 Jun 2017 15:24:16 +0100

Theraclion said yesterday its academic development partner, the University of Virginia, won  an FDA nod to launch a study of the combined use of echotherapy high intensity focused ultrasound and immunotherapy drug pembrolizumab for treating patients with breast cancer. The study will examine the combined treatment’s effect on fighting breast cancer tumor cells, the French company said. Theraclion is hopeful that HIFU treatment may locally potentiate immune responses induced by the immunotherapy drugs. Read the whole story at our sister site, Drug Delivery Business   The post Theraclion partner UVA wins FDA nod for combined HIFU, immunotherapy breast cancer trial appeared first on MassDevice. (Source: Mass Device)



Echotherapy: A Future Option for Benign Thyroid Nodule Symptoms? Echotherapy: A Future Option for Benign Thyroid Nodule Symptoms?

Wed, 07 Jun 2017 11:56:31 +0100

High-intensity focused ultrasound ablation, or echotherapy, of symptomatic but benign solid thyroid nodules is an emerging technology, available in a few clinics in Europe.Medscape Medical News (Source: Medscape Medical News Headlines)



Theraclion touts Echopulse data from thyroid nodules studies

Wed, 24 May 2017 18:54:32 +0100

Theraclion (EPA:ALTHE) touted data today from 3 studies evaluating the use of Echopulse as a non-invasive treatment for benign thyroid nodules. One of the studies was the 1st direct comparison of echotherapy to surgery. The study, which was published in the International Journal of Hyperthermia, compared 43 patients who were treated with Theraclion’s Echopulse, an ultrasound-guided high-intensity focused ultrasound system, to 103 patients who underwent hemithyroidectomy. Patients who were treated with the French company’s system experienced significantly lower incidence of subclinical hypothyroidism, better symptoms improvement scores, shorter length of hospital stay and better voice quality after 1 month. The 2nd study, published in Radiology, compared patients with sympt...



SonaCare points to new Medicare HIFU reimbursement code

Tue, 23 May 2017 17:10:34 +0100

High-intensity focused ultrasound (HIFU) developer SonaCare Medical said the...Read more on AuntMinnie.comRelated Reading: SonaCare debuts international HIFU prostate registry New HIFU center launches in Ohio SonaCare, Invivo team up for HIFU ablation tracking SonaCare lands FDA nod for HIFU system SonaCare teams up with Invivo (Source: AuntMinnie.com Headlines)

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EDAP touts CMS reimbursement win for HIFU prostate ablation

Mon, 22 May 2017 19:42:57 +0100

Edap (NSDQ:EDAP) today touted that the Centers for Medicare & Medicaid Services established reimbursement billing codes for high intensity focused ultrasound ablation procedures for prostate tissue. The French company said that the new CMS C-code covering HIFU ablation of prostate tissue procedures will take effect July 1. The code will cover procedures performed by its HIFU devices, including whole primary gland prostate ablation, partial prostate ablation or whole and partial salvage ablation. “We are elated by CMS’s decision. This is another key milestone in the acceptance and recognition of HIFU technology in the U.S. as reflected by CMS’s celerity in addressing the dossier, establishing a c-code and assigning a competitive coverage level. It will provide a choice be...



Insightec wins FDA nod for Exablate Neuro for use with 1.5T MRI

Tue, 09 May 2017 17:09:53 +0100

Insightec said today it won FDA approval for its Exablate Neuro model 4000 system, now cleared for use with 1.5 Tesla magnetic resonance imaging  for treating essential tumor in patients non-responsive to medication. The Exablate Neuro device uses high-intensity, focused ultrasound to thermally ablate targeted tissue, guided by continuous magnetic resonance imaging; the procedure can be performed non-invasively through an intact skull. “Being able to bring MR-guided focused ultrasound to hospitals that have 1.5T MRIs will enable more essential tremor patients to have access to this non-invasive treatment option using Insightec’s ground-breaking technology,” CEO & board chair Dr. Maurice Ferré said in a press release. The company won a nod from the FDA for the Exab...



Insightec touts 1st patient treated in Exablate Neuro FDA feasibility trial

Thu, 20 Apr 2017 21:14:25 +0100

Insightec today announced that the 1st patient has been treated in a feasibility trial exploring the use of its Exablate Neuro system for treating benign centrally-located intracranial tumors in pediatric and young adults. The Exablate Neuro device uses high-intensity, focused ultrasound to thermally ablate targeted tissue, guided by continuous magnetic resonance imaging; the procedure can be performed non-invasively through an intact skull. A team at the Nicklaus Children’s Hospital performed the 1st procedure on a 21-year old patient suffering from seizures associated with a benign hypothalamic hamartoma brain tumor. “This breakthrough first procedure sets the stage for us to provide incisionless surgery for young patients with benign centrally-located brain tumors. Our tea...



SonaCare debuts international HIFU prostate registry

Tue, 11 Apr 2017 16:55:01 +0100

High-intensity focused ultrasound (HIFU) technology developer SonaCare Medical...Read more on AuntMinnie.comRelated Reading: New HIFU center launches in Ohio SonaCare, Invivo team up for HIFU ablation tracking HIFU Prostate opens up Ohio treatment center HIFU Prostate Services signs Texas client SonaCare lands FDA nod for HIFU system (Source: AuntMinnie.com Headlines)



International Sonablate HIFU Prostate Registry Officially Launched

Tue, 11 Apr 2017 12:48:29 +0100

The HEAT Registry, with more than 1,500 patients, begins enrollment of U.S. patients CHARLOTTE, N.C., April 11, 2017 -- (Healthcare Sales & Marketing Network) -- SonaCare Medical, the leading developer and manufacturer of high intensity focused ultraso... Devices, Urology SonaCare Medical, Sonablate, HIFU, HEAT Registry (Source: HSMN NewsFeed)

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Theraclion touts 2-year Echopulse data from breast fibroadenoma study

Fri, 07 Apr 2017 22:32:37 +0100

Theraclion (EPA:ALTHE) this week released 2-year results from a trial of its Echopulse non-invasive ultrasound system for treating breast fibroadenoma. Study results were published in the March 2017 issue of the Journal of Therapeutic Ultrasound, the French company said. The 20 patient study examined the use of the Echopulse system, an ultrasound-guided high-intensity focused ultrasound device, in reducing the volume of 26 breast fibroadenomas, or benign tumors. Data indicated that mean BFA volume was reduced by 77.32% after a single procedure and 90.47% after 2 procedures at 2 years. No cases of re-growth of treated lesions were observed at 2 years, and treatment was well tolerated regardless of the number of sessions performed, researchers said. No serious side effects were observed. ...



Scientists have discovered a way to destroy cancer tumors using nothing but sound waves

Wed, 29 Mar 2017 22:13:37 +0100

(Natural News) A recent breakthrough in high-intensity focused ultrasound therapy (HIFU) technology has proven its use as an effective cancer treatment. A multi-institutional research team from China developed a semi-enclosed, spherical cavity transducer that can produce a focused, standing-wave field with a subwavelength-scale focal region and extremely high ultrasound intensity. The spherical cavity transducer appeared to generate tighter... (Source: NaturalNews.com)



New method heats up ultrasonic approach to treating tumors

Tue, 28 Mar 2017 17:55:05 +0100

High-intensity focused ultrasound (HIFU) is a breakthrough therapeutic technique used to treat tumors. The principle of this noninvasive, targeted treatment is much like that of focusing sunlight through a lens, using an ultrasonic transducer like a convex lens to concentrate ultrasound into a small focal region. Researchers have now designed a transducer for potential application in HIFU that can generate a steady, standing-wave field with a subwavelength-scale focal region and extremely high ultrasound intensity. (Source: ScienceDaily Headlines)



Hitting cancer with high-intensity ultrasound, immunotherapy

Thu, 23 Mar 2017 22:31:32 +0100

In a new study, researchers have shown that combining high-intensity focused ultrasound with two immunotherapies (a PD-1 checkpoint inhibitor and TLR9 agonist) can produce excellent response rates in mouse models of epithelial cancer. They also found that, for the combination to be effective, immunotherapies must come first. (Source: ScienceDaily Headlines)

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MRI-guided high-intensity focused ultrasound therapy for uterine fibroids has potential

Wed, 22 Mar 2017 04:00:00 +0100

(Institute for Quality and Efficiency in Health Care) IQWiG has attributed a potential for a benefit to a new treatment method according to § 137e SGB V. A testing study has been initiated. Numerous other assessments had no consequences. (Source: EurekAlert! - Medicine and Health)



High-Intensity Focused Ultrasound for Focal Therapy High-Intensity Focused Ultrasound for Focal Therapy

Mon, 27 Feb 2017 14:05:36 +0100

Focal HIFU shows promise for the treatment of prostate cancer, but important questions remain.Current Opinion in Urology (Source: Medscape Today Headlines)



First patients treated in pivotal trial for Theraclion ’ s Echopulse device

Thu, 09 Feb 2017 20:04:39 +0100

Theraclion (EPA:ALTHE) said today that the 1st patients were treated in the U.S. pivotal clinical trial evaluating the safety and efficacy of the company’s Echopulse echotherapy device as a non-invasive treatment for breast fibroadenomas. The clinical trial is slated to enroll 100 patients, the France-based company said, at 4 sites across the U.S. and 1 site in Germany. Patients will receive a single high-intensity treatment with Echopulse. The study’s primary endpoint is a reduction of fibroadenoma volume, pain and anxiety. “High intensity focused ultrasound (HIFU) technology is exciting because it has the potential to provide patients with an alternative to surgery, avoiding a scar, with minimal interruption in their normal daily activity,” principal investigator...



HIFU-Hemiablation for Treatment of Prostate Cancer? HIFU-Hemiablation for Treatment of Prostate Cancer?

Tue, 31 Jan 2017 19:59:19 +0100

Dr Gerald Chodak questions the value of the IDEAL study to evaluate HIFU-hemiablation as the primary treatment for prostate cancer.Medscape Urology (Source: Medscape Hematology-Oncology Headlines)



FDA clears next-gen Sonablate prostate device from SonaCare

Wed, 11 Jan 2017 15:14:33 +0100

SonaCare Medical said today that it won 510(k) approval from the FDA for the latest version of its high intensity focused ultrasound prostate tissue ablation device. The Sonablate device was the 1st of its kind to receive regulatory approval for the focused ablation of prostate tissue, according to SonaCare. The next-gen version features a tool to quantify changes in tissue composition following treatment. It also boasts an altered delivery sequence in combination with an automated planning system that can reduce the overall procedure time by 40%, the Charlotte, N.C.-based company reported. “We worked diligently with the FDA to provide clinical data consistent with the requirements established in the de novo authorization SonaCare Medical received for Sonablate in 2015,” CEO Dr...

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SonaCare Medical Granted FDA Regulatory Clearance for Updated HIFU Prostate Tissue Ablation Device

Wed, 11 Jan 2017 14:01:40 +0100

CHARLOTTE, N.C., Jan. 11, 2017 -- (Healthcare Sales & Marketing Network) -- SonaCare Medical, leading developer and manufacturer of high intensity focused ultrasound (HIFU) technologies, reports receipt of 510(k) regulatory clearance to market its latest ... Devices, Urology, FDA SonaCare Medical, Sonablate, HIFU (Source: HSMN NewsFeed)



Celsion ’ s ThermoDox activated by ultrasound in pediatric cancer study

Fri, 06 Jan 2017 18:50:50 +0100

Celsion (NSDQ:CLSN) and Children’s National Health System are teaming up to tackle refractory solid tumors in pediatric patients using a heat-activated chemotherapy drug and noninvasive ultrasound. The Phase I clinical trial, which launched last November, is the 1st of its kind in the U.S. Lawrenceville, N.J.-based Celsion’s ThermoDox is a heat-activated liposomal doxorubicin. In combination with MRI, high-intensity focused ultrasound is used to direct sound wave energy and heat the tumor. When the liposomal chemotherapy drug comes into contact with the heated tumor, the liposome changes structure and releases doxorubicin into the tumor. Get the full story at our sister site, Drug Delivery Business News. The post Celsion’s ThermoDox activated by ultrasound in pediatri...



Parkinson's UK comments on the first non-invasive ultrasound that can help patients with tremors

Mon, 12 Dec 2016 14:00:00 +0100

Claire Bale, Head of Research Communications and Engagement at Parkinson's UK, comments on Imperial College Healthcare NHS trust using high-intensity, focused ultrasound waves for the first time in... (Source: Parkinson's Disease News From Medical News Today)



New trial will assess MR-HIFU, chemo drug combo

Wed, 16 Nov 2016 17:29:45 +0100

The Children's National Health System in Washington, DC, and oncology drug...Read more on AuntMinnie.comRelated Reading: FDA OKs InSightec's MRgFUS tremor treatment device New HIFU center launches in Ohio SonaCare, Invivo team up for HIFU ablation tracking Prostate HIFU available for 1st time in U.S. SonaCare lands FDA nod for HIFU system (Source: AuntMinnie.com Headlines)



Pricey New Treatment Roils Issues of How to Treat Prostate Cancer Pricey New Treatment Roils Issues of How to Treat Prostate Cancer

Thu, 06 Oct 2016 20:21:51 +0100

High-intensity focused ultrasound, often not covered by insurance, leads to discussions about which patients benefit in the real world.Kaiser Health News (Source: Medscape Medical News Headlines)

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SonaCare Medical Paves the Way with the First HIFU Device Cleared by the FDA for Prostate Tissue Ablation - A Year in Review

Wed, 05 Oct 2016 13:37:24 +0100

CHARLOTTE, N.C., Oct. 5, 2016 -- (Healthcare Sales & Marketing Network) -- SonaCare Medical, leading developer and manufacturer of High Intensity Focused Ultrasound (HIFU) Technologies, reports over 40 acquisitions of Sonablate® technology since the d... Devices SonaCare Medical, Sonablate, HIFU (Source: HSMN NewsFeed)



Insightec inks ExAblate co-development deal with Siemens

Mon, 15 Aug 2016 22:11:52 +0100

Insightec said today it inked a collaborative strategic deal with Siemens Healthineers (NYSE:SI) to develop compatibility between Insightec’s Exablate Neuro system and Siemens Magnetom Aera and Skyra 1.5 Tesla and 3T clinical MRI systems. The companies said the agreement will expand Siemens diagnostic imaging portfolio and will allow existing and future Siemens MRI customers access to the Exablate Neuro system. “Our agreement with Siemens Healthineers will allow us to significantly expand Exablate Neuro’s market presence. Siemens has embraced our technology and together we will bring our therapy to significantly more patients and providers. Insightec is committed to continue investing in research and development of MRgFUS technology. The strategic collaboration with Sie...



MassDevice.com +5 | The top 5 medtech stories for July 11, 2016

Mon, 11 Jul 2016 19:00:52 +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. FDA approves Insightec’s Exablate Neuro focused ultrasound device The FDA said today that it approved the Exablate Neuro device made by Insightec for treating essential tremor in patients who don’t respond to drug therapy. The Exablate Neuro device uses high-intensity, focused ultrasound to thermally ablate targeted tissue, guided by continuous magnetic resonance imaging; the procedure can ...



FDA approves Insightec’s Exablate Neuro focused ultrasound device

Mon, 11 Jul 2016 17:15:07 +0100

The FDA said today that it approved the Exablate Neuro device made by Insightec for treating essential tremor in patients who don’t respond to drug therapy. The Exablate Neuro device uses high-intensity, focused ultrasound to thermally ablate targeted tissue, guided by continuous magnetic resonance imaging; the procedure can be performed non-invasively through an intact skull. Essential tremor can be treated with beta blockers or anti-convulsant drugs, but some patients don’t respond to drug treatment, the federal safety watchdog said. A surgical treatment called thalamotomy or deep-brain stimulation can also be used to destroy portions of the thalamus, which controls some involuntary movements. Insightec applied for pre-,arket approval for the Exablate Neuro treatment in Octo...



First Prostate Cancer Patients Treated with HIFU Technology

Wed, 25 May 2016 14:51:44 +0100

Cordell Nwokeji, MD and Don Berardinucci, MD perform first Sonablate HIFU treatments in Houston, Texas at Houston Metro Urology in partnership with HIFU Prostate Services (Source: Disabled World)

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'Caution Optimism' for HIFU in Prostate Cancer

Fri, 13 May 2016 17:27:16 +0100

(MedPage Today) -- Radical treatment avoided for 2 years in 90% of patients (Source: MedPage Today Primary Care)



'Cautious Optimism' for HIFU in Prostate Cancer

Fri, 13 May 2016 17:27:16 +0100

(MedPage Today) -- Radical treatment avoided for 2 years in 90% of patients (Source: MedPage Today Urology)



Prostate Cancer: French HIFU Study Adds to DebateProstate Cancer: French HIFU Study Adds to Debate

Wed, 11 May 2016 16:07:57 +0100

A French study used HIFU to perform hemiablation of the prostate in men with low- and intermediate-risk cancer, adding to the debate on how and when the approach should be used. Medscape Medical News (Source: Medscape Medical News Headlines)



New FDA-Approved Prostate 'Tool': Will You HIFU?New FDA-Approved Prostate 'Tool': Will You HIFU?

Sun, 08 May 2016 14:12:34 +0100

High-intensity focused ultrasound (HIFU) is approved for prostate ablation but not for the treatment of prostate cancer. Why? What now? Medscape Medical News (Source: Medscape Hematology-Oncology Headlines)



SonaCare, Invivo team up for HIFU ablation tracking

Fri, 06 May 2016 18:15:25 +0100

High-intensity focused ultrasound (HIFU) developer SonaCare Medical said it...Read more on AuntMinnie.comRelated Reading: SonaCare lands FDA nod for HIFU system SonaCare teams up with Invivo CorTechs renews distribution deal with Invivo SonaCare names CFO iCAD and Invivo collaborate (Source: AuntMinnie.com Headlines)

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SonaCare inks marketing deal with Philips’ Invivo biz for its UroNav software

Thu, 05 May 2016 22:51:46 +0100

SonaCare Medical said today it inked a marketing alliance deal with Royal Philips (NYSE:PHG) business Invivo to license its UroNav fusion software with its Sonablate planning system. The new deal will allow clinicians to use the UroNav device to annotate and biopsy targeted prostate tissue and localize the tissue appropriate for ablation directly with its Sonablate software, Charlotte, N.C.-based SonaCare said. “This is a major strategic partnership for SonaCare. Working together, Invivo and SonaCare are putting in place a broad product portfolio for performing advanced diagnostics, targeted ablation, and systematic patient follow up, as well as a means for delivering that platform to the market. These are very exciting times for both of our organizations and for the physicians and p...



Edap looks to raise $11m in direct placement round

Thu, 07 Apr 2016 16:20:36 +0100

Edap (NSDQ:EDAP) said today it inked an agreement with institutional investors for the placement of 3.3 million shares at $3.50 a piece, bringing in an estimated $11.5 million for the company. Investors in the round will receive warrants to purchase up to 3.3 million shares at an exercise price of $4.50 per share, exchangeable beginning 6 months from the date issued and for a period of 2 years after, Edap said. The French company said it expects the offering to close on or around April 14. H.C. Wainwright & Co. acted as the exclusive placement agent for the round, according to an SEC filing. Yesterday, EDAP said it submitted an application for FDA 510(k) clearance for its next-gen high-intensity focused ultrasound Focal One device designed to treat prostate cancer. The company said th...



Edap seeks FDA nod for Focal One HIFU

Wed, 06 Apr 2016 16:01:00 +0100

Edap (NSDQ:EDAP) said today it submitted an application for FDA 510(k) clearance for its next-gen high-intensity focused ultrasound Focal One device designed to treat prostate cancer. The company said the new submission comes following the FDA 510(k) clearance of its Ablatherm Robotic HIFU designed for the ablation of prostate tissue, which it won last November. “We are pleased to submit our Focal One HIFU device file to the FDA to further our goal of making EDAP’s full range of HIFU products available to both urologists and patients in the U.S. There is a clear, growing demand from the worldwide urology community for non-invasive options for the ablation of prostatic tissue, and we are well positioned to address this market with our complementary Ablatherm and Focal One devices. ...



HIFU for Prostate Cancer

Wed, 23 Mar 2016 03:43:10 +0100

MIAMI. (Ivanhoe Newswire) -- A treatment that can remove prostate cancer while still preserving a man’s quality of life. It’s now available in the United States for the first time ever. It’s called high-intensity focused ultrasound, or HIFU. (Source: Medical Headlines From Ivanhoe.com)



Unilateral HIFU: More Cons Than Pros(tate)?Unilateral HIFU: More Cons Than Pros(tate)?

Fri, 11 Mar 2016 15:44:46 +0100

A small study of high-intensity focused ultrasound in localized prostate cancer fails to make the case for this treatment option, says Dr Gerald Chodak. Medscape Urology (Source: Medscape Hematology-Oncology Headlines)

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HIFU in Prostate Cancer: Are Patients 'Guinea Pigs'?HIFU in Prostate Cancer: Are Patients 'Guinea Pigs'?

Thu, 03 Mar 2016 15:32:13 +0100

The FDA rejected high-intensity ultrasound (HIFU) for treating prostate cancer and then approved a device as safe for 'prostate ablation.' Is that a mixed message? Medscape Urology (Source: Medscape Radiology Headlines)



ERP Therapy, Where Are You?

Mon, 15 Feb 2016 18:45:04 +0100

I recently received an email from a woman in her thirties who has had obsessive-compulsive disorder since she was a child. She came across one of my articles and was interested in learning more about exposure and response prevention (ERP) therapy, as she had never heard of it. She had been to all kinds of health care providers over the years, yet she had never heard of ERP. Unfortunately, emails such as hers are not uncommon, but they sure are frustrating. She’s had OCD for twenty plus years and never heard of ERP? This realization jolts me out of my little corner of the world (or blogosphere) where everyone knows about ERP therapy because we talk about it over and over again. Is progress actually being made? Are we really getting the word out? Sometimes I just don’t think so. It’s b...



Experimental ultrasound treatment zaps cancer pain

Fri, 29 Jan 2016 23:25:41 +0100

High-intensity focused ultrasound blasts cells that trigger pain; "When the pain is less, or the pain is gone, you're back to being normal" (Source: Health News: CBSNews.com)



12 Amazing Things We Learned About The Human Body In 2015

Tue, 22 Dec 2015 12:15:55 +0100

The human body is a source of mystery. But every year, scientists get just a little better at understanding its secrets.  Of course, 2015 has been no different. In the past year, researchers have created better access to proven therapies, developed futuristic new technologies that may change the way we approach disease and even enacted more complete disease screening processes to keep us healthy.  Read on to learn more. Here’s to more scientific discoveries in 2016!   @media (max-width: 969px) { #desktop { display: none; } } @media (min-width: 970px) { #mobile { display: none; } } #g-body-desktop-graphic .graphic-hed { font-family: 'Source Sans Pro', Helvetica, sans-serif; font-size: 26px; line-height: 32px; font-weight: bold; padding: 5px 10px; } .graphic-h...



Celsion wins Chinese approval for ThermoDox study

Wed, 16 Dec 2015 17:45:34 +0100

Oncology drug developer Celsion has won clinical trial approval from the China...Read more on AuntMinnie.comRelated Reading: FDA approves Philips, Celsion HIFU study Celsion, Philips resubmit MR-HIFU study Celsion, Focused Ultrasound support HIFU trials Philips, Celsion research program moves forward Philips inks research agreement with Celsion (Source: AuntMinnie.com Headlines)

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EDAP Receives Russian Regulatory Approval for Focal One(R) HIFU Device

Fri, 11 Dec 2015 13:27:12 +0100

LYON, France, Dec. 11, 2015 -- (Healthcare Sales & Marketing Network) -- EDAP TMS SA (EDAP), the global leader in therapeutic ultrasound, today announced that Russia's Federal Service for Surveillance in Healthcare (Roszdravnadzor) has approved Focal One f... Devices, Oncology, Urology, RegulatoryEDAP TMS, Ablatherm, HIFU, prostate cancer (Source: HSMN NewsFeed)



Edap slips shareholders lawsuit

Thu, 12 Nov 2015 14:50:46 +0100

Edap (NSDQ:EDAP) said yesterday that the appeal deadline lapsed for a shareholders lawsuit filed after an FDA advisory panel recommended against approval for its its Ablatherm device for treating prostate cancer. EDAP shares plunged last year after the FDA’s Gastroenterology & Urology Devices panel voted that the device did not appear to be effective or safe. Ablatherm, which won 510(k) clearance from the federal safety watchdog earlier this week, uses highhigh-intensity focused ultrasound to ablate prostate tissue. Shareholders sued in August 2014, accusing Edap of misleading investors by exaggerating Ablatherm’s safety and efficacy and understating adverse events. In September, a New York federal judge dismissed the case, ruling that the defendants failed to prove any ...



Prostate HIFU available for 1st time in U.S.

Mon, 09 Nov 2015 17:46:58 +0100

HIFU Prostate Services, a provider of minimally invasive prostate cancer treatment...Read more on AuntMinnie.comRelated Reading: SonaCare lands FDA nod for HIFU system (Source: AuntMinnie.com Headlines)



FDA clears Edap’s Ablatherm prostate device

Mon, 09 Nov 2015 15:55:58 +0100

Edap (NSDQ:EDAP) said today that it won 510(k) clearance from the FDA for its Ablatherm, less than a month after a similar device from rival SonaCare won a nod from the federal safety watchdog. The Ablatherm device, like SonaCare’s Sonablate 450, is designed to ablate prostate tissue using high-intensity focused ultrasound. After a years-long dance with the FDA that saw it move from a pre-market approval application to a de novo bid, Edap applied for 510(k) clearance after the agency cleared the Sonablate 450 in October. Today the Lyon, France-based company said it expects to begin marketing the device in the U.S. immediately. “This is a tremendous achievement for the company and the result of many years of hard work from our team. This clearance represents a unique oppor...



Study Oversells HIFU Benefits, Especially in Low-Risk PCaStudy Oversells HIFU Benefits, Especially in Low-Risk PCa

Fri, 23 Oct 2015 15:14:40 +0100

Dr Gerald Chodak disputes the conclusions of a study comparing HIFU therapy with brachytherapy for patients with low or intermediate-risk prostate cancer. Medscape Urology (Source: Medscape Hematology-Oncology Headlines)

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FDA Approves First HIFU Device for Prostate Tissue AblationFDA Approves First HIFU Device for Prostate Tissue Ablation

Thu, 22 Oct 2015 22:18:29 +0100

After being nixed by their advisory committee last year, Sonablate 450, for use in prostate tissue ablation, has now received the green light from the FDA. FDA Approvals (Source: Medscape Medical News Headlines)



Insightec files PMA for Exablate Neuro

Thu, 22 Oct 2015 17:34:20 +0100

Insightec said today it submitted a premarket approval application to the FDA for its Exablate Neuro device seeking an indication to treat essential tremors. The Exablate Neuro uses high intensity focused ultrasound to thermally ablate targeted tissue and uses continuous magnetic resonance imaging to visualize anatomy to plan and monitor treatments and outcomes. The MR-guided focused ultrasound procedure can be performed non-invasively through an intact skull to relieve tremors in patients with essential tremors, the Israel-based company said. “This is another major achievement, our third clinical indication submitted for FDA approval and the first PMA for Neurosurgery. This represents our continued commitment to transform MRgFUS from an investigational technology to a standard of c...



FDA clears SonaCare HIFU prostate device, prompts Edap to yank de novo, go for 510k

Thu, 15 Oct 2015 22:39:02 +0100

SonaCare said it won FDA pre market approval for its high intensity focused ultrasound device designed to treat prostate cancer, causing competitor EDAP (NSDQ:EDAP) to yank the de novo application for its Ablatherm HIFU. SonaCare said its Sonablate 450 will be available in the U.S. this October. “The FDA regulatory authorization to market Sonablate in the U.S. is a milestone for non-invasive prostate care and a tremendous gain for men’s health. Men all over the world, in the more than 49 countries where it has already been authorized for use, have had access to this technology for prostate ablation. There are numerous peer reviewed articles attesting to its value in ablating the prostate while minimizing the occurrence of side effects. Our company is appreciative of the collaborat...



Focused ultrasound trial for depression gets underway

Tue, 29 Sep 2015 16:17:23 +0100

A team from Yonsei University College of Medicine in Seoul, South Korea, has...Read more on AuntMinnie.comRelated Reading: BCBS updates coverage for InSightec's MRgFUS DC docs use MR-HIFU to treat bone tumor Philips, Infraredx announce resale agreement Philips sells MR-HIFU unit in Jordan Celsion, Focused Ultrasound support HIFU trials (Source: AuntMinnie.com Headlines)



EDAP Provides Formal Response to FDA Addressing All Concerns Raised in July 2015 Ablatherm HIFU Letter

Tue, 25 Aug 2015 18:55:56 +0100

FDA De Novo 510(k) Review of Prostatic Tissue Ablation Device to Resume LYON, France, Aug. 25, 2015 -- (Healthcare Sales & Marketing Network) -- EDAP TMS SA (EDAP), the global leader in therapeutic ultrasound, today announced that on Friday August 21, 2... Devices, OncologyEDAP TMS, Ablatherm, HIFU, prostate cancer (Source: HSMN NewsFeed)

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Edap revives Ablatherm HIFU FDA approval bid

Tue, 25 Aug 2015 17:21:08 +0100

EDAP (NSDQ:EDAP) said today it hopes to renew the de novo application for its Ablatherm HIFU prostate cancer device after responding to a “deficiency list” letter it received in July. The letter detailed a 4-item list of issues and put the de novo process for Ablatherm, a computer-controlled high-intensity focused ultrasound device designed to ablate the entire prostate gland, on hold. The French firm said that the submission would allow the FDA to resume it’s review. “As anticipated, we were able to provide a complete formal response to the FDA’s requests in an expeditious manner, which has enabled them to resume active review of our direct De Novo petition. A major component of the response was completion of the reprocessing validation tests, which have ...



MassDevice.com +3 | The top 3 medtech stories for July 21, 2015

Tue, 21 Jul 2015 20:00:49 +0100

Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 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.   3. Researchers 3D print hearts to improve LAA operations Researchers in Australia are creating 3D replicas of patient’s hearts to plan out left atrial appendage closures using Boston Scientific‘s Watchman device, according to a new report from heartwire. Creating the 3D replica is useful in patients with complicated cardiovascular anatomy, where even advanced imaging methods can make it difficult to quantify the area of the appendage, researchers told heartwi...



FDA wants more from Edap on Ablatherm de novo bid

Tue, 21 Jul 2015 13:36:30 +0100

Edap (NSDQ:EDAP) today said the FDA wants more on its bid for de novo approval of its Ablatherm HIFU prostate cancer device, saying it needs to address 4 points raised by the federal safety watchdog before the process can resume. The news, following the French firm’s March announcement that it would abandon its pre-market approval application, sent EDAP shares up 7.5% to $3.75 apiece in pre-market trading today. The stock opened at $3.52 per share and was trading at $3.47 shortly after trading commenced. Last fall the FDA issued a “not approvable” letter to Edap on the Ablatherm device, a computer-controlled high-intensity focused ultrasound device designed to ablate the entire prostate gland, after an FDA advisory panel recommended against approval. But the FDA said Edap had un...



EDAP Names Francois Dietsch Chief Financial Officer

Tue, 14 Jul 2015 15:41:23 +0100

10-year EDAP Finance Manager to Succeed Eric Soyer LYON, France, July 14, 2015 -- (Healthcare Sales & Marketing Network) -- EDAP TMS SA (EDAP), the global leader in therapeutic ultrasound, today announced that Francois Dietsch, currently Group Financial... Devices, Oncology, PersonnelEDAP TMS, Ablatherm, high-intensity focused ultrasound, prostate cancer (Source: HSMN NewsFeed)



OncoBreak: HIFU in Prostate Ca, Something Fishy About Colon Ca

Wed, 11 Mar 2015 20:57:00 +0100

(MedPage Today) -- News, features, and commentary about cancer. (Source: MedPage Today Public Health)

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Edap shares jump on Health Canada nod for prostate device

Fri, 09 Jan 2015 16:29:35 +0100

Edap shares gain today after it reveals a nod from Health Canada for its Focal One HIFU device for treating prostate cancer. EDAP TMS SA, Health CanadaNews Well, Prostate, Regulatory/Compliance, Urologyread more (Source: Mass Device)



Groundbreaking Sound Based Technology to Ablate Renal Cancer

Wed, 29 Oct 2014 12:08:16 +0100

Dr. David Schulsinger spearheads pilot study for ablation of renal cell carcinoma with SonaCare Medical’s Sonatherm® Laparoscopic Soft Tissue HIFU Surgical Ablation Device.10/29/2014 (Source: Kidney Cancer Association)



FDA Advisory Panel Calls for More Data on HIFU TreatmentFDA Advisory Panel Calls for More Data on HIFU Treatment

Thu, 02 Oct 2014 19:03:00 +0100

An FDA advisory panel has voted against recommending approval of a high-intensity focused ultrasound treatment for recurrent prostate cancer. Medscape Medical News (Source: Medscape Medical News Headlines)



EDAP's Ablatherm(R)-HIFU Technology Highlighted at the World Congress of Endourology, Taiwan

Mon, 22 Sep 2014 12:35:56 +0100

(Source: Medical News (via PRIMEZONE))



EDAP Highlights HIFU Expertise at 7th International Symposium

Wed, 27 Aug 2014 13:56:37 +0100

Focal Therapy and Imaging in Prostate and Kidney Cancer08/27/2014 (Source: Kidney Cancer Association)

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HIFU for Prostate Cancer: Efficacy Data 'Lacking'HIFU for Prostate Cancer: Efficacy Data 'Lacking'

Mon, 11 Aug 2014 17:53:03 +0100

Dr. Gerald Chodak discusses an FDA panel's recent recommendation against approving high-intensity focused ultrasound (HIFU) for the treatment of prostate cancer. Medscape Urology (Source: Medscape Today Headlines)



Morning Break: HIFU Panned, Morcellators Pulled

Thu, 31 Jul 2014 13:45:00 +0100

(MedPage Today) -- Health news and commentary from around the Web, gathered by the MedPage Today staff. (Source: MedPage Today Cardiovascular)



FDA Panel Pans Approval of Ultrasound for Prostate CancerFDA Panel Pans Approval of Ultrasound for Prostate Cancer

Thu, 31 Jul 2014 10:00:53 +0100

An FDA advisory committee recommended against approval of high-intensity focused ultrasound for prostate cancer because of 'murkiness' of data. Medscape Medical News (Source: Medscape Medical News Headlines)



FDA Panel Pans HIFU for Prostate CancerFDA Panel Pans HIFU for Prostate Cancer

Thu, 31 Jul 2014 10:00:53 +0100

An FDA advisory committee recommended against approval of high-intensity focused ultrasound (HIFU) for prostate cancer because of 'murkiness' of data. Medscape Medical News (Source: Medscape Radiology Headlines)



HIFU for Prostate Cancer an 'Experimental Therapy'HIFU for Prostate Cancer an 'Experimental Therapy'

Wed, 11 Jun 2014 14:38:17 +0100

Focal therapy for prostate cancer -- dubbed 'male lumpectomy' because it targets a lesion and not the whole prostate -- should undergo randomized trials first, argues Dr. Gerald Chodak. Medscape Urology (Source: Medscape Today Headlines)

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EDAP outlines road to FDA approval for prostate cancer ultrasound therapy

Thu, 29 May 2014 11:59:00 +0100

French device maker EDAP TMS SA has a big month ahead as it pursues FDA approval for its Ablatherm-HIFU therapeutic ultrasound technology, preparing for regulatory inspections and launching a $9.3 million funding round. EDAP TMS SA, Food & Drug Administration (FDA)News Well, Regulatory/Clearance, Food & Drug Administration (FDA), Funding Roundup, Pre-Market Approval (PMA), Prostate, Ultrasoundread more (Source: Mass Device)



Press Release: EDAP's Ablatherm-HIFU FDA Panel Meeting Confirmed for July 30, 2014

Thu, 22 May 2014 16:20:02 +0100

EDAP TMS SANews Well, Press Release, Regulatory/Clearance, Food & Drug Administration (FDA), Pre-Market Approval (PMA), Prostate, Ultrasoundread more (Source: Mass Device)



Prostate cancer: EDAP lands FDA date for therapeutic ultrasound

Thu, 22 May 2014 16:19:24 +0100

EDAP TMS lands a July date with FDA advisors to review therapeutic ultrasound in treatment of localized prostate cancer. France-based EDAP TMS SA will get its day with the FDA next month, when the agency's expert advisors will review EDAP's Ablatherm-HIFU therapeutic ultrasound technology for treatment of prostate cancer. EDAP TMS SA, Food & Drug Administration (FDA)News Well, Regulatory/Clearance, Food & Drug Administration (FDA), Pre-Market Approval (PMA), Prostate, Ultrasoundread more (Source: Mass Device)



EDAP Announces Reimbursement of HIFU Treatment for Prostate Cancer by France's Ministry of Health

Mon, 21 Apr 2014 13:04:45 +0100

Strong Recognition of EDAP's HIFU Technology by France's Health Authorities LYON, France, April 21, 2014 -- (Healthcare Sales & Marketing Network) -- EDAP TMS SA (EDAP), the global leader in therapeutic ultrasound, announced today the reimbursement of p... Devices, Oncology, ReimbursementEDAP TMS, High Intensity Focused Ultrasound, prostate cancer (Source: HSMN NewsFeed)



EDAP Completes FDA Q&A Session for Its Ablatherm-HIFU Pre-Market Approval Application

Thu, 20 Mar 2014 14:10:58 +0100

(Source: Medical News (via PRIMEZONE))

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