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EDAP Provides Formal Response to FDA Addressing All Concerns Raised in July 2015 Ablatherm HIFU Letter
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)
Source: HSMN NewsFeed - August 25, 2015 Category: Pharmaceuticals Source Type: news

Edap revives Ablatherm HIFU FDA approval bid
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 h...
Source: Mass Device - August 25, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Clinical Trials Food & Drug Administration (FDA) Regulatory/Compliance Ultrasound EDAP TMS SA Source Type: news

MassDevice.com +3 | The top 3 medtech stories for July 21, 2015
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 p...
Source: Mass Device - July 21, 2015 Category: Medical Equipment Authors: MassDevice Tags: News Well plus Source Type: news

FDA wants more from Edap on Ablatherm de novo bid
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 hig...
Source: Mass Device - July 21, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Urology EDAP TMS SA Prostate Source Type: news

EDAP Names Francois Dietsch Chief Financial Officer
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)
Source: HSMN NewsFeed - July 14, 2015 Category: Pharmaceuticals Source Type: news

OncoBreak: HIFU in Prostate Ca, Something Fishy About Colon Ca
(MedPage Today) -- News, features, and commentary about cancer. (Source: MedPage Today Public Health)
Source: MedPage Today Public Health - March 11, 2015 Category: American Health Source Type: news

Edap shares jump on Health Canada nod for prostate device
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)
Source: Mass Device - January 9, 2015 Category: Medical Equipment Authors: Brad Perriello Source Type: news

Groundbreaking Sound Based Technology to Ablate Renal Cancer
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)
Source: Kidney Cancer Association - October 29, 2014 Category: Cancer & Oncology Source Type: news

FDA Advisory Panel Calls for More Data on HIFU TreatmentFDA Advisory Panel Calls for More Data on HIFU Treatment
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)
Source: Medscape Medical News Headlines - October 2, 2014 Category: Consumer Health News Tags: Hematology-Oncology News Source Type: news

EDAP's Ablatherm(R)-HIFU Technology Highlighted at the World Congress of Endourology, Taiwan
(Source: Medical News (via PRIMEZONE))
Source: Medical News (via PRIMEZONE) - September 22, 2014 Category: Pharmaceuticals Source Type: news

EDAP Highlights HIFU Expertise at 7th International Symposium
Focal Therapy and Imaging in Prostate and Kidney Cancer08/27/2014 (Source: Kidney Cancer Association)
Source: Kidney Cancer Association - August 27, 2014 Category: Cancer & Oncology Source Type: news

HIFU for Prostate Cancer: Efficacy Data 'Lacking'HIFU for Prostate Cancer: Efficacy Data 'Lacking'
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)
Source: Medscape Today Headlines - August 11, 2014 Category: Consumer Health News Tags: Hematology-Oncology Commentary Source Type: news

Morning Break: HIFU Panned, Morcellators Pulled
(MedPage Today) -- Health news and commentary from around the Web, gathered by the MedPage Today staff. (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - July 31, 2014 Category: Cardiology Source Type: news

FDA Panel Pans HIFU for Prostate CancerFDA Panel Pans HIFU for Prostate Cancer
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)
Source: Medscape Radiology Headlines - July 31, 2014 Category: Radiology Tags: Hematology-Oncology News Source Type: news

FDA Panel Pans Approval of Ultrasound for Prostate CancerFDA Panel Pans Approval of Ultrasound for Prostate Cancer
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)
Source: Medscape Medical News Headlines - July 31, 2014 Category: Consumer Health News Tags: Hematology-Oncology News Source Type: news