Category: EDAP TMS SASyndicate content

Medical device makers find new layer of regulation before earning CE Mark approval | Regulatory news for the week of August 4, 2014

August 5, 2014 by MassDevice

Here's a look at some of the top regulatory stories for medical device companies this week: Medical device makers face new obstacles to European approval; FDA panel narrowly OKs Cohera Medical's TissuGlu; FDA cuts fiscal 2015 user fees; Catching up with the FDA's 2014 guidance; FDA panel votes against EDAP's ultrasound prostate cancer ablation

Medical device makers face new obstacles to European approval

July 30, 2014 by Arezu Sarvestani

Medical device makers face new obstacles to CE Mark

UPDATE: FDA panel votes against Edap's ultrasound prostate cancer ablation

July 31, 2014 by Ingrid Mezo

An FDA advisory panel votes that French device maker Edap failed to demonstrate that its novel Ablatherm prostate cancer treatment is safe and effective.

UPDATE: FDA panel votes against Edap's ultrasound prostate cancer ablation

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FDA panel votes against EDAP's ultrasound prostate cancer ablation

July 30, 2014 by Ingrid Mezo

The FDA's expert advisory panel votes that French device maker EDAP failed to demonstrate that its novel Ablatherm prostate cancer treatment is safe and effective.

FDA panel rejects EDAP's ultrasound prostate cancer ablation

The FDA's Gastroenterology & Urology Devices panel today voted against recommending approval of EDAP's (NSDQ:EDAP) Ablatherm system for thermal ablation of the prostate gland to treat low-risk, localized prostate cancer.

Press Release: EDAP completes FDA inspection of manufacturing site

June 30, 2014 by MassDevice

Press Release: EDAP completes FDA inspection of manufacturing site

LYON, France -- EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, today announced that the U.S. Food and Drug Administration (FDA) concluded its routine inspection of EDAP's manufacturing site with no findings nor issuance of Form 483 observations.

EDAP creeps toward FDA approval with clean inspection

June 30, 2014 by Arezu Sarvestani

FDA inspectors find no issues at EDAP's manufacturing facility, putting the company one step closer to winning premarket approval for its ultrasound-based prostate cancer treatment.

EDAP creeps toward FDA approval with clean inspection

MGH researchers gain $30 million grant to build brain implants for treating mental illness | Medtech funding for the week of May 26, 2014

May 30, 2014 by MassDevice

Here's a look at some of the top funding stories for medical device companies this week: Mass. General gets $30M DoD grant to build brain implant for mental illness; Consano raises $3.9M to connect researchers with funders; M&A: Spectranetics prepares $200M offering to fund $230M AngioScore bid; EDAP outlines road to FDA approval for prostate cancer ultrasound therapy; Samsung dives into digital health with open platforms, $50M fund.

Mass. General gets $30M DoD grant to build brain implant for mental illness

May 28, 2014 by Arezu Sarvestani

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EDAP outlines road to FDA approval for prostate cancer ultrasound therapy

May 29, 2014 by Arezu Sarvestani

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 outlines road to FDA approval for prostate cancer ultrasound therapy
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