Category: EDAP TMS SA
Here's a look at some of the top legal news stories for medical device companies this week: ArthroCare ex-CEO faces 30-year sentence for fraud; Shareholders sue Edap following FDA slip; Ex-sales rep wins class action status in lawsuit against Stryker; Another Covidien shareholder sues over Medtronic deal; Respiratory rivals ResMed, BMC each tally wins in Trade Commission ruling
Lawyers are looking for more shareholders to join a class action lawsuit against Edap TMS after an FDA expert panel vote against the company's ultrasound ablation technology.
A law firm is gathering support for a class action lawsuit against Edap TMS (NSDQ:EDAP), accusing leadership of misleading investors after an FDA expert panel panned the company's flagship ablation technology.
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
An FDA advisory panel votes that French device maker Edap failed to demonstrate that its novel Ablatherm prostate cancer treatment is safe and effective.
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.
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.
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.
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.