Category: EDAP TMS SA
Edap says it's bailing out on the pre-market approval bid for its Ablatherm prostate cancer device and plans to seek de novo clearance from the FDA instead.
Edap shares gain today after it reveals a nod from Health Canada for its Focal One HIFU device for treating prostate cancer.
Here's a look at some of the top regulatory stories for medical device companies this week: Diabetes: FDA OKs new 'artificial pancreas' software for DexCom glucose meter; FDA: Edap's Ablatherm prostate cancer device 'not approvable'; Cardiovascular Systems wins CE Mark for Stealth 360 peripheral artery device
Edap TMS says the FDA sent it a 'not approvable' letter for its Ablatherm prostate cancer treatment, but the French company has until April 2015 to update its pre-market approval application.
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