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