Category: EDAP TMS SASyndicate content

Edap bails on Ablatherm PMA, to seek de novo clearance from FDA

March 9, 2015 by Brad Perriello

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 bails on Ablatherm PMA, to seek de novo clearance from FDA

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Edap shares jump on Health Canada nod for prostate device

January 9, 2015 by Brad Perriello

Edap shares gain today after it reveals a nod from Health Canada for its Focal One HIFU device for treating prostate cancer.

Edap shares jump on Health Canada nod for prostate device

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FDA approves 'artificial pancreas' algorithm for continuous glucose monitor | Regulatory news for the week of November 10, 2014

November 11, 2014 by MassDevice

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

Diabetes: FDA OKs new 'artificial pancreas' software for DexCom glucose meter

November 6, 2014 by Brad Perriello

FDA: Edap's Ablatherm prostate cancer device 'not approvable'

November 6, 2014 by Brad Perriello

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.

FDA: Edap's Ablatherm prostate cancer device 'not approvable'

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ArthroCare executives found guilty of defrauding investors | Medtech legal news for the week of September 1, 2014

September 1, 2014 by MassDevice

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

ArthroCare ex-CEO faces 30-year sentence for fraud

August 25, 2014 by Arezu Sarvestani

ArthroCare ex-CEO faces 30-year sentence for fraud

Shareholders sue Edap following FDA slip

August 27, 2014 by Arezu Sarvestani

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.

Shareholders sue Edap following FDA slip

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.

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