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EDAP TMS SA

FDA wants more from Edap on Ablatherm de novo bid

July 21, 2015 By Brad Perriello

Edap (NSDQ:EDAP) today said the FDA wants more on its bid for de novo approval of its Ablatherm HIFU prostate cancer device, saying it needs to address 4 points raised by the federal safety watchdog before the process can resume. The news, following the French firm’s March announcement that it would abandon its pre-market approval application, […]

Filed Under: Food & Drug Administration (FDA), Urology Tagged With: EDAP TMS SA, Prostate

NuVasive shuffles the deck | Personnel Moves

July 14, 2015 By Fink Densford

NuVasive Inc. (NSDQ:NUVA) announced a flurry of new executive assignments yesterday as it reorganizes its leadership team under new CEO Gregory Lucier, who took over the position in May from ousted Alex Lukianov. NuVasive 14-year vet Pat Miles will stay on as COO and president, a position he was appointed to earlier this year, NuVasive said. […]

Filed Under: Business/Financial News Tagged With: ControlRad, EDAP TMS SA, Entellus Medical Inc., Fujifilm, Lantheus Medical Imaging, Mauna Kea Technologies, Nuvasive, Personnel Moves

Ex-Biomet CEO Binder is Immucor’s new chief exec | Personnel Moves

July 6, 2015 By Brad Perriello

Immucor said it named Jeffrey Binder, who led Biomet until its $13.34 billion merger with Zimmer (NYSE:ZMH), to be its new chairman, president & CEO. Binder replaces William Hawkins, the former Medtronic (NYSE:MDT) chief executive who took the reins at Immucor in 2011. Hawkins will assume the role of lead director on Immucor’s board, that company said. Immucor is […]

Filed Under: Business/Financial News Tagged With: becton dickinson, EDAP TMS SA, Essex Woodlands Health Ventures, Immucor Inc., Insulet, Personnel Moves, RaySearch Laboratories

Edap, GE Healthcare join French-backed $45m liver cancer consortium

April 6, 2015 By Val Kennedy Leave a Comment

Edap, GE Healthcare join $45m liver cancer consortium

Filed Under: News Well, Oncology, Ultrasound Tagged With: Bpifrance, EDAP TMS SA, GE Healthcare

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

March 9, 2015 By Brad Perriello Leave a Comment

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

Filed Under: Food & Drug Administration (FDA), News Well, Pre-Market Approval (PMA), Regulatory/Compliance, Urology Tagged With: De Novo Clearance, EDAP TMS SA, Men's Health

Edap shares jump on Health Canada nod for prostate device

January 9, 2015 By Brad Perriello Leave a Comment

Edap shares jump on Health Canada nod for prostate device

Filed Under: News Well, Regulatory/Compliance, Urology Tagged With: EDAP TMS SA, Health Canada, Prostate

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

November 11, 2014 By MassDevice Leave a Comment

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

November 6, 2014 by Brad Perriello

Filed Under: Food & Drug Administration (FDA), News Well, Regulatory/Compliance Tagged With: Cardiovascular Systems Inc., Dexcom, EDAP TMS SA

FDA: Edap’s Ablatherm prostate cancer device ‘not approvable’

November 6, 2014 By Brad Perriello Leave a Comment

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

Filed Under: Food & Drug Administration (FDA), News Well, Pre-Market Approval (PMA), Regulatory/Compliance, Urology Tagged With: EDAP TMS SA, Prostate

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

September 1, 2014 By MassDevice Leave a Comment

ArthroCare ex-CEO faces 30-year sentence for fraud

August 25, 2014 by Arezu Sarvestani

ArthroCare ex-CEO faces 30-year sentence for fraud

Filed Under: Legal News, News Well Tagged With: ArthroCare Corp., BMC Medical, Covidien, EDAP TMS SA, Legal Roundup, ResMed Inc., Stryker

Shareholders sue Edap following FDA slip

August 27, 2014 By Arezu Sarvestani

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.

Filed Under: Legal News, News Well, Oncology Tagged With: Ablation, EDAP TMS SA, Prostate

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 Leave a Comment

Medical device makers face new obstacles to European approval

July 30, 2014 by Arezu Sarvestani

Medical device makers face new obstacles to CE Mark

Filed Under: Food & Drug Administration (FDA), News Well, Regulatory/Compliance Tagged With: Cohera Medical Inc., EDAP TMS SA, European Commission

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