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, […]
NuVasive shuffles the deck | Personnel Moves
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. […]
Ex-Biomet CEO Binder is Immucor’s new chief exec | Personnel Moves
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 […]
Edap, GE Healthcare join French-backed $45m liver cancer consortium
Edap bails on Ablatherm PMA, to seek de novo clearance from FDA
Edap shares jump on Health Canada nod for prostate device
FDA approves ‘artificial pancreas’ algorithm for continuous glucose monitor | Regulatory news for the week of November 10, 2014
FDA: Edap’s Ablatherm prostate cancer device ‘not approvable’
