Category: Abiomed Inc.
Here's a look at some of the top regulatory stories for medical device companies this week: FDA warns Cook Medical on 'nonconformance' issues; Abiomed jumps on FDA deal for Impella indication; Hansen Medical launches 3rd-gen Sensei surgical robot; Medtronic wins EU nod for Resolute Onyx stent
Abiomed says it's come to an agreement with the FDA on an indication for its flagship Impella 2.5 heart pump, and now expects to win pre-market approval early next year without a hearing before an FDA advisory panel.
Medtronic taps Dr. Elizabeth Nabel, president of Brigham & Women's Faulkner Hospital in Boston, for a seat on its board of directors.
Abiomed unveils new results from an IDE study of its Impella Right Percutaneous heart pump, reporting 73% survival in patients with right ventricular failure.
Abiomed (NSDQ:ABMD) got some Wall Street love today after releasing positive outcomes from a clinical trial of its minimally invasive Impella Right Percutaneous heart pump.
Researchers reported an overall 73% 30-day survival rate in the small study of patients with right ventricular heart failure, according to data Abiomed released during the Transcatheter Cardiovascular Therapeutics conference in Washington D.C.
GI Dynamics names ex-ATS Medical chief Michael Dale to replace Stuart Randle as CEO.
Abiomed says it struck a deal to extend the statute of limitations on any charges that might arise from a U.S. Justice Dept. probe of the marketing for its Impella heart pump and raised its estimate of the legal fees from the investigation.
Abiomed (NSDQ:ABMD) said it struck a deal with federal prosecutors to extend the tolling agreement on a probe of its marketing of its flagship Impella heart pump.
Abiomed said today that it expects the FDA to grant the pre-market approval application for its flagship Impella heart pump sooner rather than later, pushing up the timeline to March 2015.