Category: Cardiac Assist Devices
HeartSine's recall of Samaritan defibrillators gets Class I status from the FDA over concerns that battery defects could lead to patient injury or death.
The FDA gave HeartSine's Samaritan defibrillator recall Class I status over concerns that battery issues could lead to patient injury or death.
The Samaritan 300/300P public access defibrillators, which were found to intermittently turn off and on, may be unable to deliver therapy during a cardiac event due to the battery defects.
Shareholders of medical device company Abiomed filed a purported class action lawsuit, accusing the company of inflating its stock price with rosy predictions for its flagship Impella 2.5 heart pump.
Shareholders of Abiomed (NSDQ:ABMD) filed a lawsuit seeking class action status, accusing the medical device company of inflating its share price with falsely rosy predictions for its flagship Impella 2.5 heart pump.
Abiomed wins FDA approval for an investigational device exemption trial of its Impella RP heart pump for right-side percutaneous cardiac assistance.
Abiomed (NSDQ:ABMD) said it's won a nod from the FDA to run a clinical trial of its new heart pump for right-side cardiac assistance, the Impella RP.
Abiomed shares regain some value on news of new reimbursement codes from Medicare for its Impella heart pump.
Abiomed (NSDQ:ABMD) said the Centers for Medicare & Medicaid Services approved a trio of reimbursement codes for its Impella heart pumps, allowing ABMD shares to regain some of the roughly 30% investors pared from the stock this week.
California-based medical device company CardioKinetix wins CE Mark approval for all 8 sizes of its Parachute ventricular partitioning device, designed to provide percutaneous ventricular restoration therapy.
California-based medical device company CardioKinetix landed CE Mark approval in the European Union for the full suite of its Parachute ventricular partitioning devices, including 8 sizes of the device designed to provide support to weakened heart muscles. .
Abiomed unveils clinical updates on its Symphony device following the 2nd successful human use in Canada, showing positive results over 28 days.
Massachusetts medical device company Abiomed (NSDQ:ABMD) reported positive clinical results for the 1st Canadian patients implanted with the company's Symphony device, a minimally invasive pump designed to slow the progression of heart failure and help the heart remodel.
Medical device company Abiomed says the chances are slim that Medicare will grant a national coverage decision for its Impella heart pump.
Abiomed (NSDQ:ABMD) said it doesn't believe that the Centers for Medicare & Medicaid Services is likely to bestow a national coverage decision for its Impella heart pump.