Medtronic (NYSE:MDT) informed physicians last month of a problem with 48 of its cardiac rhythm management devices that’s prompting a Class I recall of the devices. The recall affects cardiac resynchronization therapy defibrillators and implantable cardioverter defibrillators that were “sent through a manufacturing sequence that introduced the potential for internal arcing during high-voltage charging, leading […]
Cardiac Rhythm Management
CMS mulls expanded MRI coverage for CRM patients
The Centers for Medicare & Medicaid Services is thinking about extending coverage for magnetic resonance imaging scans to patients with cardiac rhythm management devices after reviewing studies showing that MRI scans are safe. If finalized the decision would allow Medicare patients with implanted MR-conditional devices such as pacemakers or defibrillators to have their MRI scans […]
Sensor glitch prompts Boston Scientific warning on pacemakers
Boston Scientific (NYSE:BSX) last month warned physicians of a sensor glitch with some of its pacemakers that could lead to fainting episodes. In a December “Dear Doctor” letter, Marlborough, Mass.-based Boston Scientific said it received reports of “intermittent oversensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker […]
Abbott maintains Nanostim halt on docking button issue
Abbott (NYSE:ABT) said this month that it’s maintaining the worldwide halt on implantations of the Nanostim leadless pacemaker made by its St. Jude Medical subsidiary after reports surfaced of problems with the device’s docking button. The 3.6mm docking button is designed to allow the Nanostim device to be retrieved after implantation; it’s meant to connect with the […]
Appeals court tosses whistleblower suit against Biotronik
The plaintiff in a whistleblower lawsuit against Biotronik only gets one bite at the apple, a federal appeals court ruled last week in tossing the False Claims Act suit. The U.S. Court of Appeals for the Ninth Circuit upheld the dismissal of the second lawsuit brought by Max Bennett, a former Biotronik employee who alleged that the […]
FDA clears AliveCor’s KardiaBand ECG for Apple Watch
AliveCor said today that the FDA cleared its KardiaBand electrocardiogram device for the Apple Watch, designed to monitor for early signs of atrial fibrillation. First introduced in March 2016, KardiaBand is the first medical device accessory to be cleared by the federal safety watchdog for the Apple Watch, Mountain View, Calif.-based AliveCor said. It’s designed to display […]
LivaNova to deal CRM biz to MicroPort for $190m
LivaNova (NSDQ:LIVN) said today that it inked a deal to sell its cardiac rhythm management business to China’s MicroPort Scientific (HK:00853) for $190 million in cash. The companies, which are already partners in a CRM join venture in the People’s Republic, said the sale for LivaNova’s 900-worker CRM business is slated to close during the second quarter […]
EBR Systems pulls in $50m for wireless pacer
EBR Systems said yesterday that it raised $50 million to back a clinical trial for the wireless cardiac pacemaker it’s developing after winning CE Mark approval for a second-generation wireless transmitter. EBR’s device, which it calls wireless stimulation endocardially or Wise, uses a subcutaneous generator to wirelessly deliver ultrasound energy to a “pellet” implanted in the […]
Abbott wins MR-conditional label for Ellipse ICDs
Abbott (NYSE:ABT) said today that it won an MR-conditional label from the FDA for the Ellipse implantable cardioverter defibrillator it acquired along with St. Jude Medical early this year. The MR-conditional label applies to Ellipse and the Tendril MRI pacing lead and the Durata and Optisure high-voltage leads, the Chicago-area medical device giant said. “When […]
LivaNova mulls sale for CRM biz
LivaNova (NSDQ:LIVN) said today that it’s considering a sale for its cardiac rhythm management business, tapping Barclays to shop the $250 million operation to potential buyers. “As part of our ongoing efforts to position LivaNova for long-term success, we are sharpening our focus on the company’s areas of strength and market leadership. To that end, we […]
Abbott upgrades St. Jude Medical cardiac devices
Abbott (NYSE:ABT) said today that it’s upgrading the implantable pacemakers and defibrillators it acquired when it paid $25 billion for St. Jude Medical earlier this year, seeking to move beyond battery and cybersecurity issues that haver plagued it for a year. Last October St. Jude warned of a battery issue that could disable its high-voltage cardiac rhythm management devices, […]