In a safety communication dated December 16 posted to the site of the FDA, the agency stated: “The U.S. Food and Drug Administration is alerting patients, caregivers, and health care providers about ...

Boston Scientific has recalled its Accolade pacemaker devices due to a manufacturing issue that could cause the devices to enter safety mode, requiring replacement. The FDA has classified the recall ...

Medical device major Boston Scientific Corporation (BSX) recently launched its Accolade family of pacemakers in the European market, after winning the CE (Conformité Européenne) Mark approval for the ...

BRUSSELS, March 5 (Reuters) - U.S. medical device maker Boston Scientific Corp's German arm is liable for the cost of operations to replace potentially defective pacemakers, Europe's top court ruled ...

TUESDAY, Feb. 25, 2025 (HealthDay News) -- Boston Scientific has issued a recall of Accolade pacemaker devices, according to a safety communication from the U.S. Food and Drug Administration. The ...

Boston Scientific has announced it has received FDA approval its INGENIO and ADVANTIO pacemakers and INVIVE cardiac resynchronization therapy pacemakers, according to a news release. The INGENIO and ...

Boston Scientific (NYSE:BSX) announced Saturday that its pivotal clinical trial for the modular cardiac rhythm management (CRM) system, which comprises its EMPOWER leadless pacemaker, met all safety ...

Guidant, a subsidiary of Natick, Mass.-based Boston Scientific, has agreed to pay $9.25 million to settle False Claims Act charges over the company’s alleged cost inflation for pacemakers and ...

Medtronic was the only manufacturer of a leadless pacemaker in the U.S. market in the years after it won approval for its Micra device in 2016. While leadless pacemakers were designed to prevent lead- ...