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 ...

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 ...

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 (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- ...