With medical devices, recalls are not always what they seem. In some recalls, including some of the most serious, the FDA and the manufacturers let doctors and hospitals continue to use the devices.

Consumers Union recommends that the FDA: Require that implants and other "life-sustaining" devices be tested ... connect them to the heart. There have been two major recalls, in 2007 and ...

Abbott Laboratories has announced that its implantable heart device, MitraClip, has not been recommended for approval by reviewers at the US Food and Drug Administration. Clinical trials ...

Two artificial intelligence (AI) algorithms designed to diagnose people with heart rhythm abnormalities have been approved by the FDA ... implantable cardiac monitors like its Linq II device ...

VVeno Medical (Nasdaq:NVNO) announced three-year outcomes for its heart valve that it aims to submit to the FDA this year.

Patients awaiting a heart transplant are often implanted with an ... and funding for pediatric heart devices. The network is working with the U.S. Food and Drug Administration (FDA) to expand ...

The SOLVE-CRT trial has delivered promising results for heart ... devices—pacemakers, ICDs, or CRTs—using a subcutaneous ultrasound Transmitter to power an ultra-compact Electrode implanted ...

Inspectors found ICU Medical made multiple changes to infusion pumps without submitting premarket notifications.

The US Food & Drug Administration has approved EBR System’s leadless pacemaker WISE, the only device able to deliver left-ventricle stimulation. Don't miss out on the headlines from Stockhead.