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.

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 ...

The US Food and Drug Administration (FDA) has approved the expansion of BiVACOR’s early feasibility study evaluating its titanium total artificial heart (TAH) to additional participants.

The FDA has cleared a device aimed at improving access to the heart’s outer surface for diagnostic and therapeutic interventions without the use of an exposed needle. The device, called ViaOne ...

Medline Industries led recalls in three categories, while Philips Medical Systems Nederland B.V. had the most devices ...

Omniasecure, which was authorized for placement in the heart’s right ventricle, is the world’s smallest defibrillation lead, ...

Carmat is preparing to commence implants ... tumour. "FDA conditionally approves second cohort of Carmat’s artificial heart study" was originally created and published by Medical Device Network ...

BrightHeart has its second FDA clearance for updates to its platform, an AI-powered digital screening tool for congenital ...

Medtronic (NYSE: MDT) announced that it received FDA approval for its OmniaSecure defibrillation lead for right ventricle placement.

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 ...