The document follows the agency’s first digital health advisory meeting and a final guidance on postmarket updates to AI ...

Alleviant Medical announced that it received FDA investigational device exemption and breakthrough device designation for its ...

Both President Biden, and incoming President Trump, have made AI a top priority, and now the U.S. Food and Drug ...

The Medtronic Harmony transcatheter pulmonary valve system provides a minimally invasive alternative for congenital heart ...