U.S. Food and Drug Administration approvals of life-changing, high-risk medical devices reportedly slowed to a 10-year low ...

Shockwave Medical has commenced the IDE study of the Javelin Coronary IVL Catheter for treating calcified coronary lesions.

The US Food and Drug Administration (FDA) has authorised the first at-home PCR STI test for chlamydia, gonorrhoea, and ...

"I really enjoyed my work. I loved the mission of trying to keep these medical devices safe for everybody who's gonna use them." Classifications for reported "de novo" medical devices, which tend ...

According to the FDA’s public database, since the start of this year, the agency has issued only two de novo medical device clearances. That includes the Jan. 17 green light of Myocene’s ...

The FDA has granted a de novo clearance to a vibrating mattress pad for hospital bassinets, designed to stimulate rhythmic ...

Company on track to commence U.S. clinical studies in 2025 to support a De Novo application for FDA approval THE WOODLANDS, ...

Johnson & Johnson MedTech‘s  Medical announced today that it initiated a study evaluating its Javelin coronary IVL catheter.

Visby Medical™, a leading innovator in medical diagnostics, announced that the U.S. Food and Drug Administration (FDA) has ...

The FDA reviewed this test under the FDA’s De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk ...

After 12 years of development, our device delivers rapid ... The granting of this De Novo marketing authorization positions Visby Medical for significant expansion into the at-home diagnostics ...

Apple Inc. (NASDAQ: AAPL) is reportedly working on an AI-driven health coach, under the codename Project Mulberry, as a ...