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

According to the FDA’s public database, since the start of this year, the agency has issued only two de novo medical device ...

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

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 ...

Company on track to commence U.S. clinical studies in 2025 to support a De Novo application for FDA approvalTHE WOODLANDS, TX, April 08, 2025 ...

March 28, 2025 /PRNewswire/ -- Today, Visby Medical™, a leading innovator in medical diagnostics, announced that the U.S. Food and Drug Administration (FDA) has granted De Novo authorization for ...

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

CTSO READ THE FULL CTSO RESEARCH REPORT Update on the DrugSorb-ATR Regulatory Process Management reiterated that their De Novo DrugSorb-ATR submission continued to be in interactive review with FDA, ...

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 ...