IceCure Medical (NASDAQ:ICCM) said an FDA advisory committee will meet on Nov. 7 to discuss its De Novo Classification ...

The change applies to qualitative and quantitative hepatitis B virus antigen, antibody, and nucleic acid assays that are used to detect acute and chronic infections.

Apple has received authorization from the U.S. Food and Drug Administration (FDA) to transform its second-generation AirPods ...

At Apple’s recent “It’s Glowtime” event, the spotlight was on the iPhone 16, but a surprising announcement came from a ...

As laboratories navigate the evolving landscape of Laboratory Developed Tests (LDTs), the FDA’s phased approach to regulation ...

The DeepView ® System wound healing assessment platform empowers clinicians at all levels with the insights necessary for timely and informed treatment decisions. The use of the DeepView ® System aims ...

SoClean’s Bob Wilkins says the company is trailblazing a new path for bacterial reduction devices for CPAP hoses and masks ...

Biomedicines’ generative artificial intelligence (AI) platform to discover and develop protein therapeutics for multiple ...

The University of Maryland spinout said it plans to launch a point-of-care urinary tract infection test by 2025, followed by three more tests by 2028.

U.S. Senator Bernie Sanders is set to question Novo Nordisk CEO Lars Jorgensen on Tuesday over the drugmaker's prices for its ...

Sen. Bernie Sanders said on Tuesday he had commitments from the nation's top pharmacy benefit managers that they would expand ...

Roche's diversified portfolio and ongoing GLP-1 developments offer decent upside with limited downside. Read more about RHHBY ...