A new Food and Drug Administration AI tool that could speed up reviews and approvals of medical devices such as pacemakers ...

Terumo Interventional Systems has announced the early commercial availability of its FDA-approved Roadsaver Carotid Stent ...

Paradromics' Brain-Computer Interface has been tested briefly in a patient with epilepsy. Neuralink, Precision Neuroscience, and Synchron also have devices in the works. Other news looks at a ...

Recent FDA updates in the areas of cardiac intervention, hypertension and arrhythmia disorders expand the pool of available ...

The agency accused the Germany-based firm of selling multiple saliva-based ELISAs without appropriate marketing authorizations, among other violations.

There is a nearly five-year gap between when a new medical device receives FDA approval and is subsequently covered by ...

Moderna announced this weekend that the Food and Drug Administration approved its lower-dose Covid-19 vaccine for adults 65 ...

MINNEAPOLIS, May 22, 2025 /PRNewswire/ -- Phraxis Inc., a Minneapolis -based medical device company, marks a major milestone ...

The first at-home cervical cancer screening test has been approved by the Food and Drug Administration, according to the ...

The new test, known as the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, detects amyloid plaques through blood testing, a ...

U.S. officials have approved the first cervical cancer test that allows women to collect their own sample at home.

A Mexico City startup has achieved the Western Hemisphere's first SaMD regulatory approval for its proprietary AI-powered ...