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

The US Food and Drug Administration (FDA) has granted breakthrough device designation to BiVACOR’s titanium Total Artificial ...

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 ...

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 ...

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

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

Vivani Medical is developing GLP-1 subdermal implants that aim to provide a consistent therapeutic dose for six months, and ...

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