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

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

The CEO of Flow Neuroscience has called out the US Food and Drug Administration (FDA) for market entry delays for clinically ...

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

In a new interview, the FDA commissioner had few answers on how Americans should think about Covid vaccines. Instead, he ...

The U.S. Food and Drug Administration cleared the first in vitro diagnostic device that tests blood to aid in diagnosing ...

Hologic is the latest partner to join the NEST Governance Committee which convenes a diverse group of leaders from across the medical device ecosystem-including regulatory agencies, industry, academia ...

Abbott Laboratories (NYSE:ABT) has received FDA approval today for its Tendyne™ transcatheter mitral valve replacement (TMVR) ...

As noted in our earlier alert, the FDA continues to face mounting internal pressure, ranging from staffing reductions and ...

Cyberattackers are well aware of medical device software weaknesses. Are you? RunSafe Security CEO Joe Saunders offers ...