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

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 ...

SCOTTSDALE, AZ, UNITED STATES, June 3, 2025 /EINPresswire.com/ -- Blue Goat Cyber, a leading authority in medical device cybersecurity and FDA compliance strategy, proudly announces its sponsorship of ...

The FDA has granted a breakthrough device designation to the BiVACOR Total Artificial Heart. Made of titanium, the device uses a magnetically levitated rotor to pump blood in adult patients with ...

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 ...

UK-based medical device company CMR Surgical has put itself up for sale at a valuation of up to $4 billion, the Financial Times reported on Tuesday, citing sources familiar with the matter.

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

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

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