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 ...

ReShape Lifesciences (RSLS) on Tuesday announced that its Quality Management System (QMS) and entire commercial portfolio 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.

Health technology company Cardiex has achieved an important milestone, receiving Therapeutic Goods Administration (TGA) ...

The FDA rolled out its agency-wide AI tool weeks ahead of schedule, on Monday offering a look at the technology and how it ...