A Type B meeting between the FDA and Plus Therapeutics offered clarity and direction for the next steps in development of ...

Torous noted that over the summer, a company called WHOOP received an FDA warning letter over a product that could measure ...

Diabeloop receives FDA 510(k) clearance for DBLG2, an Automated Insulin Delivery algorithm in an App: a strategic ...

The USDA is kicking off the new year by rolling out new dietary recommendations aimed at making healthy eating simpler.

A new year is upon us, and FDA Commissioner Marty Makary is still staring down many of the same challenges that faced his ...

FDA plans limited regulation of wearable medical devices, boosting Apple, Fitbit, Oura stocks as 50% of Americans use fitness ...

Company Transitions from Infrastructure Buildout to Active Market Execution as Expanded 510(k) Review Enters Final ...

Lumipulse, a non-invasive, blood test can help diagnose Alzheimer’s disease in adults aged 55 and above by measuring the ...

FDA commissioner Marty Makary revealed at the 2026 CES trade show in Las Vegas that low-risk devices will face less ...

The FDA will ease regulation of digital health products, aiming to deregulate AI and promote its widespread use.

The U.S. Food and Drug Administration says it will ease regulatory requirements for certain consumer wearable health devices.

In summary, a buyer today should look for a partner who can meet design demands, maintain international safety certifications (CE, FDA), support OEM/ODM customisation, handle sports-application lenses ...