Legacy medical devices face growing scrutiny as regulators push for stronger cybersecurity, transparency and risk management.

The U.S. Food and Drug Administration (FDA) recently finalized its guidance document, Computer Software Assurance for Production and Quality System Software, for software used in device production and ...

The FDA has entered into the federal register a new draft guidance pertaining to "software as a medical device" (SaMD). The guidance is presented as representing the FDA's current thinking on ...

This morning the FDA released two guidance documents relating to the regulation of various digital health software devices. The first is a draft guidance outlining categories of clinical decision ...

The U.S. FDA issued a pair of final guidances this week, including one that outlines the criteria for authorizing emergency use of unapproved in vitro diagnostic tests during future public health ...

The FDA has released a new draft guidance that outlines how developers should evaluate software used for the clinical management of patients. This software, called “software as a medical device,” is ...

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...

Integrating AI into medical devices brings the industry a new level of innovation. The benefits can help both providers and patients but also introduce more risk. AI’s application in any technology is ...

Add Yahoo as a preferred source to see more of our stories on Google. Ōura launched the Oura Ring 4 in October 2024. The company has partnered with Dexcom to integrate its smart ring technology with ...