The Food and Drug Administration (FDA) updated its guidance on Tuesday to allow more wearables to fall into a general ...
The U.S. Food and Drug Administration says it will ease regulatory requirements for certain consumer wearable health devices.
FDA commissioner Marty Makary revealed at the 2026 CES trade show in Las Vegas that low-risk devices will face less ...
The chief medical officer is interested in an easier path to market for health screening features in wearable devices.
A new proposal in JAMA Internal Medicine suggests that the FDA should create an approval pathway for medical AI tools that parallels how physicians are trained and licensed.
“It would not be surprising to not see new FDA guidance documents issued for some period of time,” said David Larwood, CEO of Valley Fever Solutions, about the potential impact of the US Food and Drug ...