Since 2019, companies that offer software and/or hardware devices aimed at promoting consumer health and wellness have had little more to rely on than a single short U.S. Food and Drug Administration ...

On January 6, 2026, the U.S. Food and Drug Administration (“FDA”) published revised final guidance documents on Clinical Decision Support Software (“Revised CDS Guidance”) and its General Wellness ...

As promised in its FDASIA report, the FDA has published a draft guidance document that aims to help those creating wellness devices and apps to better understand when their product (or their marketing ...

“The FDA process is time-consuming and costly. There’s no reason to do it if your product is not going to cross the line," said Ariel Seeley, a Morgan, Lewis & Bockius partner. The explosion in recent ...

Akron (Ohio) General Medical Center has entered into a joint venture with Signet Development, a developer of both public and private real estate projects, to commercialize the health system’s wellness ...

The Food and Drug Administration (FDA) updated its guidance on Tuesday to allow more wearables to fall into a general wellness category and skip the agency's expensive review process before going to ...

The U.S. FDA’s reissuance of the 2019 guidance for general wellness products seems to carve out new territory for makers of wearables that make modest claims regarding health, but anyone who was ...

If you’ve been to a hotel in the past year or so, you may have noticed something new. Nearly every hotel, from the casual roadside stop to the all-inclusive resort has all of a sudden started to focus ...