Becker's Hospital Review

FDA may allow medical companies to promote drugs, devices for off-label uses

The Food and Drug Administration is in the midst of a two-day hearing to discuss whether drug companies and devicemakers should be allowed to promote unapproved uses of medical products to physicians, ...

Apple's App Store will show if an app is classified as a regulated medical device

The further Apple dives into medical technology, the more it will have to deal with regulators. Now, the App Store will label ...
Medscape

Off-Label Drug, Medical Device Use Discussed at FDA Hearing

The US Food and Drug Administration (FDA) held a 2-day public hearing this week to solicit input about the marketing and use of medications and medical devices for off-label use. It is fairly common ...
MD&M East

To Be or Not to Be (a Medical Device): FDA Vs. WHOOP

On July 14, 2025, FDA issued a warning letter to WHOOP, Inc., notifying the company that its marketing of Blood Pressure Insights (BPI) was neither cleared nor approved. FDA stated that BPI qualifies ...
Seeking Alpha

SeaStar Medical Finalizes FDA Labeling Requirement for QUELIMMUNE, Paving the Way for First Commercial Sales as Humanitarian Use Device

DENVER, July 03, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage medical device company developing proprietary solutions to reduce the consequences of ...
Forbes

FDA Medical Device Cybersecurity And SBOMs: Compliance And Potential

When the Federal Drug Administration (FDA) updated the provisions for medical device cybersecurity, one of those required the development of a software bill of materials (SBOM). It’s now mandatory for ...