JD Supra

FDA enforcement against SeniorLife, Whoop signal new line in the sand for AI health apps - DigiCure: Legal insights at the intersection of Technology and Life Sciences & Health ...

The U.S. Food and Drug Administration (FDA) has issued two significant warning letters in recent months—one to SeniorLife Technologies Inc. and another to Whoop—that together mark a clear escalation ...
Fierce Pharma

AstraZeneca, Daiichi beat Gilead to first-line TNBC with FDA nod for Datroway

The TROP2 battle in first-line triple-negative breast cancer has officially kicked off. | A three-way battle among TROP2 ADCs ...
RAPS

FDA revises more than 800 PSGs in line with ICH M13A

The US Food and Drug Administration (FDA) on Thursday published revised draft product-specific guidances (PSGs) for immediate-release solid oral generic drugs deemed to be low risk that will no longer ...
MobiHealthNews

FDA clarifies the line between wellness and regulated medical devices

As promised in its FDASIA report, the FDA has published a draft guidance document that aims to help those creating wellness devices and apps to better understand when their product (or their marketing ...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

The FDA and WHOOP Debate Challenges the Line Between Wellness Products and Medical Devices

In July 2025, the U.S. Food and Drug Administration (FDA) issued a warning letter to WHOOP, Inc. (WHOOP), asserting that the company is marketing its wearable blood pressure product, or Blood Pressure ...