FDA commissioner says non-medical-grade wearable data exempt from regulation

FDA announces wearable devices providing non-medical info won't face regulation, offering clarity on digital health ...

US FDA to limit regulation of health and fitness wearables, commissioner says

The U.S. Food and Drug Administration said on Tuesday that it will limit regulation of wearable devices and software designed ...
EconoTimes

FDA Limits Regulation of Wearable Devices and Wellness Software, Boosting Health Tech Industry

The U.S. Food and Drug Administration (FDA) announced on Tuesday that it will limit regulatory oversight of wearable devices ...
Becker's Hospital Review

FDA: Nonmedical wearable health data won’t face oversight

FDA nonmedical wearable health data devices providing general health info will not face regulation, clarifying guidance for tech companies and investors.

FDA Approves First At-Home Brain Stimulation Device For Depression

Swedish neurotech startup Flow Neuroscience has secured FDA approval for the first brain stimulation device for home use in ...
STAT

FDA announces sweeping changes to oversight of wearables, AI-enabled devices

The FDA will ease regulation of digital health products, aiming to deregulate AI and promote its widespread use.
MD&M East

Embrace FDA Regulations: Turn Medtech Compliance Into Your Competitive Edge

Many Medtech startups view FDA and similar regulatory bodies as a roadblock. Something that is there to get in their way, slow them down, and cost them a fortune. Smart companies see regulations as an ...
Opinion

AI Integration In MedTech Devices And Diagnostics: Regulation And Investment Opportunities

GE HealthCare Technologies Inc. (NYSE: GEHC) leads with 100 FDA-approved AI devices, concentrating heavily on imaging and diagnostics. Their CleaRecon DL technology sharpens cone-beam CT images using ...