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 ...
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.
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.
American Hospital Association

FDA issues guidance on wellness products, clinical decision support software

The Food and Drug Administration today released two guidance documents; one related to low-risk wellness products (including ...
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 ...
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 ...
Packaging Gateway on MSN

FDA tightens cosmetic packaging rules

The US Food and Drug Administration has released new guidance focused on packaging technologies and tamper-resistant measures for cosmetic products.
STAT

FDA cuts may mean even less oversight of pet food

As a longtime dog owner, I assumed that each bag of my dogs’ commercial pet food was closely monitored by the federal Food and Drug Administration (FDA). It turns out I was wrong. More than 102 ...