Medical Device and Diagnostic Industry (MD+DI)

FDA's Deregulation of Wellness Devices Is a Slippery Slope

This week in Pedersen's POV, our senior editor argues against FDA's huge shift in digital health — made without public ...
Fierce Healthcare

FDA paves way for more consumer wearables to hit the market, eases regulation of AI-enabled devices

The Food and Drug Administration (FDA) updated its guidance on Tuesday to allow more wearables to fall into a general ...
HealthLeaders Media

FDA relaxes rules for wearable health devices

The FDA has announced that it will relax portions of its regulatory framework governing wearable health devices, a move the agency says is designed to encourage innovation and expand consumer access ...
Medical Marketing & Media

3 regulatory issues for pharma marketers to keep an eye on in 2026

While the Trump administration remains unpredictable, some pharma experts are optimistic that the regulatory landscape will ...

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 ...
Medscape

Should The FDA Require 'Clinical Licensure' of AI Tools For Doctors?

A new proposal in JAMA Internal Medicine suggests that the FDA should create an approval pathway for medical AI tools that parallels how physicians are trained and licensed.
News Medical

Learn to navigate regulatory pathways for SaMD

Navigating the SaMD regulatory pathways is one of the most complex yet important aspects of product development for medical technology startups. Startups in this field are required to meet local ...