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

The U.S. Food and Drug Administration says it will ease regulatory requirements for certain consumer wearable health devices.

FDA plans limited regulation of wearable medical devices, boosting Apple, Fitbit, Oura stocks as 50% of Americans use fitness ...

The "The EU Regulations for Digital Medical Devices with AI Components - A Basket Full of Requirements - What Does a Manufacturer Need to Consider? (Dec 9, 2025)" training has been added to ...

Digital biomarkers – data collected by wearable digital medical devices – can be used to inform the development of new drugs and medical devices and to evaluate their effectiveness. Listen as Jordan ...

From wearables for health monitoring and self-care apps, to machine learning analysis of medical images, the potential of digital technologies to revolutionise healthcare has commanded many headlines.

MILAN & WASHINGTON--(BUSINESS WIRE)--Following the formation of the European DTx Policy Coalition by Healthware Group and the Digital Therapeutics Alliance (DTA) in June 2022, the joint team presented ...

Health technology assessment (HTA) is a formidable task across drug development, medical device innovation, and digital health solutions. To help with this task, the European HTA Regulation entered ...

Digital health exploded during and after the COVID-19 pandemic, and with it came some real concerns about data privacy, security, and ethics in connected health devices, said Bethany Corbin, managing ...