FDA revised guidance documents for low-risk wellness products and clinical decision software, clarifying regulatory ...

A key section of the recently passed 21st Century Cures Act explained to the US Food and Drug Administration (FDA) which categories of software should be exempt from medical device regulations. Most ...

Software-based medical devices are integral to healthcare. To enter the marketplace, a company must successfully navigate and comply with applicable national and international regulatory requirements.

The FDA issued Zoll Medical a warning letter outlining quality system regulation violations and violations of medical device ...

A recently released analysis report from the Deloitte Center for Government Insights that examines the US’s current and proposed software as a medical device (SaMD) regulatory landscape, and includes ...

Basics and Beyond - Keeping Up with FDA Medical Device Submission Programs and Pilots” session MEDevice Boston 2026 on August ...

Mario covers technology in health care, including FDA regulation of artificial intelligence; how Medicare pays for health tech; the use of AI in clinical care; mental health chatbots; and consumer ...

The Food and Drug Administration has told Whoop that it must get its wearable blood pressure tool approved as a medical device, but the Boston tech company is refusing to submit it to the agency for ...

“Don’t fear the Reaper,” the rock band Blue Öyster Cult famously advised. For many digital health companies, the Food and Drug Administration’s recently revised guidances affecting the classification ...