U.S. Food and Drug Administration (FDA)

New FDA data shows more than 1200 medical devices have now been granted Breakthrough Device designation. With 164 approvals in fiscal year 2025 and continued strong activity across CDRH and CBER, the program remains a key pathway for accelerating innovative medical technologies.

The U.S. Department of Health and Human Services will launch a new study examining potential health effects of cellphone radiation, following the FDA’s removal of older web pages on the topic. The review aims to clarify scientific gaps amid evolving wireless technologies.

Fitness trackers and wellness wearables just got regulatory relief. The FDA's new draft guidance exempts low-risk consumer wellness devices from medical device scrutiny—unless they claim to be "medical grade." Here's what changed and what triggers stricter reviews.

The FDA can't protect patients without knowing shortages are coming. While the EU implemented mandatory device shortage reporting in 2025, the U.S. still has no requirements—leaving pediatric patients especially vulnerable to supply chain disruptions.

The FDA's medical device recall oversight is failing—and staffing shortages are to blame. GAO's December report shows nearly three-quarters of recalls exceeded termination targets during 2020-2024, with congressional recommendations for strategic staffing increases now on the table.

The FDA has updated its lists of medical devices with digital health technologies, including AI-enabled devices, AR/VR medical devices, and sensor-based digital health technology. These FDA-authorized device lists help healthcare providers understand the current digital health landscape and support informed use of advanced medical technologies in patient care.

The American Hospital Association is urging the FDA to establish regulatory standards for AI-enabled medical devices. The AHA recommends an AI policy framework balancing healthcare innovation with patient privacy protection. AI medical devices have grown significantly in healthcare settings, particularly in diagnostic imaging and radiology applications.

The U.S. Food and Drug Administration (FDA) is seeking public comment on how best to evaluate the performance of artificial intelligence (AI) technologies integrated within medical devices.

FDA device clearance times remain lengthy—averaging 140–175 days, far beyond the 90-day goal. Staffing cuts and process shifts fuel delays, while underused third-party review programs offer a potential shortcut for manufacturers seeking faster approvals.

The U.S. Food and Drug Administration (FDA) has now rescinded 2024 rules that required laboratory-developed tests (LTDs) to comply with the agency’s pre-marketing authorization requirements applicable to medical devices.