Opinion: The Food and Drug Administration's updated guidance on wellness devices will help ensure that products are appropriately positioned in the market—while staying away from unsupported, ...

With more and more sensors being crammed into the consumer devices that many of us wear every day, the question of where medical devices begin and end, and how they should be regulated become ever ...

Instead of making life easier for medical device companies, the FDA’s new wearables guidance makes the market more complex.

Vibroacoustic Products Listed as Class I Medical Devices; Red Light Therapy Products Listed as Class II Medical Devices ...

One day this summer, Pat McAfee, the former NFL punter turned ESPN personality, interviewed New York Jets cornerback Sauce Gardner about his partnership with Q-Collar, the only medical device cleared ...

Like many in the medtech industry, I was initially optimistic when FDA announced its revised guidance on wearable wellness devices. For years, the industry has called for clearer, more predictable ...

On July 14, 2025, FDA issued a warning letter to WHOOP, Inc., notifying the company that its marketing of Blood Pressure Insights (BPI) was neither cleared nor approved. FDA stated that BPI qualifies ...

The LifeVac team received numerous warnings for not completing a required review process before distributing the device, the ...

Americans cannot rely on the Food & Drug Administration (FDA) to guarantee that medical devices are safe, and a recent Government Accountability Office (GAO) report only strengthens that conclusion.