Newswise — In early January, the U.S. Food and Drug Administration said that it would limit the regulation of wearable devices and software designed for health and wellness. The guidance extends ...

The FDA’s January 2026 update to its “General Wellness: Policy for Low Risk Devices” guidance materially expands the types of wearable features that may avoid medical device regulation. Signaling a ...

Add Yahoo as a preferred source to see more of our stories on Google. Whoop's wearable devices measure metrics including sleep, heart rate and blood pressure. The company received a warning letter ...

Austin, Dec. 03, 2025 (GLOBE NEWSWIRE) -- According to SNS Insider, The Wearable Drug Delivery Devices Market is projected to reach USD 34.10 billion by 2032 from USD 19.56 billion in 2024, growing at ...

The Food and Drug Administration has selected the first participants for an innovation challenge for home devices that could ...

The FDA has approved the Libre Duo 10 Day CGM wearable It can continuously measure both ketones and blood sugar levels It’s worn by diabetics as a continuous glucose monitor (CGM) The US Food and Drug ...

FDA updated its General Wellness policy to clarify and take a step back from previous positions on health and wellness technology. The Food and Drug Administration (“FDA”) unexpectedly updated its ...

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 ...

Aug. 25 (UPI) --On Tuesday, the U.S. Food and Drug Administration approved a device designed to continuously monitor both blood sugar levels and ketone levels in people with diabetes. The Libre Duo 10 ...

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 ...

The FINANCIAL — The U.S. Food and Drug Administration today authorized the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System for people aged 2 years and older living with diabetes. The ...