On Tuesday, the U.S. Food and Drug Administration approved a device to continuously monitor blood sugar and ketone levels in people with diabetes.

The FDA authorized Abbott’s Libre Duo 10 Day on August 25, the first U.S. wearable to continuously monitor both ketones and glucose.

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 ...

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 ...

It’s no question that technology is expanding at a rapid pace, impacting devices in all fields, from manufacturing to medicine. When new developments come to fruition in the medical space, companies ...

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 ...

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 ...

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 ...

The Food and Drug Administration on Tuesday released two final guidance documents that would loosen regulations for certain types of wellness and software products. FDA Commissioner Marty Makary ...

Dec 3 (Reuters) - Niche fitness-tracking firms such as WHOOP are coming under increased regulatory scrutiny as technological advances blur the lines between wearable and medical devices, exposing them ...

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 ...