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’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 ...

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

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 ...

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 ...

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 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 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 ...

“The FDA process is time-consuming and costly. There’s no reason to do it if your product is not going to cross the line," said Ariel Seeley, a Morgan, Lewis & Bockius partner. The explosion in recent ...

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 ...

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 U.S. Food and Drug Administration says certain AI-enabled "low-risk" health devices and clinical decision support software won't face agency's regulatory scrutiny. (Image: FDA) New artificial ...