The U.S. Food and Drug Administration (FDA) on Tuesday approved Abbott Laboratories’ ABT Libre Duo 10 Day Continuous Dual ...

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 the first dual glucose and ketone monitoring system, offering continuous real-time tracking for patients 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 ...

In terms of who can use it, the Libre Duo 10 Day wearable has been approved for use by people aged two or over who are living ...

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 ...

People with diabetes can now get an early warning when a dangerous complication starts to build in their bodies.

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 ...

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 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 ...