FDA Approves Abbott's First Wearable Device for Dual Ketone and Glucose Tracking - Abbott Laboratories (N

The U.S. Food and Drug Administration (FDA) on Tuesday approved Abbott Laboratories’ (NYSE:ABT) Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System for diabetes patients aged two and older.

The regulatory nod makes the device the first wearable in the U.S. to monitor ketone levels continuously. It also represents the first global system to track blood sugar and ketones simultaneously within a single unit.

Clinical Data And De Novo Pathway

The agency granted marketing authorization to Abbott via the De Novo pathway, which applies to new, low-to-moderate-risk medical devices.

The sensors alert users when ketones rise, replacing single-point urine or blood tests with continuous tracking.