Abbott Receives FDA Authorization For Dual Glucose-Ketone Sensor
(RTTNews) - Abbott (ABT) announced that the U.S. FDA has authorized its Libre Duo 10 Day system, the world's first dual glucose ketone sensing technology for people living with diabetes.
Diabetic ketoacidosis (DKA) is a serious complication that can develop rapidly when the body lacks sufficient insulin, leading to dangerously high ketone levels. Hospital admissions for DKA have risen 55% over the past decade, and early symptoms are often mistaken for common infections, delaying treatment.
Libre Duo 10 Day is a first-of-its-kind biowearable that continuously monitors glucose while simultaneously detecting rising ketones in the background. The device provides real-time visibility into glucose levels for daily diabetes management and alerts users to potential DKA emergencies without adding extra burden.
The system integrates with Abbott's latest-generation Libre app and digital health ecosystem, and is designed for compatibility with leading automated insulin delivery systems. It received De Novo authorization after securing breakthrough device designation, marking it as the first to meet both FDA's integrated continuous glucose monitoring (iCGM) and integrated continuous glucose and ketone monitoring (iCGK) standards.
Abbott plans to launch Libre Duo 10 Day in the United States later this year.
ABT has traded between $81.97 and $137.49 over the past year. The stock closed Tuesday's trading at $116.13, down 0.46%. In pre-market trading the stock is at $115.30, down 0.70%.
