FDA Approval for Abbott's World's First Dual-Sensor Device for Diabetes Patients
Abbott has received approval from the U.S. Food and Drug Administration for the world's first dual-sensor system that helps prevent diabetic ketoacidosis by tracking ketone levels in diabetes patients.
Abbott announced that it has received official approval from the U.S. Food and Drug Administration for the Libre Duo 10 Day system, which monitors diabetes patients' glucose levels and helps prevent diabetic ketoacidosis—a life-threatening risk—by warning against rising ketones.
The World's First Dual-Sensor Technology
Developed by Abbott, the Libre Duo 10 Day system holds the distinction of being the world's first dual-sensor wearable biotechnological device capable of simultaneous glucose and ketone tracking.
Early Warning Against Ketoacidosis Risk
This innovative system provides users with early warnings by performing background ketone tracking against the risk of diabetic ketoacidosis, a serious emergency that can develop rapidly in diabetes patients.
Approval Process and Standards
Previously granted breakthrough device designation, the product was approved via the FDA's De Novo authorization and meets standards for both continuous glucose monitoring and the new continuous glucose and ketone monitoring.
Indication and Ecosystem Integration
Designed for diabetes patients aged two and older, the device offers up to ten days of use and works in full integration with the company's latest-generation digital health applications.