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# Breakthrough Status on Auto Glucose Device
- URL: https://www.fdaweb.com/breakthrough-status-on-auto-glucose-device/
- Published: 2023-09-06T12:00:00.000Z
- Updated: 2026-09-14T18:54:45.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5155260

FDA has granted Admetsys a breakthrough device designation for its automated glucose control and continuous blood diagnostics system. The device is intended to automatically measure multiple blood analytes, including glucose, in real-time with no patient blood loss. “From this, it creates an adaptive, computational model of each patient’s metabolism…, and delivers precisely optimized treatment of insulin and dextrose using its multiple infusion channels, the company says.

The device’s primary feature is its “patient-adaptive learning algorithm,” according to the company. “Machine intelligence using real-time biosensing data directly drives therapeutic actuation. This represents a new generation of device: fully autonomous clinical robotics.”

Admetsys notes that about 80% of critical care patients experience metabolic instability and risk from glucose dysregulation. “Correctly controlling glucose speeds healing at the tissue level, which is particularly decisive for recovery in cardiovascular and surgical patients,” it says. “It decreases complications and increases survivability.”