FDA Grants Breakthrough Designation to Admetsys’ Automated Glucose and Continuous Blood Diagnostics System


This will allow the product to arrive in hospitals at a faster pace.

The FDA designated Admetsys Corporation’s automated glucose control and continuous blood diagnostics system as a breakthrough device. This allows Admetsys to accelerate the device’s timeline for being brought to market in the US.

Jeff Valk, Ceo of Admetsys, said in a press release, “The core of the system is its patient-adaptive learning algorithm. Machine intelligence using real-time biosensing data directly drives therapeutic actuation. This represents a new generation of device: fully autonomous clinical robotics."

The device is able to measure a patient’s blood for multiple analytes without any blood loss. It then uses this information to create a model of the patient’s metabolism and make recommendations for precise treatment levels of insulin and dextrose.

Valk continued, “The system unlocks a previously unachievable mode of care. It affects this economically, at scale, while preserving focus for clinicians. Precision automation fundamentally changes the equation."

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