Admetsys Corporation, a biomedical technology company specializing in critical care automation, announced that the FDA has designated its automated glucose control and continuous blood diagnostics system a Breakthrough Device.

This designation accelerates the system’s path to market in the United States. The system is designed to fill a key gap in the standard of care. It automatically measures 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, evolving as patient condition does, and delivers precisely optimized treatment of insulin and dextrose using its multiple infusion channels.

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

Metabolic parameters can change rapidly in critical care patients—often in minutes. Capturing and modeling variability accurately in real time is difficult to do by hand, without which therapy is approximate and carries considerable clinical risk, according to Admetsys. These challenges are further compounded by scale of the need: 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 decreases complications and increases survivability.

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

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