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."
FDA issues de novo clearance for SonoMotion’s Stone Clear device, for kidney stone treatment
Stone Clear is the first and only device cleared by the FDA that uses external ultrasound pulses to facilitate passage of post-lithotripsy kidney stone fragments without surgery.
