Donisi Health Gets FDA’s De Novo Clearance for Its Gili Biosensor System

Tel Aviv, Israel-based Donisi Health has received authorization to market its Gili biosensor system under the FDA’s De Novo pathway.

The device uses an optical sensor and software algorithms to gather and analyze video data and estimate pulse rate, heart rate, respiratory rate and/or breathing rates.

The system is indicated for use “by or under the supervision of healthcare professionals for adult patients in a hospital, outpatient, or other medical care settings, or for clinical research purposes,” the FDA said, adding that it is “not intended to independently direct therapy.”

The agency has identified the new type of device as “hardware and software for optical camera-based measurement of pulse rate, heart rate, breathing rate and/or respiratory rate.”