Donisi scores FDA clearance for contactless AI system that spots changes in heart, breathing patterns

It goes against all medical knowledge and basic common sense to say vital signs are only skin deep, but that’s exactly the case for a newly FDA-cleared platform that can detect shifts in cardiac and pulmonary performance from afar.

The FDA Thursday granted a de novo clearance to a sensor system from Donisi Health for measuring a person's pulse and respiratory rate. The Israel-based company's technology uses optical sensors and infrared light to capture micro-movements on the skin without requiring any wires or patches; the small devices can measure vital signs through clothing and from up to 16 feet away.

Algorithms and artificial intelligence then analyze those measurements for any abnormalities or changes in cardiopulmonary patterns.

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Donisi’s system has so far been integrated into two tabletop monitors—with a third, wall-mounted model in development—that can transmit the collected data to a telehealth or senior care provider via mobile app and online platform.

The company, founded as ContinUse Biometrics in 2015, has also submitted its atrial fibrillation detection technology for review and is in the process of developing more applications for the platform, including for spotting pulmonary congestion, heart rate variability and respiratory rhythms.

"This is an exciting step in our path to fulfilling our mission of changing lives without changing lifestyles," Sagi Polani, Ph.D., Donisi's chief medical officer, said in a statement. "As we move forward, I can envision how our medical device will bridge the continuum of care from hospital to home, impacting lives and health.”

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This FDA clearance comes only a few days after the agency OK’d a similar contact-free vital sign monitor from U.K.-based Oxehealth, which uses an overhead camera to take an individual’s pulse and count their breaths. Oxehealth’s system is marketed toward nursing homes and long-term care facilities, with the technology also able to detect falls, other injuries and sleep quality.