Donisi Health, a Tel Aviv-based maker of contactless health monitoring products, recently announced it has received FDA De Novo clearance for its Gili Pro BioSensor system.
The Gili Pro uses a combination of optical sensors and proprietary artificial intelligence algorithms to remotely monitor surface-level micro-vibrations associated with the workings of internal organs.
As indicated by the FDA, the system can estimate pulse rate, heart rate, respiratory rate and/or breathing rates.
"Having been with the company since its first year, I am awed and inspired to be part of the team that is bringing this amazing futuristic technology to life," Dr. Sagi Polani, the chief medical officer at Donisi, said in a statement.
"This is an exciting step in our path to fulfilling our mission of changing lives without changing lifestyles. 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.”
Donisi is working to expand the clinical scope of the Gili Pro and says it has already undergone the FDA Pre Submission process for the identification of atrial fibrillation.
Throughout clinical testing, the Gili Pro maintained medical-grade accuracy across differing body shapes and skin tones, the company said in its announcement. Users can control the sensor and view near real-time measurement results through the connected Donisi mobile application.
WHY THIS MATTERS
Changes in heart and respiratory rates are an important indicator of cardiac and pulmonary functioning that can give patients and physicians the information needed to make critical health decisions, according to a research review in Sensors.
Traditional measurement methods typically involve contact-based sensors, such as pulse oximeters and electrocardiograms.
While technological advances have allowed these sensors to be adapted into some wearable health devices, there are still shortcomings associated with these methods, such as finite battery life, the review said. Contact-based sensors can scar newborn babies, can be difficult to apply on the skin of burn victims and can get in the way of sleeping.
The prospect of remote continuous vital-sign monitoring is especially desirable amid the pandemic, since it allows for data collection from afar. The Gili Pro, for example, can be set up on any tabletop surface to allow for at-home continuous monitoring.
THE LARGER TREND
Last spring, at the head of the pandemic, the FDA expanded the use of vital-sign monitors to allow for increased remote-care capabilities.
A similar contactless vital sign monitoring system by Oxehealth also recently received FDA De Novo clearance. The Oxehealth Vital Signs device differs from the Donisi system because it's a fixed installation for use in single-occupancy rooms, in certain provider settings where professionals periodically check on the patient's safety.
Google threw its hat into the contactless monitoring ring with the launch of its second-generation Nest Hub. The device is equipped with remote sleep-monitoring capabilities that observe the sleeper's movements and respiratory rate from a distance.
Interest in turning smart speakers into contactless vital-sign devices continues to expand outside of Google. Researchers at the University of Washington study how to enable Amazon Echo, Google Nest and other connected speakers to monitor heart rhythms. Their proof-of-concept design could measure heart rate and inter-beat intervals for both regular and irregular rhythms as well as an electrocardiogram.
ON THE RECORD
"I'm really proud of our team; we developed a medical device that can change the lives of millions of people,” Donisi CEO Yair Brosh said in a statement. “Our novel technology is now recognized and cleared by FDA, which is a great accomplishment."