FDA greenlights tabletop heart/lung sensor

A zero-contact health monitor about the size and shape of an external laptop speaker—one sure to fire the imagination of many a sci-fi fan—has won de novo clearance from the FDA.

Tel Aviv-based Donisi says its tabletop system uses optics and algorithms to evaluate fully dressed persons up to 16 feet away for subtle changes in heart and respiratory rates.  

According to the company’s website, the optics piece involves detecting back-reflecting light patterns and nano-vibrations as recorded on a vertical surface illuminated by the device, which might be a wall or the patient’s own chest.

The AI supplies medical-grade remote measurements and personalized analytics, all of which the device sends to a smartphone app or other reception point for the patient and/or provider.

Donisi says it’s working with a cardiovascular research center in Israel on engineering the device to monitor specific heart-lung conditions like pulmonary congestion. It’s also working with the FDA on getting the system cleared for identifying atrial fibrillation and other advanced indications.