The U.S. Food and Drug Administration (FDA) has granted Donisi‘s revolutionary contact-free multiparameter measurement system de novo clearance, making Donisi the first to bring this innovative technology to the medical market.
“I’m really proud of our team; we developed a medical device that can change the lives of millions of people. Our novel technology is now recognized and cleared by FDA which is a great accomplishment,” said Donisi CEO, Yair Brosh.
Backed by 26 granted patents, the system applies a combination of proprietary optics, algorithms, and artificial intelligence to remotely detect and analyze surface-level micro-vibrations caused by the workings of internal organs such as heart and lungs.