FDA Grants Donisi De Novo Clearance for Innovative Contact-Free Multiparameter Health Sensing Solution
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.
Clinical results demonstrate Donisi’s technology maintains medical grade accuracy for people with different medical and physical conditions (physique, skin tone, etc.), without needing to remove clothing or connect the patient to wires or patches.
The company continues to develop its system, building ground-breaking solutions to measure and detect additional cardiopulmonary parameters, such as pulmonary congestion, in collaboration with the Cardiovascular Research Center at the Tel Aviv Sourasky Medical Center. Donisi has already undergone the FDA Presubmission process for the identification of atrial fibrillation (AFib) and plans for additional submissions.
“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” said Donisi Chief Medical Officer Dr. Sagi Polani. “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,” he continued.