Israeli firm Donisi Health has received US FDA clearance for its contact-free multiparameter measurement system that can detect workings of internal organs through clothing.

“I’m really proud of our team; we developed a medical device that can change the lives of millions of people,” said Donisi CEO Yair Brosh. “Our novel technology is now recognised and cleared by FDA which is a great accomplishment.”

Backed by 26 granted patents, the system applies a combination of proprietary optics, algorithms and artificial intelligence to detect remotely and analyse surface-level micro-vibrations caused by the workings of internal organs such as heart and lungs.

Clinical results demonstrate the technology maintains medical grade accuracy for people with different medical and physical conditions without needing to remove clothing or connect the patient to wires or patches.

The company is still developing the system 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 pre-submission 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 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.”

The technology detects a wide array of physiological and stress indicators including those key for detecting heart failure exacerbations. Through an AI-driven alert system, users and their support team are provided easy to understand notifications.