Tel Aviv, Israel - 04/02/2021 — The US FDA grants clearance to Donisi Health’s measurement system designed to enable identification of changes in cardiopulmonary health
[TLV, Israel, 2021-04-02] – [ContinUse Biometrics, dba Donisi Health, Donisi]
Donisi, a digital health company applying proprietary optics, algorithms, and artificial intelligence to enable detection of changes in health, announced today that the U.S. Food and Drug Administration (FDA) has cleared their revolutionary contact-free multiparameter measurement system for heart rate and respiratory rate measurement via the FDA’s De Novo pathway.
The FDA De Novo approach is a specific clearance process for novel medical devices for which there is no previously established or cleared predicate device or technology. In other words, it is a method to assess novel medical technologies.
Backed by 26 granted patents, the system works by remotely detecting surface-level micro-vibrations caused by the workings of internal organs such as the 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 to measure and detect additional cardiopulmonary parameters and biomarkers, running clinical trials with 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.
For more information or to request an interview, please reach out to Donisi Health (firstname.lastname@example.org).
Media Contacts:Company Name: Donisi Health