iz.ai, the leader in AI-powered disease detection and intelligent care coordination, today announced it has received a De Novo approval by the U.S. Food and Drug Administration (FDA) for its Viz HCM module, a hypertrophic cardiomyopathy (HCM) artificial intelligence (AI) detection algorithm, creating a new regulatory category for cardiovascular machine learning-based notification software.
The deployment of the algorithm is financially supported by a multi-year agreement with Bristol Myers Squibb (NYSE: BMY) announced in March. With the use of Viz HCM, which is integrated into the Viz.ai Platform, more patients with suspected HCM can be identified earlier using AI and triaged for diagnosis and further evaluation.