Viz.ai Receives First De Novo Approval by the FDA for Hypertrophic Cardiomyopathy AI Algorithm

Viz.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.

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