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Viz.ai Gets FDA Nod for Hypertrophic Cardiomyopathy Module


The De Novo approval for Viz HCM, which assesses electrocardiograms with artificial intelligence (AI) to identify possible cases of hypertrophic cardiomyopathy (HCM), is the 12th FDA clearance of algorithms on the Viz.ai Platform.

The Food and Drug Administration (FDA) has granted De Novo approval for Viz HCM, a new artificial intelligence (AI) module that facilitates detection of hypertrophic cardiomyopathy (HCM) through assessment of routine electrocardiograms (ECGs).1

After AI-powered assessment of ECGs, Viz.ai said the Viz HCM module alerts cardiologists and other health-care providers via the Viz mobile app on findings that are suspicious for HCM.

The company noted that the De Novo FDA approval represents the 12th algorithm clearance for its Viz.ai Platform and Viz HCM is the first AI algorithm for HCM to receive De Novo approval. Researchers have estimated that HCM affects one out of 500 people in the United States.2

“Given the high prevalence of patients with suspected HCM who remain undiagnosed, flagging and connecting them quickly to the right providers is critical to improve health outcomes,” said Matthew Martinez, M.D., the director of sports cardiology and HCM with Atlantic Health System in Morristown, N.J. “The role of artificial intelligence in cardiology is growing exponentially and adding the HCM module to Viz.ai will help increase awareness and reach for HCM patients.”


1. Viz.ai. Viz.ai receives first de novo approval by the FDA for hypertrophic cardiomyopathy AI algorithm. Business Wire. Available at: https://www.businesswire.com/news/home/20230815951202/en/Viz.ai-Receives-First-De-Novo-Approval-by-the-FDA-for-Hypertrophic-Cardiomyopathy-AI-Algorithm . Published August 15, 2023. Accessed August 15, 2023.

2. Butzner M, Leslie DL, Cuffee Y, Hollenbeak CS, Sciamanna C, Abraham T. Stable rates of obstructive hypertrophic cardiomyopathy in a contemporary era. Front Cardiovasc Med. 2022 Jan 6;8:765876. doi: 10.3389/fcvm.2021.765876.

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