Viz.ai’s Hypertrophic Cardiomyopathy AI Algorithm Approved by FDA

August 15, 2023—Viz.ai announced it has received FDA de novo approval by for the company’s hypertrophic cardiomyopathy (HCM) artificial intelligence (AI) detection algorithm, the Viz HCM module, creating a new regulatory category for cardiovascular machine learning-based notification software.

The deployment of the algorithm is financially supported by a multiyear agreement with Bristol Myers Squibb announced in March 2023, advised the company.

According to the company, with use of the Viz HCM module—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.

Viz.ai stated in the press release that the Viz HCM module automatically reviews routine electrocardiograms (ECGs) from across a health system to identify suspected HCM cases and notifies the appropriate cardiologists and care team on the Viz mobile application. Clinicians can then review a patient’s ECG, coordinate follow-up with an echocardiogram for diagnosis, and use the Viz Echo Viewer to review images and access echocardiogram reports.

“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,” commented Matthew Martinez, MD, in Viz.ai’s press release. Dr. Martinez, who is Director of Sports Cardiology and HCM, at Atlantic Health System in Morristown, New Jersey, continued, “The role of AI in cardiology is growing exponentially and adding the HCM module to Viz.ai will help increase awareness and reach for HCM patients.”

The HCM module is one of 12 FDA-cleared AI algorithms on the enterprise-wide Viz.ai Platform, which has been shown to increase access to treatments and improve patient outcomes in hospitals in the United States and Europe, noted the company.