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

Viz.ai 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 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 easily review the patient’s ECG, coordinate follow-up with an echocardiogram for diagnosis, and use the Viz Echo Viewer to review images and access echocardiogram reports.

The HCM module is one of twelve FDA-cleared AI algorithms on the enterprise-wide, clinically validated Viz.ai Platform, which has been shown to increase access to treatments and improve patient outcomes across more than 1,400 hospitals in the US and Europe. With the use of Viz HCM, more patients with suspected HCM can be identified earlier using AI and triaged for diagnosis and further evaluation.

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, MD, director of sports cardiology and HCM, Atlantic Health System.

Hypertrophic cardiomyopathy is a devastating disease that is often undetected until it is too late. The addition of Viz HCM to the Viz.ai Platform aims to improve outcomes for patients with HCM by getting them to the right specialist faster, said Chris Mansi, MD, CEO and co-founder at Viz.ai.