Viz.ai Nabs De Novo Nod for Hypertrophic Cardiomyopathy AI Algorithm

Viz.ai has earned De Novo approval from the U.S. Food and Drug Administration (FDA) for its Viz HCM module, a hypertrophic cardiomyopathy (HCM) artificial intelligence (AI) detection algorithm. According to the company, this creates a new regulatory category for cardiovascular machine learning-based software.
 
The algorithm’s deployment was financially supported by a multi-year agreement with Bristol Myers Squibb. The company said Viz HCM’s release means 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,” Matthew Martinez, MD, director of sports cardiology and HCM, Atlantic Health System, told the press. “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.”
 
Viz HCM automatically reviews routine ECGs to spot suspected HCM cases, then alerts the patient’s cardiologists and care team on the Viz mobile app. Clinicians can then review the ECG, coordinate followup with an echocardiogram for diagnosis, and use the Viz Echo Viewer to review images and access echocardiogram reports.
 
The HCM module is one of 12 FDA-cleared AI algorithms on the Viz.ai Platform.
 
“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. “We are thrilled with this De Novo approval, which establishes the new FDA category of cardiovascular machine learning-based notification software. The ongoing investment of innovative capabilities on our platform is why it continues to be the first choice of leading healthcare systems. With our AI-powered Viz HCM module, we look forward to realizing its promise in expediting detection and care of patients with this common, inherited heart disease.”