AI model for HCM, the first of its kind, gains FDA approval

Viz.ai has received a de novo approval from the U.S. Food and Drug Administration (FDA) for its new artificial intelligence (AI) algorithm designed to identify signs of hypertrophic cardiomyopathy (HCM) in routine electrocardiograms (ECGs).

Viz HCM, the first AI model specifically crafted with detecting HCM in mind, automatically reviews ECGs as they are performed, alerting cardiologists and other members of the heart team so they can personally review the imaging results and proceed as necessary.

“Hypertrophic cardiomyopathy is a devastating disease that is often undetected until it is too late,” Chris Mansi, MD, CEO and co-founder at Viz.ai, said in a prepared statement. “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. 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.”

One of the key issues surrounding HCM care is the fact that the disease can be challenging to diagnose. According to Matthew Martinez, MD, a cardiologist familiar with Viz HCM, adding AI tools to the arsenals of cardiologists could make a significant difference going forward.