Viz.ai has received a green light from the FDA for its artificial-intelligence-powered software that sifts through electrocardiograms to spot signs of a thickened or enlarged heart muscle.
Known as hypertrophic cardiomyopathy, the rare, hidden condition can make it hard for the left ventricle to pump blood out to the rest of the body.
With few obvious symptoms, it can often go undiagnosed, but it can lead to shortness of breath, chest pain, valve impairment or irregular heart rhythms—and, according to Viz.ai, is one of the leading causes of sudden cardiac death for people under age 35.
The Viz HCM algorithm—which received a de novo clearance from the agency—scans 12-lead hospital ECGs to pick out the subtle signs of thickened cardiac tissue in adult patients, which can cause small changes to the traveling electrical signals that power each heartbeat.
The software is set to be bundled with the former Fierce 15 winner’s Cardio Suite of digital tools. It does not provide a diagnosis of HCM by itself, according to the FDA; the condition is typically identified with an ultrasound exam.
Viz HCM’s development was backed by Bristol Myers Squibb, a drugmaker that has taken a special interest in treating HCM as the most common inherited heart disease.
BMS put down $13 billion in late 2020 to acquire MyoKardia and its mavacamten therapy, which works to inhibit developing cardiac muscle tissue. The first-in-class drug and potential blockbuster was approved by the FDA as Camzyos in April 2022.
Previously, the treatment demonstrated that it could reduce the need for surgical procedures in patients with severe and obstructive cases of HCM.