Viz.ai announced today that the FDA granted de novo approval to its Viz HCM module for detecting hypertrophic cardiomyopathy.
San Francisco-based Viz.ai says this creates a new regulatory category for cardiovascular machine learning-based notification software. The company supports its algorithm’s deployment through a multi-year agreement with Bristol Myers Squibb. They struck that partnership deal in March of this year.
With Viz HCM — integrated into the Viz.ai platform — providers can identify more patients with suspected HCM earlier using AI. They can then receive triage and diagnosis for further evaluation.
The Viz HCM module automatically reviews routine electrocardiograms (ECGs) from across a health system. It identifies 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 and coordinate follow-up for diagnosis. They can then use the Viz Echo Viewer to review images and access echocardiogram reports.
“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 Dr. Chris Mansi, CEO and co-founder of 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.”