FDA okays Viz.ai's algorithm to detect hypertrophic cardiomyopathy

Viz.ai announced Tuesday that its hypertrophic cardiomyopathy (HCM) artificial intelligence (AI) detection algorithm has received FDA De Novo approval, creating a new regulatory category for cardiovascular machine learning-based notification software. The deployment of the Viz HCM module is supported through a multi-year agreement with Bristol Myers Squibb that was announced in March. CEO Chris Mansi said "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."

The module uses AI to allow more patients with suspected HCM to be identified earlier, and then triaged for diagnosis and further evaluation. The technology automatically reviews routine electrocardiograms (ECGs) from across a health system to detect suspected cases, notifying the appropriate cardiologists and care team using the Viz mobile application. Clinicians can assess the patient's ECG and coordinate follow-up with an echocardiogram for diagnosis. They can also use the company's Viz Echo Viewer to review images and access echocardiogram reports.

The company said the module is one of 12 of its FDA-cleared AI algorithms featured on the Viz.ai platform. According to Viz.ai, the platform has been shown to boost access to treatments and improve patient outcomes across over 1400 hospitals in the US and Europe.

Earlier this year, the company launched its AI-powered Viz Vascular Suite and received FDA 510(k) clearance for its algorithm to detect suspected abdominal aortic aneurysms. Viz.ai raised $100 million in Series D financing in 2022, pushing its valuation to $1.2 billion.

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