FDA Clears AI-Powered Algorithm for Earlier Detection of Hypertrophic Cardiomyopathy

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The US Food and Drug Administration (FDA) has authorized marketing for Viz.Ai’s Viz HCM, a standalone electrocardiogram (ECG) artificial intelligence algorithm used to identify and triage patients for further evaluation for the detection of hypertrophic cardiomyopathy (HCM).¹

Granted de novo clearance by the FDA, the analysis software can analyze recordings from compatible 12-lead ECGs, detect signs associated with HCM, and allow the user to view the ECG and software analysis.² The device, however, does not provide a diagnosis of HCM and is not intended for use on patients with implanted pacemakers.

Management of HCM has experienced a revolution in recent years, led by the FDA approval of mavacamten and the development of other cardiac myosin ATPase inhibitions. With the combination of this clearance for a new diagnostic methodology and these evolving therapies, the field may be one step closer to optimal management of the disease.

“I think it’s been amazing for us as physicians and also for our patients who until now did not have any targeted therapies for their disease,” said Anjali Owens, MD, medical director of the Center for Inherited Cardiac Disease at the University of Pennsylvania, in a recent interview on the state of HCM management with HCPLive Cardiology. "I think what we’ve seen over the last 10 years is moving from a description of what the heart looks like, the heart is thick or weak or the ejection fraction is low or high, to really understanding the underlying molecular or genetic underpinnings of disease."

HCM is a rare condition defined by an abnormally thickness of the heart muscles, causing difficulties for the heart to pump blood at a normal rate. Although rare, HCM is the most common genetic heart abnormality, with an estimated 1 in every 500 people having HCM.³ However, a large percentage of patients are undiagnosed, often lacking few visible symptoms, and may have an increased risk of developing atrial fibrillation, mitral valve disease, and heart failure.

The Viz HCM algorithm is intended to automatically review routine ECGs from across a health system, identify suspected HCM, and then notify the appropriate cardiologist. The care provider can then review the ECG in a timely manner and recommend appropriate follow-up diagnostic testing in addition to standard of care measures.

​​Earlier this year, the company announced an agreement with Bristol Myers Squibb, the drug maker behind mavacamten, to increase early detection and management of suspected HCM.⁴ The algorithm is expected to be integrated into the Viz.ai Cardio Suite for hospitals in the US, which may advance cardiac care coordination through a mobile-based electrocardiogram viewer, timely AI-powered alerts, and communication tools available to providers.

More than 1,000 hospitals in the US have already integrated the Viz.AI Intelligent Care Coordination Platform, including the Viz.ai Cardio Suite, and the company plans to launch Viz HCM broadly following this FDA clearance to enable greater management of HCM.

“With an increased understanding of what causes cardiomyopathy, that has led to us now having targeted treatments for each different type of disease: the rarer, the more common, and everything in-between,” Owens told HCPLive. “It’s been really amazing to see and to be able to sit with our patients and say, here is what you have and here’s how we think we can treat it. That’s really been quite rewarding.”

References

1. Commissioner of the. FDA roundup: August 4, 2023. U.S. Food and Drug Administration. August 4, 2023. Accessed August 8, 2023. https://www.fda.gov/news-events/press-announcements/fda-roundup-august-4-2023
2. Device classification under Section 513(F)(2)(de novo). accessdata.fda.gov. August 7, 2023. Accessed August 8, 2023. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN230003.
3. Hypertrophic cardiomyopathy (HCM). www.heart.org. June 26, 2023. Accessed August 8, 2023. https://www.heart.org/en/health-topics/cardiomyopathy/what-is-cardiomyopathy-in-adults/hypertrophic-cardiomyopathy.
4. Viz.ai announces agreement with Bristol Myers Squibb to enable earlier detection and management of suspected hypertrophic cardiomyopathy (HCM). Viz.ai, the Proven AI-Powered Care Coordination Platform. July 27, 2023. Accessed August 8, 2023. https://www.viz.ai/news/agreement-bristol-meyers-squibb-hcm.