FDA Bestows Initial De Novo Approval on's AI Algorithm for Hypertrophic Cardiomyopathy

Tuesday, August 15, 2023, a trailblazer in harnessing AI for disease detection and intelligent care coordination, has proudly announced a significant milestone. The U.S. Food and Drug Administration (FDA) has granted De Novo approval for's Viz HCM module, an ingenious artificial intelligence (AI) algorithm engineered to detect hypertrophic cardiomyopathy (HCM). This noteworthy achievement paves the way for a unique regulatory category tailored to machine learning-based notification software within the cardiovascular domain.

The inception and realization of this algorithmic breakthrough have been made possible through a substantial and enduring partnership with Bristol Myers Squibb (NYSE: BMY), as highlighted in their joint March declaration. By seamlessly integrating Viz HCM into the existing Platform, a more proactive approach to identifying potential HCM cases through AI has been established, allowing for swift diagnosis and subsequent evaluation. This holds particular significance due to the sizable number of undiagnosed suspected HCM cases. The timely identification and linkage of such cases with appropriate healthcare providers hold the potential to substantially enhance health outcomes.

The domain of cardiology is witnessing a remarkable surge in the adoption of artificial intelligence. The assimilation of the HCM module into's platform is poised to broaden awareness and accessibility for patients grappling with HCM. Functioning seamlessly, the Viz HCM module scrutinizes routine electrocardiograms (ECGs) across healthcare systems, effectively singling out potential HCM instances. Subsequent notifications are dispatched to pertinent cardiologists and care teams through the Viz mobile application. This streamlines the review of ECGs, expedites arrangements for diagnostic echocardiograms, and facilitates access to echocardiogram images and reports through the Viz Echo Viewer.

Importantly, the HCM module joins the ranks of twelve FDA-cleared AI algorithms integrated into the comprehensive and clinically validated Platform. This platform has consistently demonstrated its ability to extend treatment accessibility and elevate patient outcomes across an extensive network of over 1,400 medical institutions spanning the United States and Europe.

Hypertrophic cardiomyopathy, a profoundly impactful ailment often detected belatedly, stands to gain immensely from the strategic incorporation of Viz HCM into the Platform. This integration holds the promise of expedited referrals to specialists, thereby augmenting patient prognosis and care.'s unwavering commitment to ongoing innovation is underscored by their investment in such groundbreaking capabilities, rendering their platform the preferred choice for distinguished healthcare systems. Powered by AI, the Viz HCM module ushers in a new era of advanced cardiovascular care.



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