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FDA Clears AI Model to Screen for Cardiac Amyloidosis

Following global validation the model has FDA clearance with U.S. hospital deployments under way to streamline noninvasive screening pathways.

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Overview

  • Developed by Mayo Clinic and Ultromics the algorithm analyzes a single apical four-chamber echocardiogram clip to flag amyloid protein buildup in the heart.
  • In a multiethnic study published in the European Heart Journal the tool demonstrated 85% sensitivity and 93% specificity across major amyloidosis subtypes.
  • It outperformed standard clinical scoring and echo-based methods to inform decisions on confirmatory imaging or biopsy.
  • Clinicians at several U.S. centers have integrated the FDA-cleared system into routine echocardiography workflows for faster patient referral.
  • Early identification enables prompt initiation of new therapies that can slow or halt disease progression when started in initial stages.