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FDA Grants Anumana's Cardiac Amyloidosis Algorithm Breakthrough Device Designation

Thursday, June 22, 2023

Anumana, Inc., a prominent AI-driven health technology company, has achieved a significant milestone with its ECG-AI algorithm for cardiac amyloidosis. The company has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA). This designation aims to expedite the availability of the algorithm, designed to aid in the early identification of cardiac amyloidosis, a rare and potentially life-threatening cause of heart failure that often goes undiagnosed.

The breakthrough device designation comes as part of Anumana's collaboration with Pfizer, with whom they have a multi-year research agreement to develop ECG-AI solutions for early detection of cardiac amyloidosis. This regulatory milestone represents a crucial step in their partnership, allowing for an accelerated regulatory review process. Anumana plans to conduct a retrospective clinical validation trial and pursue De Novo classification for the algorithm as Software as a Medical Device (SaMD). Their ultimate goal is to obtain regulatory approval for the algorithm's use in detecting cardiac amyloidosis in the United States, Europe, and Japan.

Cardiac amyloidosis is a challenging condition to diagnose early due to its rarity and nonspecific symptoms. Timely identification is crucial for implementing interventions that can improve patient outcomes. Standard ECGs, often interpreted by humans, may miss subtle combinations of features indicative of cardiac amyloidosis. Anumana's ECG-AI algorithm, developed in collaboration with Mayo Clinic, aims to address this diagnostic challenge by utilizing breakthrough technology to enable earlier detection of the disease.

Anumana intends to integrate the algorithm into existing clinical workflows as a Software as a Medical Device (SaMD). The recognition of the algorithm's potential through the FDA Breakthrough Device Designation emphasizes its importance in the early detection of cardiac amyloidosis. Anumana has also received Breakthrough Device Designations from the FDA for algorithms targeting the early identification of low ejection fraction, pulmonary hypertension, and hyperkalemia. The breakthrough designation for the Cardiac Amyloidosis ECG-AI Algorithm further highlights its significance in detecting this disease at an early stage.



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