ECG-AI algorithm for early identification of amyloidosis gains US FDA breakthrough designation

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Anumana has received breakthrough device designation from the US Food and Drug Administration (FDA) for its electrocardiogram (ECG) artificial intelligence (AI) algorithm designed to aid the early identification of cardiac amyloidosis.

The breakthrough device designation was granted to provide patients and healthcare providers timely access to the algorithm, subject to approval.

Anumana previously announced a multi-year research agreement with Pfizer to develop ECG-AI solutions to aid in early identification of cardiac amyloidosis. The company plans to conduct a retrospective clinical validation trial and pursue De Novo classification for the algorithm as Software as a Medical Device (SaMD) and aims to gain regulatory approval for the algorithm for the detection of cardiac amyloidosis in USA, Europe, and Japan.

Cardiac amyloidosis is an underdiagnosed disease that often leads to heart failure. Diagnosing this condition early can be challenging because of the rarity of the disease, which often presents with non-specific signs and symptoms.

While a standard ECG is obtained during the evaluation of these non-specific symptoms, human interpretation of the ECG often misses subtle combinations of features that may indicate cardiac amyloidosis.

Developed in collaboration with Mayo Clinic, Anumana’s ECG-AI algorithm aims to address this medical need with breakthrough technology that facilitates earlier identification of this underdiagnosed condition. Anumana is currently developing this algorithm as a SaMD, with the goal of integrating this solution into existing clinical workflows.

“The use of AI algorithms to identify subtle signals in ECGs that are imperceptible to humans stands to transform cardiovascular medicine by allowing us to detect disease early, in more easily treated stages, potentially avoiding serious consequences,” said Paul Friedman (Mayo Clinic, Rochester, USA) and chair of Anumana’s Mayo Clinic board of advisors. “It is encouraging to see an algorithm that can aid in identification of cardiac amyloidosis receive breakthrough device designation, as it recognises the importance of having new tools to detect rare cardiac diseases in ways never before possible.”


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