Developed in collaboration with Mayo Clinic, with support from Pfizer, this ECG-AI algorithm aims to aid physicians in earlier identification of cardiac amyloidosis
CAMBRIDGE, Mass., June 21, 2023 – Anumana, Inc., a leading AI-driven health technology company, has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its ECG-AI algorithm designed to aid the early identification of cardiac amyloidosis, a life-threatening, rare, underdiagnosed cause of heart failure. This 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 Breakthrough Device Designation recognizes the significant potential of this algorithm, and the designation is a key regulatory milestone under the agreement, providing an expedited pathway for regulatory review.1 Anumana 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 the U.S., Europe, and Japan.
Cardiac amyloidosis is an underdiagnosed disease that often leads to heart failure.2 Early diagnosis is crucial to enable timely interventions that can improve outcomes.3 However, diagnosing this condition early can be challenging because of the rarity of the disease, which often presents with nonspecific signs and symptoms.4 While a standard ECG is obtained during the evaluation of these nonspecific symptoms, human interpretation of the ECG often misses subtle combinations of features that may indicate cardiac amyloidosis.5,6