Anumana, a leading AI-driven health technology company, has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its ECG-AI algorithm designed to aid in the early identification of cardiac amyloidosis. This rare and life-threatening condition is often underdiagnosed and can lead to heart failure. The Breakthrough Device Designation allows for expedited regulatory review and aims to provide timely access to the algorithm for patients and healthcare providers, pending approval.
Anumana has previously collaborated with Pfizer on a multi-year research agreement to develop ECG-AI solutions for the early detection of cardiac amyloidosis. The recognition of the algorithm's potential through the Breakthrough Device Designation is an important milestone under this agreement, opening up a faster pathway for regulatory review. Anumana intends to conduct a retrospective clinical validation trial and pursue De Novo classification for the algorithm as a Software as a Medical Device (SaMD). The company aims to obtain regulatory approval for the algorithm's use in detecting cardiac amyloidosis in the United States, Europe, and Japan.
Cardiac amyloidosis is an often undiagnosed disease that frequently leads to heart failure. Early detection plays a crucial role in enabling timely interventions and improving outcomes. However, the rarity of the disease and its nonspecific signs and symptoms make early diagnosis challenging. Standard ECG evaluations may miss subtle combinations of features indicative of cardiac amyloidosis, highlighting the need for advanced diagnostic tools.
Developed in collaboration with Mayo Clinic, Anumana's ECG-AI algorithm aims to address this diagnostic challenge by leveraging breakthrough technology for the early identification of cardiac amyloidosis. The algorithm is being developed as a Software as a Medical Device (SaMD), with the goal of integrating it into existing clinical workflows.
The use of AI algorithms capable of identifying subtle signals in ECGs that are often undetectable by humans has the potential to transform cardiovascular medicine. Such technology allows for the early detection of diseases in more easily treatable stages, potentially preventing serious consequences. The FDA's recognition of Anumana's Cardiac Amyloidosis ECG-AI Algorithm through the Breakthrough Device Designation underscores the importance of innovative tools for identifying rare cardiac diseases in ways previously not possible.
Anumana, founded in 2021 in collaboration with the Mayo Clinic Platform, is a portfolio company of nference. The company has developed a robust pipeline of FDA-ready ECG-AI algorithms, validated through over 75 peer-reviewed publications. They have received four Breakthrough Device Designations from the FDA, including for algorithms targeting early identification of low ejection fraction, pulmonary hypertension, hyperkalemia, and now, cardiac amyloidosis. The FDA's recognition of the Cardiac Amyloidosis ECG-AI Algorithm highlights its significant potential in enabling early disease detection.
