Anumana

Anumana is an AI-driven health technology company that develops software-as-a-medical-device (SaMD) solutions to detect hidden diseases using electrocardiogram (ECG) AI algorithms. The company's flagship product, ECG-AI LEF, received FDA 510(k) clearance in October 2023 for detecting low ejection fraction (LEF) in patients at risk of heart failure. This device uses data from routine 12-lead ECGs to screen for LEF in adults. It was developed based on pioneering research from Mayo Clinic using over 100,000 ECG and echocardiogram data pairs from unique patients. In a clinical study of 16,000 racially diverse patients, ECG-AI LEF achieved an 84.5% sensitivity and 83.6% specificity for detecting LEF.

Anumana's technology aims to enhance disease detection at earlier, more treatable stages by identifying subtle signals in ECGs that are imperceptible to humans. The company's pipeline includes additional FDA breakthrough-designated algorithms for detecting pulmonary hypertension, cardiac amyloidosis, and hyperkalemia. These algorithms have been validated in over 75 peer-reviewed publications, including prospective studies published in Nature Medicine and The Lancet.

In 2022, Anumana received approval for two CPT III codes from the American Medical Association, establishing ECG-AI as a new innovative procedure. The company's solutions are designed for real-world physician use, integrating into existing clinical workflows at the point of care.

Anumana was founded in 2021 as a joint venture between nference and the Mayo Clinic to leverage their expertise in developing ECG-AI technology from an investigational resource to a clinical tool for clinicians. The company has established multi-year agreements with pharmaceutical partners, including Novartis and Pfizer, to drive the development and delivery of its AI-powered solutions.