Regulatory

Anumana’s Low Ejection Fraction ECG-AI Tech Gains CMS Reimbursement

Company’s ECG-AI algorithm enables earlier heart failure detection.

By: Michael Barbella

Managing Editor

The Centers for Medicare & Medicaid Services (CMS) has included Anumana’s low ejection fraction (LEF) ECG-AI technology in the 2025 Hospital Outpatient Prospective Payment System (OPPS) final rule under assignment APC 5734. The approval allows outpatient settings to be reimbursed for Anumana’s ECG-AI service to help identify LEF in adults at risk for heart failure, aiding early cardiac dysfunction detection.

“The new CMS reimbursement ruling reflects our efforts to bring our ECG-AI technology to broader patient populations and recognizes our ongoing leadership in AI-enabled cardiovascular care,” Anumana CEO Maulik Nanavaty stated. “This milestone will help to reduce financial barriers to adopting ECG-AI, facilitating a smooth path for its integration into routine care and ultimately improving patient outcomes in cardiovascular disease management.”

Anumana’s ECG-AI technology, which received Category III CPT codes (0764T and 0765T) in 2023, harnesses advanced AI technology to transform standard ECG data into a powerful diagnostic tool for cardiovascular health. By detecting subtle, clinically significant patterns in ECGs that may indicate underlying conditions, ECG-AI aims to assist healthcare providers in making earlier and more accurate diagnoses, leading to improved patient outcomes.

Anumana is an artificial intelligence-driven health technology company leveraging cutting-edge AI translational science to unlock the heart’s electrical language. The company was founded by nference in collaboration with Mayo Clinic to leverage the clinical and technical expertise of both organizations to develop ECG-AI technology into a clinically meaningful, medical-grade, and easy-to-use tool for clinicians to advance patient care. Anumana’s software-as-a-medical device (SaMD) ECG-AITM solutions aim to detect diseases earlier using standard-of-care ECG readings, enabling clinicians to enhance and improve care with real-time AI insights.

Anumana has received U.S. Food and Drug Administration Breakthrough Device Designation for four of its ECG-AI powered algorithms, including those for low ejection fraction, pulmonary hypertension, cardiac amyloidosis, and hyperkalemia. Its lead algorithm, ECG-AI LEF, is now available in the United States and currently under review in Europe.

Keep Up With Our Content. Subscribe To Medical Product Outsourcing Newsletters