CAMBRIDGE, Mass. — Anumana, Inc. has received U.S. Food and Drug Administration clearance for its ECG-AI algorithm designed to detect cardiac amyloidosis, marking the first and only cleared tool for this condition using a standard 12-lead electrocardiogram.
The software, an AI-enabled software-as-a-medical-device, is intended to help clinicians identify patients at risk for cardiac amyloidosis at the point of care using ECG data already collected during routine evaluations.
Cardiac amyloidosis is a serious and often underdiagnosed condition caused by abnormal protein deposits in the heart, which can lead to heart failure if not identified early. Because symptoms frequently overlap with more common cardiac conditions, diagnosis is often delayed. While ECGs are widely used, subtle indicators of the disease can be missed through traditional interpretation.
“Cardiac amyloidosis can be challenging to detect early, especially when its signs overlap with more common heart conditions,” said Martha Grogan, M.D., consultant in Cardiovascular Medicine at Mayo Clinic and co-principal investigator of the clinical study. “A tool that helps clinicians recognize suspicion of amyloidosis from a routine ECG could support earlier diagnosis and more timely next steps in care.”
The algorithm was initially developed at Mayo Clinic and later validated in a multi-center study involving 25,525 patients across four U.S. health systems. In that study, the tool demonstrated 78.9 percent sensitivity and 91.2 percent specificity in detecting cardiac amyloidosis among adults presenting with related signs, symptoms, or comorbidities.
“What makes this work especially meaningful is the rigor of the validation,” said Angela Dispenzieri, M.D., hematologist at Mayo Clinic and co-principal investigator of the clinical study. “This ECG-AI algorithm was validated in a large multicenter study that included both ATTR and AL cardiac amyloidosis at major referral centers with deep expertise in amyloidosis diagnosis, supporting its potential to help identify patients earlier.”
Anumana Chief Executive Officer Maulik Nanavaty said the clearance expands the company’s growing portfolio of AI-driven cardiovascular tools.
“Each of our FDA-cleared algorithms addresses a specific and frequently missed cardiovascular condition, and cardiac amyloidosis represents an important addition to that portfolio,” Nanavaty said. “The more conditions we can identify from a single ECG, the more valuable the test becomes in clinical practice. That’s what Anumana is working toward with each new clearance as we continue to advance our rigorous clinical evidence approach.”
The algorithm analyzes ECG waveforms to detect patterns associated with cardiac amyloidosis that may not be visible to the human eye. Because it leverages existing ECG data, the technology can be integrated into clinical workflows without requiring additional testing.
The clearance builds on Anumana’s existing lineup of FDA-cleared ECG-AI tools, which include algorithms for detecting low ejection fraction and pulmonary hypertension. The company said it is continuing to develop additional algorithms to expand its cardiovascular diagnostics portfolio.
