FDA Clears Anumana’s ECG-AI Algorithm for Cardiac Amyloidosis

Cardiovascular artificial intelligence (AI) company Anumana has received U.S. Food and Drug Administration (FDA) clearance for its ECG-AI algorithm for cardiac amyloidosis (CA).

According to the company, ECG-AI is the first and only device cleared for this indication using standard 12-lead electrocardiograms (ECGs). The AI-enabled software-as-a-medical-device (SaMD) was previously granted FDA breakthrough status and was chosen among the first 15 devices in the agency’s Total Product Life Cycle Advisory Program pilot.

Designed to help identify patients at risk for CA at the point of care, the algorithm aims to capture the subtle combinations of features indicating CA that human interpretation often misses.

“Cardiac amyloidosis can be challenging to detect early, especially when its signs overlap with more common heart conditions,” said Martha Grogan, MD, 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 ECG-AI CA model was first developed at Mayo Clinic and validated in a large, independent, multi-center study of 25,525 patients in four U.S. health systems. It detected CA with 78.9% sensitivity and 91.2% specificity in adult patients presenting with signs, symptoms, or comorbidities of CA.

Anumana’s algorithm analyzes ECG waveforms to spot patterns related to CA that aren’t often visible to the human eye. By using ECGs already gathered in clinical practice, the company’s algorithms integrate into existing workflows without needing additional testing.

“Each of our FDA-cleared algorithms addresses a specific and frequently missed cardiovascular condition, and cardiac amyloidosis represents an important addition to that portfolio,” said Maulik Nanavaty, CEO of Anumana. “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.”