FDA clears new AI model for detecting signs of cardiac amyloidosis
Anumana, a Massachusetts-based artificial intelligence (AI) company co-founded by nference and Mayo Clinic, has received U.S. Food and Drug Administration (FDA) clearance for a new algorithm designed to detect signs of cardiac amyloidosis (CA). This represents Anumana’s second FDA clearance in just two weeks, highlighting the company’s growing impact in the world of cardiovascular care.
CA is a life-threatening condition that often leads to heart failure complications, but it remains critically underdiagnosed. Anumana sees this clearance as a way to help care teams identify CA early so patients can receive timely treatment.
The newly cleared algorithm, which previously received the FDA’s breakthrough device designation, was designed to evaluate standard 12-lead electrocardiograms (ECGs) and flag patients at increased risk of CA.
“Each of our FDA-cleared algorithms addresses a specific and frequently missed cardiovascular condition, and cardiac amyloidosis represents an important addition to that portfolio,” Maulik Nanavaty, CEO of Anumana, said in a prepared statement. “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 FDA’s decision was largely based on data from a large multi-center study of more than 25,000 patients across four U.S. health systems. The ECG-AI algorithm showed a 78.9% sensitivity and 91.2% specificity when it came to detecting signs of CA in adults.
“Cardiac amyloidosis can be challenging to detect early, especially when its signs overlap with more common heart conditions,” said Martha Grogan, MD, a consultant in cardiovascular medicine with 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.”
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.