FDA grants breakthrough designation for new AI model to detect cardiac amyloidosis in ECG results
Anumana, a Massachusetts-based healthcare technology company focused on artificial intelligence (AI), has received a breakthrough device designation from the U.S. Food and Drug Administration (FDA) for a new algorithm designed to identify signs of cardiac amyloidosis in electrocardiograms (ECGs).
Cardiac amyloidosis, a life-threatening heart condition that often leads to heart failure, can be especially difficult to diagnose. Back in December 2022, Anumana announced signing a new multi-year deal with Pfizer to develop a new AI algorithm for detecting cardiac amyloidosis in ECG results. Receiving this breakthrough device designation from the FDA represents a key step forward for that collaboration. The companies are now targeting full regulatory approval for the algorithm in the U.S., Europe and Japan.
Another significant player in the development of this new ECG-AI algorithm was Mayo Clinic in Rochester, Minnesota, which has a longstanding relationship with the team at Anumana.
“The use of AI algorithms to identify subtle signals in ECGs that are imperceptible to humans stands to transform cardiovascular medicine by allowing us to detect disease early, in more easily treated stages, potentially avoiding serious consequences,” Paul Friedman, MD, chair of the department of cardiovascular medicine at Mayo Clinic and chair of Anumana’s Mayo Clinic Board of Advisors, said in a prepared statement. “It is encouraging to see an algorithm that can aid in identification of cardiac amyloidosis receive breakthrough device designation, as it recognizes the importance of having new tools to detect rare cardiac diseases in ways never before possible.”
“The ubiquitous nature of the painless, non-invasive electrophysiology tests gives ECG-AI algorithms the potential to reach a larger number of patients earlier, something clinicians have long hoped for,” added Venky Soundararajan, PhD, co-founder and chief scientific officer of Anumana.
Anumana has now received the FDA’s breakthrough device designation for four algorithms. The previous three algorithms were designed to identify signs of low ejection fraction, pulmonary hypertension and hyperkalemia. Read more about the company’s AI model for pulmonary hypertension here.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.