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.