FDA clears new AI model for pulmonary hypertension
Anumana, a Massachusetts-based artificial intelligence (AI) company co-founded by nference and Mayo Clinic, has secured U.S. Food and Drug Administration (FDA) clearance for its advanced pulmonary hypertension (PH) algorithm. The algorithm, which previously received the FDA’s breakthrough device designation, was designed to detect signs of PH in standard 12-lead electrocardiograms (ECGs).
PH is a life-threatening condition that can be difficult for care teams to diagnose. It directly impacts the arteries in a patient’s lungs as well as the right side of their heart. While there is no cure, treatments are available once a diagnosis is confirmed.
Anumana’s newly cleared AI model was built with data from more than 250,000 de-identified Mayo Clinic patients. It runs entirely within the care team’s own hospital or health system environment.
According to Anumana, the algorithm was linked to a sensitivity of 73% and specificity of 74.4% in adult patients presenting with dyspnea. A separate study found that it was able to identify more than 85% of patients presenting with pulmonary arterial hypertension as well as 78% of patients presenting with chronic thromboembolic pulmonary hypertension.
“PH is often difficult to recognize until it has progressed significantly, leaving patients and physicians at a disadvantage,” Paul Friedman, MD, chair of the department of cardiovascular medicine at Mayo Clinic and a member of the Anumana advisory board, said in a statement. “FDA clearance of Anumana’s PH algorithm provides clinicians with a practical solution to identify PH earlier and determine appropriate next steps in care, expanding the clinical utility of routine ECGs.”
“The FDA clearance of our PH algorithm is the result of rigorous clinical development and regulatory work, and it marks a meaningful step toward expanding access to AI-enabled insights at the point of care,” added Simos Kedikoglou, president & COO of Anumana. “As the first PH algorithm cleared for use with standard 12-lead ECGs, it is broadly accessible across care settings, integrates directly into existing clinical workflows, and supports clinical decision-making in real time, with the potential to help identify patients earlier in their disease course. This milestone reflects Anumana’s broader vision to expand the role of ECGs in identifying cardiovascular risk earlier and at scale.”
Back in October 2023, Anumana secured FDA clearance for an algorithm that detects signs of low ejection fraction in 12-lead ECGs.
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.