FDA clears AI algorithm to detect early PH signs from standard test
Anumana’s tool designed to integrate with standard 12-lead ECGs
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Anumana‘s AI-enabled algorithm for the early detection of pulmonary hypertension (PH) has been cleared for use by the U.S. Food and Drug Administration (FDA).
“The FDA clearance of our Pulmonary Hypertension 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,” Simos Kedikoglou, president and chief operating officer of Anumana, said in a company press release.
Anumana’s algorithm is designed to be used in combination with a standard 12-lead electrocardiogram (ECG), a common and noninvasive heart test that uses electrodes placed on the skin to measure the heart’s electrical activity. By analyzing ECG data patterns, the algorithm aims to help clinicians determine whether or not patients are likely to have PH. It is notably the first FDA-cleared algorithm designed to help detect PH with a standard ECG setup.
“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,” Kedikoglou said.
The new algorithm was developed using 250,000 de-identified patient records from Mayo Clinic, which co-founded Anumana and has a financial interest in the company. Researchers used AI tools to identify patterns associated with PH in this massive dataset, allowing them to generate an algorithm designed to look for these patterns.
Accuracy tops 70% in study
Anumana said an independent, real-world study of more than 21,000 people in the U.S. showed that, among adults with dyspnea (shortness of breath), the algorithm was more than 70% accurate at identifying those who had PH.
PH is characterized by elevated pressure in the vessels that carry blood from the heart to the lungs, which strains the heart. Often, patients with PH don’t get diagnosed and start receiving appropriate treatment until the disease is relatively advanced. By facilitating earlier detection, Anumana’s algorithm aims to enable patients to receive prompt treatment and achieve better long-term outcomes.
“Pulmonary hypertension is often difficult to recognize until it has progressed significantly, leaving patients and physicians at a disadvantage,” said Paul Friedman, MD, chair of the department of cardiovascular medicine at Mayo Clinic and a member of the Anumana advisory board. “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.”
