US-based AI company Anumana has revealed results from a study of an algorithm based on electrocardiogram (ECG) designed to recognise signs of pulmonary hypertension (PH) to expedite diagnosis.
Published in the European Respiratory Journal study entitled “An electrocardiogram-based AI algorithm for early detection of pulmonary hypertension,” found the company’s algorithm could identify signs of the condition based on routinely collected 12-lead ECG data from 39,823 potential patients.
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The study examined retrospective ECG and either right heart catheterisation or echocardiogram data taken from the patients at the US-based Mayo Clinic, as well as a control group of 219,404 patients. The study results were then revalidated on an additional 6,045 PH-likely patients and 24,256 control patients at the Vanderbilt University Medical Center.
Lead author of the study, Hilary DuBrock, said: “The promising data from our study suggest that an AI algorithm has the potential to non-invasively detect PH at an early stage using standard ECGs. This finding marks a significant step forward in the care and management of PH patients who often have a long diagnostic journey.”
The researchers found that the device could identify PH, achieving an area under the receiver operating characteristic curve (AUC) of 0.92 in the diagnostic test set at the Mayo Clinic.
The device was previously granted breakthrough designation by the US Food and Drug Administration (FDA). It also follows after the company was able to secure 510(k) clearance for its ECG-AI LEF algorithm designed for the detection of low ejection fraction (LEF).
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By GlobalDataMaulik Nanavaty, CEO of Anumana, added: “These new data underscore the potential of AI algorithms to empower clinicians to uncover diseases earlier, improve patient outcomes and bring us one step closer to our mission to transform cardiac care.
“We’re continuing to work closely with our partners to further clinically validate this much-needed algorithm, which can help clinicians worldwide get PH patients into treatment sooner to address symptoms and prolong life.”
Elsewhere in the field of algorithm-based medical devices, US-based cardiac technology company HeartBeam has progressed the development of its HeartBeam AIMIGo device, a credit card-sized platform that remains in constant proximity with the patient, generating comprehensive data for AI applications.
