FDA clears AI-guided device to diagnose HFpEF from a single echocardiogram
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Ultromics announced its artificial intelligence-guided device for the diagnosis of HF with preserved ejection fraction via echocardiogram has received full marketing authorization from the FDA.
The device (EchoGo Heart Failure) was developed by Ultromics, a spin-out of the University of Oxford, in collaboration with Mayo Clinic, according to a press release issued by the company.
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The device uses AI to detect HFpEF from a single echocardiogram image, a diagnosis that is missed in up to 75% of cases, according to the release.
"It has been a pleasure to collaborate with the team at Ultromics to develop and test EchoGo Heart Failure,” Patricia A. Pellikka, MD, vice chair of the department of cardiovascular medicine at Mayo Clinic, said in the release. “This novel solution applies AI to cardiovascular imaging to greatly simplify identification of patients with HFpEF, a diagnosis that can be challenging to make, and allow more expeditious treatment. HFpEF currently is associated with high rates of hospitalization and mortality. By facilitating early diagnosis and treatment, we can improve the lives of many."
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