FDA Approves Ultromics’ AI Heart Failure Detection Platform

The FDA has given the green light to a new AI-based platform for the detection of heart failure from Ultromics, an offshoot of the University of Oxford. EchoGo Heart Failure, which can leverage advanced AI to precisely detect heart failure with preserved ejection fraction (HFpEF), a multi-organ, systemic syndrome that involves multiple cardiac and extracardiac pathophysiologic abnormalities, was developed in tandem with Mayo Clinic, which worked closely with Ultromics’ echocardiology and AI experts.

The clearance follows a proposal from the company to address this notable unmet medical need with help from the Foundation for the National Institutes of Health (FNIH) Accelerating Medicines Partnership Heart Failure (AMP HF) program. The $37 million, long-term multi-stakeholder partnership, managed by the FNIH, will see the National Institutes of Health (NIH), the National Heart Lung and Blood Institute (NHLBI), and the FDA collaborate for the next five years. Those lesser contributors, The American Society of Echocardiography, the American Heart Association (AHA), and various other industry members are also listed in the deal.

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“We are delighted that the FDA has recognized EchoGo Heart Failure as a breakthrough device and has cleared the technology to provide reliable detection of HFpEF,” said Dr. Ross Upton, Founder and Chief Executive Officer of Ultromics. “The technology improves the accuracy of HFpEF detection, enabling more patients to receive treatment, which will reduce the significant burden on patients and healthcare systems alike.”

EchoGo Heart Failure demonstrated an impressive 90% accuracy in detecting HFpEF in the validation dataset, also reaching 87.8% and 83% sensitivity and specificity, respectively, in the independent testing dataset.