Sam Brusco, Associate Editor12.06.22
Ultromics has earned U.S. Food and Drug Administration (FDA) clearance for EchoGo Heart Failure, an artificial intelligence (AI) solution for echocardiography that could revolutionize diagnosis of heart failure with preserved ejection fraction (HFpEF).
Ultromics is a spin-out from University of Oxford in collaboration with Mayo Clinic. The device used AI to spot HFpEF from one echocardiogram image, accounting for half of the 64 million cases of heart failure worldwide.
HFpEF is a heterogeneous syndrome that can be tough to identify. Current approaches to spot it include time-consuming and often inconclusive assessment of diastolic function and need a highly specialized, increasingly rare skillset, and often invasive testing.
The FDA clearance comes weeks after Ultromics joined the FNIH (Foundation for the National Institutes of Health) Accelerating Medicines Partnership Heart Failure (AMP HF) program. The $37 million, five-year multi-stakeholder collaboration, managed by FNIH, is a collaboration between the National Institutes of Health (NIH) and the National Heart Lung and Blood Institute (NHLBI), the FDA, the American Heart Association (AHA), the American Society of Echocardiography, and industry members.
Dr Ross Upton, CEO and founder of Ultromics, told the press, "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. 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 is in the 7% of devices that have gone on to gain full marketing authorization after being awarded FDA breakthrough status.
Ultromics is a spin-out from University of Oxford in collaboration with Mayo Clinic. The device used AI to spot HFpEF from one echocardiogram image, accounting for half of the 64 million cases of heart failure worldwide.
HFpEF is a heterogeneous syndrome that can be tough to identify. Current approaches to spot it include time-consuming and often inconclusive assessment of diastolic function and need a highly specialized, increasingly rare skillset, and often invasive testing.
The FDA clearance comes weeks after Ultromics joined the FNIH (Foundation for the National Institutes of Health) Accelerating Medicines Partnership Heart Failure (AMP HF) program. The $37 million, five-year multi-stakeholder collaboration, managed by FNIH, is a collaboration between the National Institutes of Health (NIH) and the National Heart Lung and Blood Institute (NHLBI), the FDA, the American Heart Association (AHA), the American Society of Echocardiography, and industry members.
Dr Ross Upton, CEO and founder of Ultromics, told the press, "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. 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 is in the 7% of devices that have gone on to gain full marketing authorization after being awarded FDA breakthrough status.