Ultromics’ EchoGo Heart Failure, an AI solution for echocardiography with the potential to revolutionize the diagnosis of heart failure with preserved ejection fraction (HFpEF), has received US Food and Drug Administration (FDA) clearance.

The solution was developed by echocardiography and AI experts from Ultromics, a spin-out of the UK’s University of Oxford, in collaboration with Mayo Clinic. The device uses AI to accurately detect HFpEF from a single echocardiogram image.

HFpEF is a heterogeneous syndrome that can be challenging to identify. Current approaches include time-consuming and often inconclusive diastolic function assessment, and require a highly specialized, increasingly rare skillset, and often invasive testing.

The FDA clearance comes just weeks after Ultromics demonstrated its commitment to addressing this area of significant unmet medical need by joining 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.

The partnership seeks to develop a deeper understanding of HFpEF and develop more precise strategies and targeted therapies that could improve the lives of millions and improve survival while minimizing exposure to invasive techniques.

There is an urgent need to develop predictive tools to help diagnose HFpEF patients. Patients can now benefit from new therapy drugs, such as SGLT2, which has been shown to significantly reduce both hospitalizations and potentially fatal adverse events. The simultaneous clearances of EchoGo Heart Failure to improve HFpEF detection and SGLT2 to improve treatment represents a leap forward in addressing an unmet need in cardiovascular medicine.

Dr Ross Upton, CEO and Founder of Ultromics, said, “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.

“Although compelling progress has been made in the diagnosis and treatment of many forms of heart disease, heart failure hospitalizations and mortality continue to rise globally. It is now time to make a change. Together with our FNIH AMP HF partners, we aim to redefine the heart failure care pathway and improve world-wide patient outcomes.”

Patricia A. Pellikka, MD, Vice Chair, Department of Cardiovascular Medicine at Mayo Clinic, said, “It has been a pleasure to collaborate with the team at Ultromics to develop and test EchoGo Heart Failure. 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.”

Dr Julie Gerberding, Chief Executive Officer at the FNIH, said, “The Foundation for the National Institutes of Health will harness the valuable perspectives and expertise of a select number of collaborations, including Ultromics, to alleviate this unmet need and pave the way for better classification and more precise treatment strategies.”

[Source(s): Ultromics, PR Newswire]

[PHOTO CAPTION: The first and only AI-enabled HFpEF detection platform for echocardiography, designed to connect to any care setting to support clinicians with HFpEF diagnosis, allowing them to accurately detect HFpEF and send patients onto life-saving therapy. (Image courtesy of Ultromics]