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 U.S. Food and Drug Administration (FDA) clearance.
HFpEF is a type of heart failure often associated with co-morbidities and tends to be caused by increased pressure within the chambers of the heart. The ejection fraction, or the volume of blood ejected from the left ventricle at each heartbeat, however, remains in normal ranges. This makes it exceedingly difficult to detect using traditional diagnostics, which can miss up to 75% of cases.2,1
The solution was developed by echocardiography and AI experts from Ultromics, a spin-out of the University of Oxford, in collaboration with Mayo Clinic. The device uses AI to accurately detect HFpEF from a single echocardiogram image, which accounts for 50% of the 64 million cases of heart failure worldwide and has overtaken heart failure with reduced ejection fraction (HFrEF) as the most prevalent form of the deadly disease.1
This development marks a leap forward from traditional diagnostic algorithms for HFpEF, a heterogeneous syndrome that can be challenging to identify, and is missed in up to 75% of cases.2 Current approaches include the time-consuming diastolic function assessment, and require a highly specialized, increasingly rare skillset, and often invasive testing. To counter this, EchoGo Heart Failure has a vital role to play in the future HFpEF landscape.
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 SGLT2is, 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 giant leap forward in addressing the biggest unmet need in cardiovascular medicine.
“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,” says Ross Upton, PhD, CEO and founder of Ultromics. “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.”
 Savarese, G., & Lund, L. H. (2017). Global public health burden of heart failure. Cardiac failure review, 3(1), 7.
 Kapłon‐Cieślicka, A., Laroche, C., et al. Heart Failure Association (HFA) of the European Society of Cardiology (ESC) and the ESC Heart Failure Long‐Term Registry Investigators. (2020). Is heart failure misdiagnosed in hospitalized patients with preserved ejection fraction? From the European Society of Cardiology‐Heart Failure Association EURObservational Research Programme Heart Failure Long‐Term Registry. ESC heart failure, 7(5), 2098-2112.
Featured image: The 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. Photo: Ultromics