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."
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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."
What is HFpEF?
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.43
The symptoms, which include shortness of breath, chest discomfort, and debilitating fatigue, can have an enormous impact on a person's quality of life. It is a leading cause of hospitalizations and is often deadly, carrying a five-year survival rate of just 35% to 40%.5
Historically, there has been no effective treatment for HFpEF. However, a new therapy, sodium-glucose cotransporter 2 inhibitors (SGLT2is), which has demonstrated a relative risk reduction in heart failure hospitalizations by 29%,6 has recently been approved for use. It places an even greater emphasis on the need for precise diagnosis of HFpEF.
