AI-powered platform for heart failure detection gains FDA clearance

Michael Walter | December 08, 2022 | Cardiovascular Business | Heart Failure

Tablet projecting metaphorical medical hologram

Ultromics, a U.K.-based healthcare technology company focused on heart failure detection, has received U.S. Food and Drug Administration (FDA) clearance for its EchoGo Heart Failure platform.

EchoGo Heart Failure uses advanced artificial intelligence algorithms to detect signs of heart failure with preserved ejection fraction (HFpEF) in echocardiograms. The platform had previously been awarded the FDA’s breakthrough device designation, a sign that the agency has seen value in the platform from the beginning.

Ultromics worked closely with Mayo Clinic on the design and development of EchoGo Heart Failure. According to data submitted to the FDA, the platform has been linked to an accuracy of 90%, sensitivity of 87.8% and specificity of 83%. It is able to identify if a patient shows any signs of HFpEF by evaluating a single echocardiogram.

“It has been a pleasure to collaborate with the team at Ultromics to develop and test EchoGo Heart Failure,” Patricia A. Pellikka, MD, vice chair of the department of cardiovascular medicine at Mayo Clinic, said in a prepared statement. “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.”

“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,” added Ross Upton, DPhil, CEO and founder 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. 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.”

Regulatory Roundup: Updates on Medtronic and LivaNova recalls, FDA-cleared AI models, a new heart valve and more

VIDEO: An updated look at the use of AI in radiology

Radiologist examines AI's potential to transform medical imaging

FDA warns 7 companies for illegally selling dietary supplements that claim to treat CVD

Ultromics receives FDA Clearance for a first-of-kind solution in Echocardiography to help clinicians diagnose disease

FDA clears Ultromics’ AI-based CV image analysis system

Michael Walter, Managing Editor

Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.

Around the web

Health Exec

Major association of physicians presents itself as a go-to alternative vs. the government on vaccine expertise

One of the most formidable societies of medical professionals in the U.S. is going toe-to-toe with Robert F. Kennedy’s HHS over changing vaccination recommendations.

Health Exec

Tom Price: Medical residency slots need to expand to combat physician shortages

Tom Price, MD, former secretary of Health and Human Services (HHS), said one way to address the growing shortage of physicians is to expand medical resident positions, but these are tied to Medicare spending so alternative means may be needed.

Health Imaging

Tariffs will have a significant impact on the nuclear imaging supply chain in the US

"Domestic radiopharmaceutical suppliers, who receive isotopes from abroad, would be impacted by price changes and uncertainty caused by additional tariffs,” SNMMI President Cathy Cutler, PhD, wrote in a letter to the U.S. Department of Commerce this week.