Ultromics scores FDA 510(k) for AI-based heart failure detection aide


UK-based Ultromics announced Tuesday its machine learning-based decision support system used to help detect heart failure with preserved ejection fraction received FDA 510(k) clearance.

EchoGo Heart Failure, which was developed in partnership with the Mayo Clinic, aids physicians in diagnosing the condition using echocardiogram imaging results in people over 25 years old. 

In patients with heart failure with preserved ejection fraction, the amount of blood pumped from the left ventricle remains within a normal range. Nearly half of patients with heart failure have preserved ejection fraction, and the condition can be difficult to diagnose

“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. Patricia A. Pellikka, vice chair of the department of cardiovascular medicine at Mayo Clinic, said in a statement.


According to the FDA’s database, Ultromics has received four 510(k) clearances with the latest green light. It received its first 510(k) in 2019 for its EchoGo Core cardiovascular imaging analysis system. 

The University of Oxford spinout raised $33 million in Series B funds last year, and it scooped up $10 million in 2020. Ultromics first announced its partnership with the Mayo Clinic that same year.

Mayo Clinic has been expanding its investment in cardiovascular AI. In 2021, Mayo Clinic partnered to launch two AI-based companies, including cardiology-focused Anumana. The joint venture between the clinic and EHR data company nference recently received Breakthrough Device Designation for an ECG-based AI algorithm designed for early detection of pulmonary hypertension.

It has also partnered with Novartis to develop artificial intelligence tools to detect cardiovascular diseases and recently acquired NeuTrace, which focused on developing AI applications for assessing electrical signals in the heart.


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