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Ultromics receives FDA clearance for its breakthrough device EchoGo Heart Failure

Press releases may be edited for formatting or style | December 09, 2022 Artificial Intelligence Cardiology Ultrasound

What is EchoGo® Heart Failure?

Echocardiography is the most widely used and highly valued cardiac imaging procedure. It provides rapid results, is portable, safe, and more cost effective than other imaging modalities. However, existing tools and measurement packages have limitations.

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Evaluating the presence or risk of HFpEF is extremely variable in current clinical practice. The average sensitivity and specificity to distinguish HFpEF is quite poor, estimated to be 74% and 65% respectively, with data taken from 9 key publications".7-15

These high missed diagnosis rates and current tools generally stop short of linking echocardiography findings to treatment interventions and patient pathways. Importantly, traditional echocardiography suffers from variability across all phases including image acquisition, measurement, and interpretation.

Ultromics harnesses the power of AI and takes HFpEF detection to the next level. The company strives to improve patient outcomes by enabling screening, precision diagnosis, and deep phenotyping of HFpEF that directly maps to treatment pathways.

EchoGo® Heart Failure aims to prevent HF hospitalizations and reduce mortality through better detection of HFpEF, and is therefore an integral part of that mission. Built in collaboration with the Mayo Clinic, this solution analyzes millions of pixels within a single echocardiogram to deliver precision detection of HFpEF.

90% accuracy in detecting HFpEF in the validation dataset;
87.8 % Sensitivity and 83% Specificity in the independent testing dataset;
68% more HFpEF patients correctly identified vs. clinical algorithms in the independent testing dataset.
HFpEF is a significant burden, and the solution needs to start with accurate diagnosis. Up until now we have lacked a gold standard, easy-to-use approach. But the FDA-cleared EchoGo® Heart Failure can help combat this commonly missed disease. The platform is the first HFpEF detection algorithm that will help support diagnosis and patient selection for therapy, ultimately improving quality of life and reducing the significant burden HFpEF has on healthcare.


About Ultromics:
Ultromics is a pioneer in advanced heart failure detection. The ground-breaking platform, EchoGo ®, is transforming the way heart failure is diagnosed using artificial intelligence and cardiac ultrasound as a modality. The technology empowers clinicians to make precise, efficient, and accurate assessments of heart failure, leveraging the largest known heart disease outcomes dataset in echocardiography, accurately interpreting echocardiograms and predicting cardiac outcomes. The technology has been built in collaboration with Mayo Clinic and NHS England, and has over $50 million raised capital to support continued innovation with the likes of Blue Venture Fund, Optum Ventures, Oxford Science Enterprises, and GV. They are backed by the largest US health insurance firms with 4 FDA clearances. Ultromics' mission is to stop heart failure in its tracks with its precision detection platform.


SOURCE Ultromics

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