Ultromics granted FDA breakthrough device designation for AI-enhanced cardiac amyloidosis detection

Press releases may be edited for formatting or style | April 28, 2023 Artificial Intelligence Cardiology

"While treatments exist to help slow or halt the progression of cardiac Amyloidosis, underdiagnosis in the early stages of disease is a huge challenge," said Najat Khan, Ph.D., Chief Data Science Officer and Global Head, Strategy & Operations at Janssen Research & Development, LLC. "When applied to routine tests like echocardiograms, artificial intelligence is demonstrating exciting potential to help facilitate earlier disease detection – with the goal of connecting patients with treatment sooner and, ultimately, driving better health outcomes."

Ultromics' Amyloidosis platform is the company's second technology to receive FDA Breakthrough Device Designation within the last year. Its HFpEF device, EchoGo Heart Failure received Breakthrough Device Designation in 2022 and Marketing Authorization in 2023. EchoGo Amyloidosis is currently in development with the algorithm as a candidate for FDA medical device submission.

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.

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