Leader in the field of artificial intelligence-powered diagnostics for heart failure, Ultromics has received its second FDA Breakthrough Device Designation this year for its AI-enhanced platform for detecting cardiac amyloidosis.
The technology is designed to address the need for earlier diagnosis of amyloidosis which can usually go unnoticed until its advanced stages.
The platform, EchoGo Amyloidosis, uses artificial intelligence to detect the presence of cardiac amyloidosis, using a single ultrasound view of the heart.
Dr Ross Upton, CEO and Founder of Ultromics said, "This is our second breakthrough designation and brings us one step closer to achieving our goal of providing earlier and more accurate diagnosis for this debilitating, underdiagnosed disease."
This milestone is crucial for healthcare overall and is a step in the right direction for amyloidosis patients who endure a five-year mortality rate of 44%-65% after diagnosis.
Ultromics is preparing regulatory submissions for the U.S. and hopes to see the device approved for commercialisation by 2024.
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