UK-based health technology company Ultromics has teamed up with US-based pharmaceutical firm Pfizer to support the validation and regulatory approval of its AI-powered cardiac amyloidosis detection tool.
As part of the partnership, Ultromics will research and secure the US Food and Drug Administration (FDA) approval for its EchoGo Amyloidosis algorithm.
The algorithm received the FDA Breakthrough Device Designation in April last year, as a medical device for the detection of cardiac amyloidosis.
Cardiac amyloidosis is a heterogeneous disease caused due to the accumulation of abnormal proteins within the heart, worsening its ability to pump blood.
The build-up of proteins may cause the heart muscle to stiffen over time, leading to heart failure and may result in outcomes if not identified in early stages.
Ultromics’ EchoGo Amyloidosis algorithm leverages deep learning to analyse routine echocardiograms to detect the disease, which is often undetected during standard testing.
Ultromics founder and CEO Ross Upton said: “AI can notify clinicians of disease presence and offer an early warning. Early identification and treatment of cardiac amyloidosis is critical to help slow disease progression.
“If cleared, EchoGo Amyloidosis will help physicians identify early signs of this debilitating disease, with the goal of facilitating earlier diagnosis and access to potentially life-saving treatment.”
Ultromics is developing an advanced EchoGo platform, which is transforming the way heart failure is diagnosed using artificial intelligence and cardiac ultrasound as a modality.
The company’s first AI-powered diagnostic system EchoGo Pro, intended to detect coronary artery disease, was approved by the US FDA in 2021 and is undergoing a clinical trial in the UK.
Its algorithm to improve detection of Heart Failure has previously received FDA Breakthrough Device Designation and was approved by the FDA in November 2022.
In December last year, Ultromics was selected to participate in the FDA’s Total Product Life Cycle Advisory Program (TAP) Pilot of 15 breakthrough cardiovascular devices.
The initiative aims to advance the development and enhance the accessibility of high-quality, safe, effective, and innovative medical devices.
