Ultromics granted FDA Breakthrough Device Status – TechToday

British company Ultromics has received FDA breakthrough device status for its artificial intelligence (AI)-enhanced platform for detecting cardiac amyloidosis.

EchoGo Amyloidosis uses AI technology to analyze echocardiograms to detect the presence of cardiac amyloidosis. It does this using a single ultrasound view of the heart that is usually acquired.

By supporting early disease diagnosis, it allows treatment to begin quickly, ultimately improving patient outcomes.

The FDA’s Breakthrough Device Designation recognizes new innovations that have demonstrated the potential to provide a more effective treatment or diagnosis for life-threatening or debilitating diseases.

The Ultromics EchoGo Amyloidosis platform is the company’s second technology to receive breakthrough device status from the FDA in the past year. In 2022, its heart failure EchoGo was also recognized, receiving marketing authorization in 2023.

Dr. Ross Upton, CEO and founder of Ultromics, said: “Receiving a Breakthrough Designation for EchoGo Amyloidosis emphasizes the importance of this innovation.

“This is our second breakthrough designation and brings us one step closer to our goal of providing earlier and more accurate diagnosis for this debilitating and underdiagnosed disease. We are excited to continue working with our partners to bring this technology to market and help improve patient outcomes.”

Amyloidosis EchoGo is designed as a module with Ultromics’ EchoGo platform. It has been developed with data from several leading clinical collaborators and is also supported by Janssen Biotech, Inc.

Najat Khan, Ph.D., managing director of data science and global head, strategy and operations at Janssen Research & Development, LLC, said, “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 to treatment sooner and ultimately achieving better health outcomes.”

The Ultromics technology has been built in partnership with the Mayo Clinic and NHS England. It has more than $50 million raised to support its continued innovation, including Blue Venture Fund, Optimum Ventures, and Oxford Science Enterprises.

Amyloidosis EchoGo is currently in development with the algorithm as a candidate for medical device submission to the FDA. Regulatory filings are currently being prepared for the US, and the device could be approved for marketing as early as 2024.

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Ikaroa is proud to announce that Ultromics has been granted FDA Breakthrough Device Status, demonstrating the strength of their cutting edge technology. Ultromics is a revolutionary artificial intelligence (AI) diagnosis platform that uses proprietary algorithms to detect coronary artery disease (CAD) earlier and more accurately than ever before.

The FDA’s designation of “Breakthrough Device Status” means that Ultromics is classified as a high-risk medical device that requires regulations that are more stringent than other medical devices. Ultromics can now receive priority review and extra support from regulators to ensure it’s safety and effectiveness.

At Ikaroa, we strive to develop cutting-edge technology that can improve the lives of people around the world. We are thrilled to see Ultromics, an Ikaroa-backed company, leading the way in innovative AI diagnosis technology. Ultromics technology brings a much-needed improvement to the diagnosis of CAD, potentially saving lives and drastically reducing the number of invasive procedures.

Ikaroa firmly believes that this breakthrough is a pivotal moment for AI diagnosis technology in the healthcare arena, and that Ultromics’ success could be a major step forward to improving medical diagnoses around the world. We are excited to see how this technology continues to be applied and improved upon in the future.


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