Ultromics’ EchoGo Amyloidosis Platform Granted FDA Breakthrough Device Designation

April 26, 2023—Ultromics, a developer of artificial intelligence (AI)–powered diagnostics for heart failure, announced that FDA Breakthrough Device designation has been granted for its AI-enhanced platform for detecting cardiac amyloidosis. Ultromics’ EchoGo Amyloidosis platform uses AI to analyze echocardiograms and detect the presence of cardiac amyloidosis, using only a single commonly acquired ultrasound view of the heart. It is currently in development with the algorithm as a candidate for FDA medical device submission.

The platform is the company’s second technology to receive FDA Breakthrough Device designation within the last year. Its device for heart failure with preserved ejection fraction, EchoGo Heart Failure, received Breakthrough Device designation in 2022 and marketing authorization in 2023.

According to the company, the technology is designed to address the need for earlier diagnosis of amyloidosis, which otherwise may go unnoticed until the disease has advanced, delaying treatment, and adversely impacting patient outcomes.

The company noted that cardiac amyloidosis is a heterogeneous disease that can be difficult to diagnose, often requiring specialized expertise and testing. The disease is subclassified based on the specific protein involved, with the major subtypes being transthyretin amyloidosis (or, ATTR cardiac amyloidosis), caused by misfolding of the transthyretin protein, and a rarer form called light chain amyloidosis (or, AL cardiac amyloidosis), caused by accumulation of immunoglobulin light chains. Amyloidosis patients experienced a 5-year mortality of 44% to 65% after diagnosis, if not caught early enough.

EchoGo Amyloidosis, which is intended as a module within Ultromics’ EchoGo platform, has been developed with data from several leading clinical collaborators and with support from Janssen Biotech, Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson. The company is preparing regulatory submissions for the United States. The device could be approved for commercialization as soon as early 2024, advised Ultromics.

Najat Khan, PhD, who is Chief Data Science Officer and Global Head, Strategy & Operations at Janssen Research & Development, LLC, stated in Ultromics’ press release, “While treatments exist to help slow or halt the progression of cardiac amyloidosis, underdiagnosis in the early stages of disease is a huge challenge. 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.”