Ultromics has introduced an AI-enhanced tool for the detection of cardiac amyloidosis, a disorder characterized by abnormal protein deposits in heart tissue.
The U.S. Food and Drug Administration (FDA) has granted breakthrough status to this device.
The platform, called EchoGo Amyloidosis, utilizes artificial intelligence to analyze echocardiograms and diagnose the presence of cardiac amyloidosis using a single ultrasound image of the heart, commonly captured during routine examinations.
This innovative technology aims to address the existing need for early detection of amyloidosis patients who often go undiagnosed until the disease has progressed, resulting in delayed treatment and unfavorable patient outcomes.
Cardiac amyloidosis is a complex condition that poses challenges in detection, requiring specialized knowledge and testing. It encompasses two primary subtypes: transthyretin amyloidosis (ATTR cardiac amyloidosis), caused by misfolded transthyretin protein, and a rarer form known as light chain amyloidosis (AL cardiac amyloidosis), characterized by the accumulation of immunoglobulin light chains.
The module, designed to integrate into Ultromics EchoGo Platform, has been developed through collaborations with esteemed clinical partners and the support of Janssen Biotech, Inc., a subsidiary of the Janssen Pharmaceutical Companies of Johnson & Johnson. Leveraging data from these collaborations, the device has been tailored to address the specific challenges associated with diagnosing and managing amyloidosis.
Ultromics is currently working on regulatory filings for the United States and aims to potentially launch the device on the market as early as 2024.
This marks Ultromics second FDA Breakthrough Device Designation within a short period, following the successful launch of EchoGo Heart Failure, a device targeting HFpEF (heart failure with preserved ejection fraction) that obtained Marketing Authorization in 2023, following its Breakthrough Device Designation in 2022.
EchoGo Amyloidosis is currently in the development phase as a potential candidate for FDA medical device submission, incorporating Ultromics advanced algorithm.