Ultromics has unveiled EchoGo Amyloidosis, an AI-enhanced platform for the detection of cardiac amyloidosis, a condition characterized by abnormal protein deposits in the heart tissue.
The U.S. Food and Drug Administration (FDA) has granted breakthrough status to this innovative tool.
By leveraging artificial intelligence, EchoGo Amyloidosis can analyze echocardiograms and accurately diagnose cardiac amyloidosis using a single ultrasound image, typically obtained during routine examinations.
This cutting-edge technology aims to address the challenge of early detection, as many amyloidosis patients remain undiagnosed until the disease has progressed, leading to delayed treatment and unfavorable outcomes.
The platform focuses on two primary subtypes of cardiac amyloidosis: transthyretin amyloidosis (ATTR cardiac amyloidosis) and light chain amyloidosis (AL cardiac amyloidosis).
Ultromics has developed this module in collaboration with renowned clinical partners and with the support of Janssen Biotech, Inc., a subsidiary of the Janssen Pharmaceutical Companies of Johnson & Johnson.
The device, integrated into Ultromics EchoGo Platform, has been tailored to address the unique challenges associated with diagnosing and managing amyloidosis.
Ultromics is currently preparing regulatory submissions for the United States, with a potential market debut in 2024.
Ultromics previously received FDA Breakthrough Device Designation for EchoGo Heart Failure, a device that treats heart failure with preserved ejection fraction (HFpEF).
EchoGo Amyloidosis is currently being developed as a prospective FDA medical device submission candidate, demonstrating Ultromics commitment to using innovative algorithms in the field of cardiac imaging and diagnostics.
