Ultromics' EchoGo® Amyloidosis is an AI-based tool designed for echocardiography. This milestone makes it the first device enrolled in the FDA's Total Product Lifecycle Advisory Program (TAP) to receive marketing authorisation.
The device is the first available software-only product that aids in the detection of Cardiac Amyloidosis using echocardiography.
Unlike current methods, EchoGo® Amyloidosis requires only a single routine echocardiographic clip and significantly less clinical information to detect the disease.
EchoGo® Amyloidosis is designed to enhance the detection of Cardiac Amyloidosis, which can be difficult to identify, even for experienced clinicians.
The device uses a single apical 4-chamber echocardiogram to flag potential cases of Cardiac Amyloidosis, offering earlier access to appropriate treatments for patients suffering from this underdiagnosed condition.
Cardiac Amyloidosis is a condition where abnormal proteins form amyloid fibrils that deposit in the heart, causing restrictive cardiomyopathy.
The main types of Cardiac Amyloidosis are transthyretin (ATTR) and immunoglobulin light chains (AL). Both are systemic diseases, meaning they can affect multiple organs, including the heart, kidneys, eyes, gastrointestinal system, and nervous system.
EchoGo® Amyloidosis is designed to address these diagnostic challenges. By using a single standard echocardiogram, it can assist clinicians in identifying potential cases more accurately and efficiently.
This AI-powered tool complements such as the EchoGo® Heart Failure tool and is part of a broader effort to provide accurate, timely diagnosis and facilitate earlier access to life-saving treatments.
The device also showed consistent performance across different subtypes of Amyloidosis, including AL and both wild-type and hereditary transthyretin (ATTR).
EchoGo® Amyloidosis is designed to be easily integrated into clinical workflows, using existing echocardiography equipment and requiring no additional hardware.
Source: https://www.prnewswire.com/news-releases/ultromics-obtains-breakthrough-device-fda-clearance-for-its-cardiac-amyloidosis-screening-device-through-the-total-product-lifecycle-advisory-program-302311450.html
