Ultromics has secured FDA clearance for its EchoGo® Amyloidosis, an AI-driven diagnostic tool designed to enhance the early detection of Cardiac Amyloidosis. This condition, often underdiagnosed as a cause of heart failure, can now be identified more efficiently using standard echocardiogram images. The clearance marks a significant milestone as EchoGo® Amyloidosis is the first device from the FDA’s Total Product Lifecycle Advisory Program (TAP) to achieve marketing authorization.
Advancing Cardiac Amyloidosis Detection
Cardiac Amyloidosis is characterized by the accumulation of abnormal amyloid fibrils in the heart's extracellular matrix, leading to restrictive cardiomyopathy. Early detection is crucial, as patients diagnosed at end-stage disease have significantly shorter survival times compared to those diagnosed early. However, the non-specific presentation of Cardiac Amyloidosis often leads to missed or delayed diagnoses, particularly in patients with heart failure with preserved ejection fraction (HFpEF).
EchoGo® Amyloidosis addresses these challenges by leveraging artificial intelligence to analyze routinely acquired echocardiogram images. Requiring only a single apical 4-chamber view, the device identifies potential cases with high accuracy, even in clinical settings with limited expertise or resources.
Clinical Performance and Validation
Clinical data from the FDA submission demonstrated that EchoGo® Amyloidosis achieved 84.5% sensitivity and 89.7% specificity in detecting Cardiac Amyloidosis within a target population of individuals aged 65 and older with heart failure. Consistent performance was observed across various Amyloidosis subtypes, including AL Amyloidosis (84.4% sensitivity), Wild-type Transthyretin Amyloidosis (TTRwt) (85.8% sensitivity), and Hereditary Transthyretin Amyloidosis (TTRv) (86.3% sensitivity).
In a matched subgroup analysis, EchoGo® Amyloidosis maintained excellent diagnostic performance, achieving 83.4% sensitivity and 90.6% specificity when compared to phenotypically similar controls. The device also demonstrated 100% repeatability, ensuring consistent diagnostic outcomes.
Integration and Scalability
EchoGo® Amyloidosis is designed for seamless integration into existing clinical workflows. As a software-only solution, it requires no additional hardware and operates on a Software-as-a-Service (SaaS) model, making it highly scalable and rapidly deployable. The device complements Ultromics’ existing EchoGo® Heart Failure device, providing a comprehensive solution for diagnosing heart failure and its underlying causes.
"Improving the detection of Cardiac Amyloidosis is vital as early detection provides the greatest therapeutic benefit for patients," said Prof. Sanjiv J. Shah, MD, Northwestern University. "Novel AI-based diagnostic tools such as EchoGo® Amyloidosis from Ultromics should help facilitate disease identification, particularly in clinics and hospitals restricted by expertise and resource."
Collaborative Development
The development of EchoGo® Amyloidosis was supported by Janssen Biotech, Inc., a Johnson & Johnson Company, and Pfizer, reflecting their commitment to improving the diagnosis and clinical outcomes of Cardiac Amyloidosis. Janssen supported the development of the device, while Pfizer supported expediting the performance testing and validation ahead of the regulatory submission.
With its FDA clearance, EchoGo® Amyloidosis is poised to transform the landscape of Cardiac Amyloidosis diagnosis, enabling earlier detection, improved patient outcomes, and more efficient use of healthcare resources.
