InVision Medical Technology Corporation (“InVision”) has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its AI algorithm for detection of end stage liver disease through opportunistic findings in echocardiography. End stage liver disease or cirrhosis is a chronic condition resulting from permanent scarring of the liver due to long term data and at the earlier stages can present in symptoms of fatigue, weakness, poor appetite, leg and abdominal swelling that might be confused with heart failure.
The novel technology is designed to address the unmet need for earlier diagnosis of liver cirrhosis patients, which otherwise may go unnoticed until the disease has advanced, delaying treatment, and adversely impacting patient outcomes. The algorithm is designed to identify signs of liver disease from echocardiography. The Breakthrough Device Designation recognizes the significant potential of the InVision algorithm, and the designation is a key regulatory milestone providing an expedited pathway for development, assessment and regulatory review in the U.S.
Liver cirrhosis is a serious disease caused by permanent scarring of the liver from long term damage that might arise from obesity (metabolic dysfunction associated steatotic liver disease), chronic alcoholism, hepatitis, and other long term liver diseases. Without treatment, cirrhosis can lead to fluid build-up in the abdomen or legs, confusion, malnutrition and death1. Unfortunately, liver disease is often misdiagnosed or underdiagnosed in its earliest stages, given the lack of symptoms when compensated and the overlap of symptoms with heart failure. However, subtle signs can be identified in cardiovascular imaging and AI may aid clinicians with prompt diagnosis2. A prospective multi-center trial has been funded by the American Heart Association to evaluate the efficaciousness of this technology3.
“AI has the potential to identify signs of early disease missed by cardiologists, and may allow for timely detection of liver disease2.” said Dr. David Ouyang, MD, Co-founder of InVision. “Echocardiography is a key early exam in the cardiovascular care pathway, with unique potential for high specificity disease screening. During echocardiography, images of the liver are routinely obtained, however cardiologists are not trained to assess changes in liver texture and quality that can identify liver disease. The InVision team has led the development of numerous state of the art echo AI algorithms, with publications in Nature, Nature Medicine, Circulation, JACC, NEJM AI, and JAMA Cardiology. These many of these algorithms have been validated in clinical settings and we appreciate the support of the American Heart Association to perform clinical validation of novel AI technologies that can impact cardiovascular health.”
