InVision Medical Technology Corporation (“InVision”) has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its AI algorithm for echocardiography designed to aid in the early identification of cardiac amyloidosis, a life-threatening, rare, underdiagnosed disease.
The novel technology is designed to address the unmet need for earlier diagnosis of amyloidosis patients, which otherwise may go unnoticed until the disease has advanced, delaying treatment, and adversely impacting patient outcomes. The algorithm is designed to go beyond a single ultrasound view of the heart and holistically assess features of cardiac amyloidosis. 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..
Cardiac amyloidosis is characterized by a build-up of amyloid in the heart — without treatment, it can lead to heart failure and death.1 Unfortunately, cardiac amyloidosis is often misdiagnosed or underdiagnosed, given the overlap of symptoms with other etiologies of heart failure. However, subtle signs can be identified in cardiovascular imaging and AI may aid the cardiologist with prompt diagnosis.2
“AI has the potential to improve access to care, and may allow for timely detection of cardiac amyloidosis.”3 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. We aspire to prevent misdiagnosis of rare diseases , and enable broad access to expert care for patients. The InVision team has led the development of numerous state of the art echo AI algorithms, with publications in Nature, Nature Medicine, and JAMA Cardiology. These algorithms have been validated in clinical settings, including a first of its kind blinded, randomized clinical trial that was published in Nature 2023.”
InVision previously announced a multi-year collaboration agreement with Alexion, AstraZeneca Rare Disease (“Alexion”) to develop an artificial intelligence (AI)algorithm for analysis of routine echocardiograms, with the aim to accelerate early detection of patients with amyloidosis with cardiac involvement.
