InVision Medical Technology Corporation (“InVision”) has received the US Food and Drug Administration (FDA) 510k clearance for InVision Precision Cardiac Amyloid, an Artificial Intelligence (AI ) Software as a Medical Device (SaMD) for echocardiography for the detection of cardiac amyloidosis. InVision Precision Cardiac Amyloid had previously received the US FDA Breakthrough Device Designation and was enrolled in the FDA’s Total Product Lifecycle Advisory Program (TAP).
Cardiac amyloidosis is a life-threatening, rare disease that is often misdiagnosed or underdiagnosed, given the overlap of symptoms with other etiologies of heart failure. InVision Precision Cardiac Amyloid uses AI to detect cardiac amyloidosis with evaluation of transthoracic echocardiogram studies containing apical-4-chamber and parasternal-long-axis view videos. The AI algorithm has undergone peer review and was published in JAMA Cardiology in 20221. The novel technology is designed to address the unmet need for earlier detection of cardiac amyloidosis patients, which otherwise may go unnoticed until the disease has advanced, delaying treatment and adversely impacting patient outcomes.
Furthermore, the American Medical Association has adopted a new Category III Current Procedural Terminology (CPT) code for adjunctive technologies assisting clinicians in diagnosing and assessing patients with heart failure symptoms. The new CPT code, 0932T, became effective January 1, 2025.
“Echocardiography is a key early exam in the cardiovascular care pathway, with unique potential for early disease detection,” said Dr. David Ouyang, MD, Co-founder of InVision. “Because cardiac amyloidosis is a rare disease, it can be overlooked in a busy clinical practice or echocardiography lab. With AI assistance, we aspire to prevent misdiagnosis or underdiagnosis, democratize expert knowledge to more clinicians, and ensure that expert care is available to more patients.”
This development was made with support from Alexion, AstraZeneca Rare Disease, with the aim to accelerate early detection and reduce misdiagnosis of patients with cardiac amyloidosis. Subtle signatures that can be identified with AI in routine imaging can aid detection. Seng Cheng, PhD, Senior Vice President, Head of Research and Product Development, Alexion, said: “Signs and symptoms of cardiac amyloidosis can resemble those of other more common diseases, often leading to delayed diagnoses or misdiagnoses and resulting in poor prognosis or incorrect treatment options. Employing AI in echocardiogram may help assist in timely and accurate detection and therefore improve outcomes for people living with this progressive disease.”
