FDA 510(k) Cleared Breakthrough Device FDA TAP Enrolled CPT 0932T

InVision Precision Cardiac Amyloid

AI screening for cardiac amyloidosis — a rare, underdiagnosed, and now-treatable disease — from routine transthoracic echocardiography.

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What it does.

Cardiac amyloidosis is a life-threatening, rare disease that is often misdiagnosed or underdiagnosed because its symptoms overlap with other causes of heart failure. With the emergence of disease-modifying therapies, timely and accurate detection has direct consequences for patient outcomes.

InVision Precision Cardiac Amyloid uses AI to evaluate features of cardiac amyloidosis across transthoracic echocardiogram studies containing apical-4-chamber and parasternal-long-axis view videos. Unlike single-view approaches, the algorithm integrates information across multiple standard echocardiographic views to assess amyloid-associated features holistically.

The underlying algorithm was peer-reviewed and published in JAMA Cardiology in 2022, previously received FDA Breakthrough Device Designation, and was enrolled in the FDA's Total Product Lifecycle Advisory Program (TAP). The American Medical Association has adopted CPT Category III code 0932T (effective January 1, 2025) for adjunctive technologies assisting clinicians in diagnosing and assessing patients with heart failure symptoms — providing a concrete reimbursement pathway. Development was supported by Alexion, AstraZeneca Rare Disease.

2+
Standard echocardiographic views integrated for holistic assessment
0932T
CPT Category III reimbursement code effective January 1, 2025
510(k)
FDA-cleared Software as a Medical Device for adult patients

Peer-reviewed research behind the product.

Built for your existing workflow.

Indication
Detection of cardiac amyloidosis in adult patients
Input
Transthoracic echocardiography with A4C and PLAX view videos
Output
Risk assessment for cardiac amyloidosis
Regulatory
FDA 510(k) cleared · Previously granted Breakthrough Device Designation · FDA TAP enrollee
Reimbursement
Covered by CPT Category III code 0932T (effective Jan 1, 2025)
Partnership
Developed with support from Alexion, AstraZeneca Rare Disease