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

InVision Precision Cardiac Amyloid

Adjunctive AI detection of cardiac amyloidosis — a rare, underdiagnosed, and now-treatable disease — from routine transthoracic echocardiography. Cleared as a diagnostic aid for adults aged 65 and older.

99.0%Specificity · K243866
0.954PPV · peer-reviewed validation
5Sites, two countries
ROUTINE ECHO VOLUME AMYLOID FLAGGED ROUTINELY MISSED

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.

Published in the peer-reviewed literature as EchoNet-LVH — the same model as InVision Precision Cardiac Amyloid. The literature uses the research name; the FDA clearance uses the product name. See every figure, including where we score lower →

Built for your existing workflow.

Indication
Adjunctive detection of cardiac amyloidosis in adults aged 65 and older. Cleared as a diagnostic aid, not a screening aid.
Input
Transthoracic echocardiography with A4C and PLAX view videos
Performance
Sensitivity 0.607, specificity 0.990 in FDA validation (1,221 unique echocardiogram studies, 3 US sites). See the full evidence, including where we score lower →
Output
Risk assessment for cardiac amyloidosis, returned as a DICOM secondary capture into the originating study — available to the reader as the last frame. Can also populate a structured report field or a positives worklist.
Turnaround
Median 0 minutes from study completion (the result is typically ready before the study ends), 75th percentile 2 minutes, maximum 10 minutes. On-premise.
Deployment
Cloud or on-premise. On-premise, all inference runs locally and no image data is retained after processing. See deployment & integration →
Implementation
About four weeks from kick-off to go-live, led by a named InVision Forward Deployed Engineer
Regulatory
FDA 510(k) cleared · Previously granted Breakthrough Device Designation · FDA TAP enrollee
Reimbursement
CPT Category III code 0932T (effective Jan 1, 2025), in scope when LVEF is 50% or above. Precision LVEF establishes that threshold in the same pass. Reimbursement detail →
Partnership
Developed with support from Alexion, AstraZeneca Rare Disease