InVision Precision Cardiac Amyloid
Flags echocardiograms suggestive of cardiac amyloidosis — a rare, underdiagnosed, and now-treatable disease — from routine transthoracic echocardiography. Decision-support AI for adults aged 65 and older.
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. Coverage and payment are determined by the applicable payer. Development was supported by Alexion, AstraZeneca Rare Disease.
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.
Frequently asked questions
What does InVision Precision Cardiac Amyloid do?
It is FDA 510(k)-cleared decision-support AI that analyzes a standard transthoracic echocardiogram and flags studies suggestive of cardiac amyloidosis, alerting the interpreting physician for referral to confirmatory testing. It reads the apical-4-chamber and parasternal-long-axis views already captured in a routine echo. It does not diagnose, and patient-management decisions should not rest on its result alone.
Is InVision Precision Cardiac Amyloid FDA cleared?
Yes. It was cleared under FDA 510(k) K243866 on 21 May 2025 (product code SDJ, Class II, prescription use). It was previously granted FDA Breakthrough Device Designation and is enrolled in the FDA Total Product Lifecycle Advisory Program (TAP).
How accurate is it?
In the 510(k) validation study, specificity was 99.0% and sensitivity was 60.7% across 1,221 studies at three US sites. Positive predictive value depends on how common amyloidosis is in the population assessed. External peer-reviewed validation across five sites in two countries (Duffy 2025, JACC: Advances) reports consistent performance.
Does it diagnose cardiac amyloidosis?
No. InVision Precision Cardiac Amyloid is decision-support AI; no InVision output is a diagnosis. It flags echoes suggestive of cardiac amyloidosis so the interpreting physician can refer the patient for confirmatory testing. The physician makes the diagnosis.
Which types of cardiac amyloidosis is it validated for?
It is validated in both AL and ATTR cardiac amyloidosis in the peer-reviewed external validation (Duffy 2025).
Which echocardiographic views does it need?
Two standard views from a routine transthoracic echo: apical-4-chamber (A4C) and parasternal-long-axis (PLAX). No additional acquisition or special protocol is required.
How does it fit into the reading workflow?
The result returns into the originating study as a DICOM secondary capture, available to the reader as the last frame, and can also populate a structured report field or a positives worklist. On-premise, turnaround is a median of 0 minutes from study completion (75th percentile 2 minutes, maximum 10 minutes).
Can it run on-premise so patient data never leaves our network?
Yes. InVision can run on-premise inside your data center, where all inference runs locally and no image data is retained after processing, or in a validated US cloud. Both models keep customer data in the United States.
What makes InVision Precision Cardiac Amyloid distinctive?
It has the highest specificity (99.0%, sensitivity 60.7%) and the highest positive predictive value of any FDA-cleared echo AI for cardiac amyloidosis, so at realistic prevalence a flagged study is far more likely to be amyloid — about 2 in 5 flags are amyloid at 1% prevalence. It also has the broadest cleared indication of any FDA-cleared echo AI for cardiac amyloidosis — the only one with no heart-failure or wall-thickness prerequisite, applying to adults aged 65 and older undergoing echocardiography. Positive predictive value depends on prevalence; figures are from the FDA 510(k) summaries.
Is there reimbursement for it?
A Medicare inpatient New Technology Add-on Payment of up to $2,275 per qualifying stay (traditional Medicare, IPPS hospitals) applies on top of the MS-DRG payment, effective 1 October 2026. CPT Category III code 0932T applies to outpatient studies when the analyzed echo shows preserved ejection fraction (50% or above), with physician interpretation and report. This is general educational information; coverage and payment are determined by the applicable payer.
What are the intended use and key limitations?
InVision Precision Cardiac Amyloid (FDA 510(k) K243866) is decision-support software for adults aged 65 and older undergoing echocardiography. It alerts the interpreting physician for referral to confirmatory testing; it does not diagnose, and patient-management decisions should not rest on its result alone. In the 510(k) validation, sensitivity was 60.7% and specificity was 99.0%; positive predictive value depends on prevalence. Prescription use only.
510(k) validation: 1,221 unique echocardiogram studies, 3 US sites. Highest specificity and PPV: comparison of the FDA 510(k) summaries of FDA-cleared echo-AI devices for cardiac amyloidosis; cross-study, different study populations; PPV compared at equal prevalence. Broadest indication: among FDA-cleared echo-AI devices for cardiac amyloidosis; InVision's cleared indication has no heart-failure or wall-thickness requirement for adults 65 and over. As of October 2026.