# InVision Medical Technology

> FDA-cleared AI for echocardiography. InVision Precision Cardiac Amyloid flags echocardiograms suggestive of cardiac amyloidosis for referral to confirmatory testing; Precision LVEF measures ejection fraction. Standard DICOM in, from any scanner, deployed on-premise or in a validated US cloud.

InVision Precision Cardiac Amyloid (FDA 510(k) K243866, cleared 21 May 2025, product code SDJ, Rx only) is decision-support software for adults aged 65 and over undergoing echocardiography. It flags studies suggestive of cardiac amyloidosis for referral to confirmatory testing; it does not diagnose, and patient-management decisions should not rest on its result alone. 510(k) validation: sensitivity 60.7%, specificity 99.0% (1,221 studies, 3 US sites); positive predictive value depends on prevalence. It has the highest specificity and positive predictive value, and the broadest cleared indication, of any FDA-cleared echo AI for cardiac amyloidosis: adults aged 65 and over undergoing echocardiography, with no heart-failure or wall-thickness prerequisite. Highest specificity and PPV: cross-study comparison of the FDA 510(k) summaries, PPV compared at equal prevalence. Broadest indication: among FDA-cleared echo-AI devices for cardiac amyloidosis. As of October 2026.

## Products
- [Precision Cardiac Amyloid](https://invisionmedtech.com/product/cardiac-amyloid/): FDA-cleared AI that flags echocardiograms suggestive of cardiac amyloidosis, from routine transthoracic echocardiography (A4C and PLAX views).
- [Precision LVEF](https://invisionmedtech.com/product/lvef/): AI measurement of left ventricular ejection fraction from echocardiography.
- [Automatic Deidentification](https://invisionmedtech.com/product/deidentification/): automated removal of protected health information from echo studies.

## Evidence
- [Comparing FDA-cleared echo AI for cardiac amyloidosis](https://invisionmedtech.com/evidence/amyloid-ai-comparison/): specificity, positive predictive value, and the cleared indication, at equal prevalence.
- [How AI detects cardiac amyloidosis on an echocardiogram](https://invisionmedtech.com/evidence/how-ai-detects-cardiac-amyloidosis/): a plain-language explainer of the method and what the result means.
- [Seven questions to ask any amyloid-AI vendor](https://invisionmedtech.com/evidence/comparing-amyloid-ai/): how to evaluate echo-AI amyloidosis devices.
- [Full amyloid evidence](https://invisionmedtech.com/product/amyloid-evidence/): the published performance figures, including where the model scores lower.
- [Research and publications](https://invisionmedtech.com/evidence/research/): peer-reviewed research behind the products.

## Reimbursement
- [Coding and reimbursement overview](https://invisionmedtech.com/reimbursement/): CPT Category III code 0932T (outpatient, when the analyzed echo shows preserved ejection fraction, 50% or above) and the Medicare New Technology Add-on Payment (inpatient, up to $2,275 per qualifying stay, traditional Medicare at IPPS hospitals, effective 1 October 2026). Coverage and payment are determined by the applicable payer.

## Trust and security
- [Trust and security](https://invisionmedtech.com/trust/): SOC 2 Type II, HIPAA with a business associate agreement, the on-premise option (no image data retained), and US-only data residency.

## Deployment
- [Deployment and integration](https://invisionmedtech.com/deployment/): DICOM integration with the existing PACS, on-premise or validated US cloud.

## Company
- [Blog](https://invisionmedtech.com/blog/)
- [Press](https://invisionmedtech.com/press/)