InVision Precision Cardiac Amyloid

by InVision Medical Technology  · Based in United States → — AI for Echocardiography
Cardiology Radiology
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Regulatory Status Disclosed

Overview

InVision Precision Cardiac Amyloid by InVision Medical Technology Corporation is an AI-powered software designed to aid clinicians in the evaluation of echocardiogram studies for cardiac amyloidosis, including both AL and ATTR types.

This tool is intended for use by cardiologists and other healthcare professionals in various care settings, particularly echocardiography laboratories within health systems.

The software integrates into existing clinical workflows by analyzing standard DICOM echocardiogram images (specifically apical-4-chamber and parasternal-long-axis views) as a post-processing analysis. It is designed to deploy alongside existing PACS, Epic EHR, and structured reporting platforms, without requiring new hardware or scanners. The aim is to flag patients with a high suspicion for cardiac amyloidosis for further consideration by clinicians, thereby assisting in earlier detection of a condition that can be underdiagnosed.

Notable capabilities include its FDA 510(k) clearance and its ability to analyze routine echocardiograms to identify potential cardiac amyloidosis. It was previously granted Breakthrough Device Designation by the FDA. A CPT Category III code (0932T), effective January 1, 2025, supports AI-assisted echocardiographic evaluation for patients with heart failure symptoms, which includes Precision Cardiac Amyloid.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered detection of cardiac amyloidosis
  • Evaluation of transthoracic echocardiogram studies (apical-4-chamber and parasternal-long-axis view videos)
  • Aids clinicians in diagnosing and assessing patients with heart failure symptoms
  • Designed for earlier detection and reduction of misdiagnosis
  • Supports both AL and ATTR Cardiac Amyloidosis
  • Evidence-based AI algorithm, peer-reviewed and published in JAMA Cardiology
  • Integration into clinical workflow
  • Precise assessment of wall thickness in parasternal long axis view
  • Computer vision risk assessment in apical 4 chamber view
  • No racial bias in AI model output

Use Cases

  • Diagnosing and assessing heart disease risk (specifically cardiac amyloidosis)
  • Early detection of cardiac amyloidosis in patients with heart failure symptoms
  • Streamlining interpretation of heart ultrasounds
  • Identifying undiagnosed cardiac amyloidosis
  • Aiding clinicians in busy echocardiography labs
  • Personalizing treatment and prevention recommendations

What Physicians Need to Know

Echocardiography AI Features
InVision Precision Cardiac Amyloid uses AI to analyze transthoracic echocardiogram videos, specifically apical-4-chamber and parasternal-long-axis views, to identify signs of cardiac amyloidosis. The algorithm integrates information across multiple standard echocardiographic views for a holistic assessment of amyloid-associated features. It is designed to detect cardiac amyloidosis from routine echocardiograms, turning existing exam volume into a population-health instrument.
Heart Failure Risk Prediction
The tool aids in the early detection of cardiac amyloidosis, a condition that often leads to heart failure if undiagnosed and untreated. By identifying patients at high suspicion for cardiac amyloidosis, it helps clinicians refer them for confirmatory testing, which is crucial for timely intervention given the availability of disease-modifying therapies.
AHA/ACC Guideline Alignment
The underlying algorithm was peer-reviewed and published in JAMA Cardiology in 2022. The product has received FDA Breakthrough Device Designation and is 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, which includes InVision Precision Cardiac Amyloid when LVEF is 50% or above.
Real-Time Alert Capability
The software provides a risk assessment for cardiac amyloidosis, which can be returned as a DICOM secondary capture into the originating study, often available to the reader as the last frame. It can also populate a structured report field or a positives worklist. The median turnaround time from study completion is 0 minutes, with 75th percentile at 2 minutes and a maximum of 10 minutes, meaning the result is typically ready before the study ends.
Arrhythmia Detection Accuracy
While cardiac amyloidosis can lead to electrical abnormalities and heart failure, the InVision Precision Cardiac Amyloid tool is specifically designed for the detection of cardiac amyloidosis from echocardiograms and does not explicitly detail arrhythmia detection accuracy.
Cardiac CT/MRI Analysis
The InVision Precision Cardiac Amyloid tool focuses on echocardiogram analysis for cardiac amyloidosis detection. It does not currently offer features for Cardiac CT or MRI analysis.
ECG/EKG Analysis Capability
The InVision Precision Cardiac Amyloid tool analyzes echocardiogram videos. While AI-enabled ECG tools exist for detecting cardiac amyloidosis, InVision Precision Cardiac Amyloid's primary function is based on echocardiography.
Cardiac Monitoring Integration
The InVision Precision Cardiac Amyloid is a Software as a Medical Device (SaMD) that integrates with existing hospital imaging systems, including PACS, CVIS, and Epic EHR. It processes standard DICOM echo studies from various scanner vendors like GE, Philips, Siemens, Canon, and handheld POCUS.
Physician Tip

InVision Precision Cardiac Amyloid is an adjunctive diagnostic aid for adult patients aged 65 and over undergoing cardiovascular assessment using echocardiography. It is crucial to remember that patient management decisions should not be made solely based on the results of this tool; it provides information to alert the physician for referral to confirmatory investigations. A negative result does not exclude cardiac amyloidosis due to its sensitivity of 60.7%. The tool is designed to surface cardiac amyloidosis from routine echocardiograms, especially since the disease is often misdiagnosed or underdiagnosed. The results are typically available very quickly, often before the echocardiogram study is even finished.

InVision Precision Cardiac Amyloid is designed for seamless integration into existing clinical workflows. It is deployed as a third-party application that sits behind the picture archive and reads studies as they land. It is compatible with standard DICOM imaging systems from major vendors like GE, Philips, Siemens, Canon, and handheld POCUS. The software can be deployed either in the cloud or on-premise, with on-premise deployments ensuring that no image data is retained once processing is complete and PHI never leaves the user's network. It integrates with PACS, CVIS, and Epic EHR systems. The result can be returned as a DICOM secondary capture, populate a structured report field, or a positives worklist.

Details

Category Cardiology AI
Pricing Unknown
DeploymentCloud or on-premise
Compliance
BAA Available Yes AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status Cleared AI-estimated
SOC 2 Yes AI-estimated
Integrations
EHR Not specified
Specialties Cardiology, Radiology

What the Web Says

InVision Precision Cardiac Amyloid is an AI-powered software that analyzes echocardiogram videos to help detect cardiac amyloidosis in adults aged 65 and older. It functions as a diagnostic aid, providing information to clinicians to assist in referring patients for confirmatory investigations. The technology has received FDA 510(k) clearance and Breakthrough Device Designation, and its underlying algorithm was published in JAMA Cardiology.

Overall: Positive

Strengths

  • AI-powered detection of cardiac amyloidosis.
  • Automated analysis of transthoracic echocardiogram videos.
  • Integrates information across multiple standard echocardiographic views for a holistic assessment.
  • High specificity, leading to fewer false positives and erroneous alerts.
  • Integrates with existing hospital imaging systems (PACS).
  • Provides decision support alerts for clinicians.

Limitations

  • Patient management decisions should not be made solely on the results of the device.
  • Indicated for adults aged 65 and over.
  • No reviews found on G2, Capterra, or Reddit.
  • The underlying algorithms are proprietary to the manufacturer.

Based on reviews from: StockTitan, Cardiovascular Business, CMS.gov, invisionmedtech.com, HealthAidB.com, NIH.gov, National Law Review, SOTA2.com, Innolitics.com, Physician AI Tools

Last updated: 2026-10-30

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Press & Coverage

invisionmedtech.com
IMVARIA Labs adopts InVision Precision Cardiac Amyloid
IMVARIA Labs will offer InVision Precision Cardiac Amyloid as a send-out test, making InVision's FDA-cleared amyloid detection available to clinicians on a referral basis without requiring them to run the software within their own imaging systems.
2026-10
invisionmedtech.com
Medicare establishes dedicated reimbursement for InVision's AI detection of cardiac amyloidosis
CMS finalized a New Technology Add-on Payment (NTAP) for InVision Precision Cardiac Amyloid, establishing a defined Medicare payment pathway across inpatient and outpatient settings and making it the only echocardiography technology approved for FY 2027 NTAP.
2026-08
invisionmedtech.com
Partnership with Dandelion Health gives life sciences a new class of cardiac data
InVision's echocardiography AI is now live on Dandelion Health's Clinical AI Marketplace, generating significantly more cardiac measurements per patient from raw imaging data, which is layered onto a decade of longitudinal real-world records.
2026-04
invisionmedtech.com
FDA 510(k) clearance for InVision Precision Cardiac Amyloid
InVision received FDA 510(k) clearance for its AI Software as a Medical Device for detecting cardiac amyloidosis from apical-4-chamber and parasternal-long-axis echo views.
2025-05
invisionmedtech.com
InVision Precision Cardiac Amyloid receives FDA Breakthrough Device Designation
The FDA granted Breakthrough Device Designation to InVision's AI for earlier identification of cardiac amyloidosis, a rare, underdiagnosed, and life-threatening condition.
2024-01
invisionmedtech.com
AMA adopts CPT billing code for Precision Cardiac Amyloid
The American Medical Association adopted a new Category III CPT code (0932T) covering AI adjunctive technologies for evaluating patients with heart failure symptoms, providing a reimbursement pathway for AI-assisted cardiac amyloidosis screening on echocardiography.
2024-07
alnylam.com
Alnylam Pharmaceuticals Collaborates on DETECT-ATTR Study Evaluating InVision Precision Cardiac Amyloid
Alnylam is supporting the DETECT-ATTR study, which evaluates InVision Precision Cardiac Amyloid as an AI-enabled, FDA-cleared, echocardiography-based screening approach for cardiac amyloidosis detection to address underdiagnosis and improve disease recognition.
2026-08
healthaidb.com
InVision Precision Cardiac Amyloid: An AI-driven Software for Early Detection of Cardiac Amyloidosis
InVision Precision Cardiac Amyloid is an AI-driven Software as a Medical Device (SaMD) that analyzes echocardiograms to detect cardiac amyloidosis, aiming to improve early diagnosis and patient outcomes.
2025-10

Videos

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Frequently Asked Questions

InVision Precision Cardiac Amyloid is designed to integrate seamlessly into existing workflows. The software analyzes standard DICOM echocardiogram studies from various vendors like GE, Philips, Siemens, Canon, and handheld POCUS devices. It can be deployed in a hospital's data center or a validated cloud, and the results are typically available very quickly, often before the study ends, appearing as a DICOM secondary capture in the originating study or populating a structured report field or positives worklist.
InVision Precision Cardiac Amyloid has received US FDA 510(k) clearance as an AI Software as a Medical Device (SaMD) for the detection of cardiac amyloidosis. It was also granted FDA Breakthrough Device Designation and enrolled in the FDA's Total Product Lifecycle Advisory Program (TAP). The technology adheres to compliance standards such as IEC 62304, ISO 14971, HIPAA, SOC 2, and ISO 27001.
While InVision Precision Cardiac Amyloid is an FDA-cleared AI diagnostic aid, other approaches exist for detecting cardiac amyloidosis. The predicate device for InVision's amyloid clearance is Ultromics EchoGo Amyloidosis. Traditional diagnostic methods include bone-tracer nuclear imaging, monoclonal gammopathy testing, genetic testing, and tissue biopsy, which are often required for confirmation.
For outpatient studies, the American Medical Association has adopted CPT Category III code 0932T, which became effective January 1, 2025. For inpatient stays, CMS has approved a Medicare New Technology Add-on Payment (NTAP) of up to $2,275 per eligible stay, effective October 1, 2026, which is in addition to the MS-DRG. Coverage and payment ultimately depend on the applicable payer's requirements.
InVision Precision Cardiac Amyloid is an adjunctive diagnostic aid and does not provide a definitive diagnosis; confirmation requires further testing. Its sensitivity at the cleared operating point is 60.7%, meaning a negative result does not exclude cardiac amyloidosis. The intended population is adults aged 65 and older. The validation studies were retrospective case-control studies, and the prevalence was artificially set in some studies, which can impact absolute predictive values.

Compare InVision Precision Cardiac Amyloid

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InVision Precision Cardiac Amyloid vs EchoNext
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Both tools leverage AI for cardiac disease detection, but they differ in their primary diagnostic input and specific focus. InVision Precision Cardiac Amyloid specializes in analyzing echocardiograms for…
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Tool A, InVision Precision Cardiac Amyloid, is an AI-powered software designed to detect cardiac amyloidosis from echocardiography studies. Tool B, MAGNETOM Cima.X, is a 3T MRI system that…
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Tool A, InVision Precision Cardiac Amyloid, is a specialized AI-powered software designed specifically for detecting cardiac amyloidosis from echocardiography. Tool B, the Samsung V7 Diagnostic Ultrasound System, is…
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InVision Precision Cardiac Amyloid vs uPMR 790
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InVision Precision Cardiac Amyloid is an AI-powered software designed to detect cardiac amyloidosis from echocardiogram videos, acting as a diagnostic aid to improve early detection. The uPMR 790,…

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Suggest an Edit → | Report an issue | Last Verified: 2026-04-18 | First Added: 2026-04-18
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