InVision Precision Cardiac Amyloid

JSON twin: https://www.healthaidb.com/software/invision-precision-cardiac-amyloid.json

Company Name

InVision Medical Technology Corporation

Product URL

https://invisionmedical.com

Company URL

https://invisionmedical.com

Categories

• diagnostic Support
• clinical Care
• cardiology
• Diagnostic
• Clinical

Summary

InVision Precision Cardiac Amyloid is an AI-driven software that analyzes echocardiograms to detect cardiac amyloidosis, aiming to improve early diagnosis and patient outcomes.

Description

InVision Precision Cardiac Amyloid is a Software as a Medical Device (SaMD) developed by InVision Medical Technology Corporation. It utilizes machine learning algorithms to analyze transthoracic echocardiogram videos, specifically apical-4-chamber and parasternal-long-axis views, to identify signs of cardiac amyloidosis in patients aged 65 and older. The software integrates with existing hospital imaging systems, providing decision support alerts to guide clinicians in referring patients for further confirmatory tests. It received FDA 510(k) clearance on May 21, 2025, and was granted Breakthrough Device Designation by the FDA in January 2024. Additionally, the American Medical Association adopted a new Category III CPT code (0932T) for this technology, effective January 1, 2025.

Api Available

unknown

Certifications

• FDA 510(k) clearance
• FDA Breakthrough Device Designation
• CPT code 0932T
• IEC 62304
• ISO 14971
• ISO 27001

Company Founding

2020

Company Offices

• United States

Compliance

• FDA 510(k) clearance
• FDA Breakthrough Device Designation
• IEC 62304
• ISO 14971
• HIPAA
• SOC 2
• ISO 27001

Customers

Data Residency

Hosted platforms

Data Standards

• DICOM

Deployment Model

• SaaS

Features

• AI-powered detection of cardiac amyloidosis
• Automated analysis of transthoracic echocardiogram videos
• Integration with existing hospital imaging systems
• Decision support alerts for clinicians
• FDA 510(k) clearance
• FDA Breakthrough Device Designation
• Published in JAMA Cardiology
• CPT code 0932T for billing
• Collaboration with Alexion to improve detection
• Clinical validation on 1,221 echocardiogram studies
• Sensitivity of 60.7% and specificity of 99.0%
• Compatible with DICOM imaging standards
• Supports adult patients aged 65 and over
• Intended for use by interpreting physicians
• Operates on hosted platforms
• Complies with IEC 62304 software standards
• Complies with ISO 14971 risk management
• Cybersecurity testing confirmed no vulnerabilities
• No physical form; installed as a third-party application
• Assists in diagnosis of cardiac amyloidosis

Id

SW0016

Integration Partners

Integrations

• PACS systems

Languages Supported

• English

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• consumer

Optional Modules

Os Platforms

• Web

Pricing Details

contact vendor

Pricing Model

subscription

Privacy Features

• Complies with HIPAA
• Complies with ISO 27001

Product Code

SW0016

Product Name

InVision Precision Cardiac Amyloid

Ratings

Regions Available

• United States

Related Urls

• https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices

Release Year

Security Features

• Cybersecurity testing confirmed no vulnerabilities

Specialties

• Cardiology

Support Channels

System Requirements

Compatible with DICOM-compliant imaging devices and PACS systems

Target Users

• clinicians
• patients

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

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  "company_name": "InVision Medical Technology Corporation",
  "product_url": "https://invisionmedical.com",
  "company_url": "https://invisionmedical.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
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  "product_code": "SW0016",
  "summary": "InVision Precision Cardiac Amyloid is an AI-driven software that analyzes echocardiograms to detect cardiac amyloidosis, aiming to improve early diagnosis and patient outcomes.",
  "description": "InVision Precision Cardiac Amyloid is a Software as a Medical Device (SaMD) developed by InVision Medical Technology Corporation. It utilizes machine learning algorithms to analyze transthoracic echocardiogram videos, specifically apical-4-chamber and parasternal-long-axis views, to identify signs of cardiac amyloidosis in patients aged 65 and older. The software integrates with existing hospital imaging systems, providing decision support alerts to guide clinicians in referring patients for further confirmatory tests. It received FDA 510(k) clearance on May 21, 2025, and was granted Breakthrough Device Designation by the FDA in January 2024. Additionally, the American Medical Association adopted a new Category III CPT code (0932T) for this technology, effective January 1, 2025.",
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  "target_users": [
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  "specialties": [
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  "regions_available": [
    "United States"
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  "languages_supported": [
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  "pricing_model": "subscription",
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  "license": "commercial",
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  "deployment_model": [
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  "features": [
    "AI-powered detection of cardiac amyloidosis",
    "Automated analysis of transthoracic echocardiogram videos",
    "Integration with existing hospital imaging systems",
    "Decision support alerts for clinicians",
    "FDA 510(k) clearance",
    "FDA Breakthrough Device Designation",
    "Published in JAMA Cardiology",
    "CPT code 0932T for billing",
    "Collaboration with Alexion to improve detection",
    "Clinical validation on 1,221 echocardiogram studies",
    "Sensitivity of 60.7% and specificity of 99.0%",
    "Compatible with DICOM imaging standards",
    "Supports adult patients aged 65 and over",
    "Intended for use by interpreting physicians",
    "Operates on hosted platforms",
    "Complies with IEC 62304 software standards",
    "Complies with ISO 14971 risk management",
    "Cybersecurity testing confirmed no vulnerabilities",
    "No physical form; installed as a third-party application",
    "Assists in diagnosis of cardiac amyloidosis"
  ],
  "optional_modules": [],
  "integrations": [
    "PACS systems"
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  "data_standards": [
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  "api_available": "unknown",
  "system_requirements": "Compatible with DICOM-compliant imaging devices and PACS systems",
  "compliance": [
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    "ISO 14971",
    "ISO 27001"
  ],
  "security_features": [
    "Cybersecurity testing confirmed no vulnerabilities"
  ],
  "privacy_features": [
    "Complies with HIPAA",
    "Complies with ISO 27001"
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  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0016",
  "slug": "invision-precision-cardiac-amyloid",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
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