Viz HCM

JSON twin: https://www.healthaidb.com/software/viz-hcm.json

Company Name

Viz.ai

Product URL

https://www.viz.ai/viz-hypertrophic-cardiomyopathy

Company URL

https://www.viz.ai

Categories

• clinical Care
• diagnostic Support
• patient Facing
• administrative Operations
• Clinical
• Diagnostic
• Administrative

Summary

Viz HCM is an AI-powered software developed by Viz.ai to detect and manage hypertrophic cardiomyopathy (HCM) through real-time analysis of 12-lead ECGs, aiming to expedite diagnosis and improve patient outcomes.

Description

Viz HCM is an artificial intelligence (AI) algorithm designed to analyze 12-lead electrocardiograms (ECGs) to identify suspected cases of hypertrophic cardiomyopathy (HCM). Integrated into the Viz.ai Platform, it notifies cardiologists via a mobile application, facilitating timely review and coordination for further diagnostic testing. This approach aims to reduce the time to diagnosis, which can often span several years, and enhance patient care by ensuring early detection and intervention. The algorithm has been validated using a diverse dataset of over 830,000 ECG exams from 300,000 individuals, encompassing both non-obstructive and obstructive forms of HCM. It has been granted De Novo approval by the U.S. Food and Drug Administration (FDA), establishing a new regulatory category for cardiovascular machine learning-based notification software. Viz HCM is part of the Viz.ai Cardio Suite, which is adopted by nearly 1,300 hospitals in the U.S. and Europe, and is integrated with electronic medical records (EMR) systems such as Epic and Cerner. The platform also includes features like an echocardiogram viewer and HIPAA-compliant communication tools to support comprehensive cardiac care coordination. Additionally, Viz.ai has collaborated with the Hypertrophic Cardiomyopathy Association (HCMA) to advance research and support patients with HCM. The company has been recognized with multiple Edison Awards for its innovation in healthcare technology, including the 2025 award for the Viz HCM module in the Health Medical & Biotech category and Cardiovascular Health Diagnostics and Monitoring subcategory.

Api Available

unknown

Certifications

• FDA De Novo Approval
• FDA 510(k)
• CE/MDR
• ONC
• ISO 27001:2022
• ISO 22301:2019
• ISO 27017:2015
• ISO 27018:2019
• ISO 27032:2012
• ISO 27701:2019
• ISO 27799:2016

Company Founding

2016

Company Offices

• United States
• Europe

Compliance

• HIPAA
• SOC 2 Type II
• ISO 27001:2022
• ISO 22301:2019
• ISO 27017:2015
• ISO 27018:2019
• ISO 27032:2012
• ISO 27701:2019
• ISO 27799:2016

Customers

Data Residency

US/EU regions

Data Standards

• ECG
• HL7
• DICOM

Deployment Model

• SaaS

Features

• AI-powered hypertrophic cardiomyopathy detection
• Automated ECG analysis
• Real-time notifications to cardiologists
• Integration with Viz.ai Cardio Suite
• Mobile-based electrocardiogram viewer
• AI-powered alerts and communication tools
• Clinical validation with echocardiography and cardiac MRIs
• FDA-cleared AI algorithm
• Integration with Viz.ai Platform
• Multi-year agreement with Bristol Myers Squibb

Id

SW0325

Integration Partners

Integrations

• Viz.ai Platform
• Viz.ai Cardio Suite
• Viz Echo Viewer
• Bristol Myers Squibb

Languages Supported

• English

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• smb

Optional Modules

• Viz.ai Cardio Suite
• Viz Echo Viewer

Os Platforms

• Web
• iOS
• Android

Pricing Details

contact vendor

Pricing Model

subscription

Privacy Features

• BAA available
• Consent management
• Anonymization
• Data minimization

Product Code

SW0325

Product Name

Viz HCM

Ratings

Regions Available

• United States
• Europe

Related Urls

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

Release Year

""

Security Features

• Encryption
• RBAC
• SSO/SAML
• Audit logs
• 2FA
• DLP

Specialties

• Cardiology

Support Channels

System Requirements

Target Users

• clinicians
• cardiologists
• patients
• admins

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "Viz HCM",
  "company_name": "Viz.ai",
  "product_url": "https://www.viz.ai/viz-hypertrophic-cardiomyopathy",
  "company_url": "https://www.viz.ai",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0325",
  "summary": "Viz HCM is an AI-powered software developed by Viz.ai to detect and manage hypertrophic cardiomyopathy (HCM) through real-time analysis of 12-lead ECGs, aiming to expedite diagnosis and improve patient outcomes.",
  "description": "Viz HCM is an artificial intelligence (AI) algorithm designed to analyze 12-lead electrocardiograms (ECGs) to identify suspected cases of hypertrophic cardiomyopathy (HCM). Integrated into the Viz.ai Platform, it notifies cardiologists via a mobile application, facilitating timely review and coordination for further diagnostic testing. This approach aims to reduce the time to diagnosis, which can often span several years, and enhance patient care by ensuring early detection and intervention. The algorithm has been validated using a diverse dataset of over 830,000 ECG exams from 300,000 individuals, encompassing both non-obstructive and obstructive forms of HCM. It has been granted De Novo approval by the U.S. Food and Drug Administration (FDA), establishing a new regulatory category for cardiovascular machine learning-based notification software. Viz HCM is part of the Viz.ai Cardio Suite, which is adopted by nearly 1,300 hospitals in the U.S. and Europe, and is integrated with electronic medical records (EMR) systems such as Epic and Cerner. The platform also includes features like an echocardiogram viewer and HIPAA-compliant communication tools to support comprehensive cardiac care coordination. Additionally, Viz.ai has collaborated with the Hypertrophic Cardiomyopathy Association (HCMA) to advance research and support patients with HCM. The company has been recognized with multiple Edison Awards for its innovation in healthcare technology, including the 2025 award for the Viz HCM module in the Health Medical & Biotech category and Cardiovascular Health Diagnostics and Monitoring subcategory.",
  "categories": [
    "clinical Care",
    "diagnostic Support",
    "patient Facing",
    "administrative Operations",
    "Clinical",
    "Diagnostic",
    "Patient-facing",
    "Administrative"
  ],
  "market_segment": [
    "enterprise",
    "smb"
  ],
  "target_users": [
    "clinicians",
    "cardiologists",
    "patients",
    "admins"
  ],
  "specialties": [
    "Cardiology"
  ],
  "regions_available": [
    "United States",
    "Europe"
  ],
  "languages_supported": [
    "English"
  ],
  "pricing_model": "subscription",
  "pricing_details": "contact vendor",
  "license": "commercial",
  "company_offices": [
    "United States",
    "Europe"
  ],
  "company_founding": "2016",
  "deployment_model": [
    "SaaS"
  ],
  "os_platforms": [
    "Web",
    "iOS",
    "Android"
  ],
  "features": [
    "AI-powered hypertrophic cardiomyopathy detection",
    "Automated ECG analysis",
    "Real-time notifications to cardiologists",
    "Integration with Viz.ai Cardio Suite",
    "Mobile-based electrocardiogram viewer",
    "AI-powered alerts and communication tools",
    "Clinical validation with echocardiography and cardiac MRIs",
    "FDA-cleared AI algorithm",
    "Integration with Viz.ai Platform",
    "Multi-year agreement with Bristol Myers Squibb"
  ],
  "optional_modules": [
    "Viz.ai Cardio Suite",
    "Viz Echo Viewer"
  ],
  "integrations": [
    "Viz.ai Platform",
    "Viz.ai Cardio Suite",
    "Viz Echo Viewer",
    "Bristol Myers Squibb"
  ],
  "data_standards": [
    "ECG",
    "HL7",
    "DICOM"
  ],
  "api_available": "unknown",
  "system_requirements": "",
  "compliance": [
    "HIPAA",
    "SOC 2 Type II",
    "ISO 27001:2022",
    "ISO 22301:2019",
    "ISO 27017:2015",
    "ISO 27018:2019",
    "ISO 27032:2012",
    "ISO 27701:2019",
    "ISO 27799:2016"
  ],
  "certifications": [
    "FDA De Novo Approval",
    "FDA 510(k)",
    "CE/MDR",
    "ONC",
    "ISO 27001:2022",
    "ISO 22301:2019",
    "ISO 27017:2015",
    "ISO 27018:2019",
    "ISO 27032:2012",
    "ISO 27701:2019",
    "ISO 27799:2016"
  ],
  "security_features": [
    "Encryption",
    "RBAC",
    "SSO/SAML",
    "Audit logs",
    "2FA",
    "DLP"
  ],
  "privacy_features": [
    "BAA available",
    "Consent management",
    "Anonymization",
    "Data minimization"
  ],
  "data_residency": "US/EU regions",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "\"\"",
  "integration_partners": [],
  "id": "SW0325",
  "slug": "viz-hcm",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/viz-hcm.json"
  }
}