EchoGo Amyloidosis

JSON twin: https://www.healthaidb.com/software/echogo-amyloidosis.json

Company Name

Ultromics

Product URL

https://www.ultromics.com/echogo-amyloidosis

Company URL

https://www.ultromics.com

Categories

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

Summary

EchoGo® Amyloidosis is an AI-driven diagnostic tool that analyzes echocardiograms to identify cardiac amyloidosis, aiding early detection and treatment decisions.

Description

EchoGo® Amyloidosis is an FDA-cleared, AI-based screening tool designed to detect cardiac amyloidosis from standard echocardiogram images. It integrates seamlessly into clinical workflows, analyzing data to identify at-risk patients and generate reports for interpreting physicians. The device has demonstrated high sensitivity and specificity in detecting cardiac amyloidosis, including various subtypes, and is eligible for Medicare reimbursement in both inpatient and outpatient settings.

Api Available

yes

Certifications

• FDA 510(k) clearance
• CE mark
• ISO 27001
• ISO 13485

Company Founding

2017

Company Offices

• United Kingdom
• United States
• Germany
• France
• Italy
• Spain
• Netherlands
• Sweden
• Norway
• Denmark

Compliance

• HIPAA
• GDPR
• UK Data Protection regulations
• ISO 27001
• ISO 13485
• SOC 2 Type II
• CyberEssentials

Customers

Data Residency

UK/EU and US cloud hosting options

Data Standards

• DICOM
• HL7
• FHIR

Deployment Model

• SaaS

Features

• AI-based cardiac amyloidosis detection from echocardiograms
• Automated analysis of single apical 4-chamber echo video clips
• Integration with existing clinical systems via DICOM
• Automated report generation
• Cloud-native architecture for scalability
• Secure cloud VPN connection with data anonymization
• FDA-cleared as a Breakthrough Device
• Reimbursement support with NTAP and HCPCS codes

Id

SW0130

Integration Partners

Integrations

• PACS
• Hospital EHR/EMR systems
• RIS/reporting systems
• DICOM modalities (ultrasound vendors)
• Clinical workflow systems/reporting viewers

Languages Supported

• English
• Spanish
• French
• German
• Italian
• Portuguese
• Dutch
• Swedish
• Norwegian
• Danish
• Finnish
• Polish
• Czech
• Hungarian
• Romanian
• Bulgarian
• Greek
• Turkish
• Russian
• Chinese
• Japanese

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• smb

Optional Modules

Os Platforms

• Web

Pricing Details

Contact vendor for pricing information.

Pricing Model

subscription

Privacy Features

• Data anonymization
• Data residency options in UK/EU and US cloud hosting regions

Product Code

SW0130

Product Name

EchoGo Amyloidosis

Ratings

Regions Available

• United States
• United Kingdom
• Europe
• Canada
• Australia
• New Zealand
• Japan
• South Korea
• Singapore
• Hong Kong
• India
• China
• Brazil
• Mexico
• South Africa
• Saudi Arabia
• United Arab Emirates
• Israel
• Turkey
• Russia

Related Urls

• https://www.prnewswire.com/news-releases/ultromics-granted-fda-breakthrough-device-designation-for-ai-enhanced-cardiac-amyloidosis-detection-301808243.html
• https://www.lightrock.com/portfolio/ultromics/
• https://biotechscope.com/company/ultromics/
• https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices

Release Year

Security Features

• Data encryption in transit and at rest
• Role-based access control (RBAC)
• SSO/SAML support
• Audit logging
• Multi-factor authentication (MFA/2FA)

Specialties

• Cardiology

Support Channels

System Requirements

Modern web browser; cloud-hosted service (no on-prem server required for SaaS use)

Target Users

• clinicians
• cardiologists
• healthcare providers

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "EchoGo Amyloidosis",
  "company_name": "Ultromics",
  "product_url": "https://www.ultromics.com/echogo-amyloidosis",
  "company_url": "https://www.ultromics.com",
  "related_urls": [
    "https://www.prnewswire.com/news-releases/ultromics-granted-fda-breakthrough-device-designation-for-ai-enhanced-cardiac-amyloidosis-detection-301808243.html",
    "https://www.lightrock.com/portfolio/ultromics/",
    "https://biotechscope.com/company/ultromics/",
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0130",
  "summary": "EchoGo® Amyloidosis is an AI-driven diagnostic tool that analyzes echocardiograms to identify cardiac amyloidosis, aiding early detection and treatment decisions.",
  "description": "EchoGo® Amyloidosis is an FDA-cleared, AI-based screening tool designed to detect cardiac amyloidosis from standard echocardiogram images. It integrates seamlessly into clinical workflows, analyzing data to identify at-risk patients and generate reports for interpreting physicians. The device has demonstrated high sensitivity and specificity in detecting cardiac amyloidosis, including various subtypes, and is eligible for Medicare reimbursement in both inpatient and outpatient settings.",
  "categories": [
    "diagnostic Support",
    "clinical Care",
    "cardiology",
    "Diagnostic",
    "Clinical",
    "Cardiology"
  ],
  "market_segment": [
    "enterprise",
    "smb"
  ],
  "target_users": [
    "clinicians",
    "cardiologists",
    "healthcare providers"
  ],
  "specialties": [
    "Cardiology"
  ],
  "regions_available": [
    "United States",
    "United Kingdom",
    "Europe",
    "Canada",
    "Australia",
    "New Zealand",
    "Japan",
    "South Korea",
    "Singapore",
    "Hong Kong",
    "India",
    "China",
    "Brazil",
    "Mexico",
    "South Africa",
    "Saudi Arabia",
    "United Arab Emirates",
    "Israel",
    "Turkey",
    "Russia"
  ],
  "languages_supported": [
    "English",
    "Spanish",
    "French",
    "German",
    "Italian",
    "Portuguese",
    "Dutch",
    "Swedish",
    "Norwegian",
    "Danish",
    "Finnish",
    "Polish",
    "Czech",
    "Hungarian",
    "Romanian",
    "Bulgarian",
    "Greek",
    "Turkish",
    "Russian",
    "Chinese",
    "Japanese"
  ],
  "pricing_model": "subscription",
  "pricing_details": "Contact vendor for pricing information.",
  "license": "commercial",
  "company_offices": [
    "United Kingdom",
    "United States",
    "Germany",
    "France",
    "Italy",
    "Spain",
    "Netherlands",
    "Sweden",
    "Norway",
    "Denmark"
  ],
  "company_founding": "2017",
  "deployment_model": [
    "SaaS"
  ],
  "os_platforms": [
    "Web"
  ],
  "features": [
    "AI-based cardiac amyloidosis detection from echocardiograms",
    "Automated analysis of single apical 4-chamber echo video clips",
    "Integration with existing clinical systems via DICOM",
    "Automated report generation",
    "Cloud-native architecture for scalability",
    "Secure cloud VPN connection with data anonymization",
    "FDA-cleared as a Breakthrough Device",
    "Reimbursement support with NTAP and HCPCS codes"
  ],
  "optional_modules": [],
  "integrations": [
    "PACS",
    "Hospital EHR/EMR systems",
    "RIS/reporting systems",
    "DICOM modalities (ultrasound vendors)",
    "Clinical workflow systems/reporting viewers"
  ],
  "data_standards": [
    "DICOM",
    "HL7",
    "FHIR"
  ],
  "api_available": "yes",
  "system_requirements": "Modern web browser; cloud-hosted service (no on-prem server required for SaaS use)",
  "compliance": [
    "HIPAA",
    "GDPR",
    "UK Data Protection regulations",
    "ISO 27001",
    "ISO 13485",
    "SOC 2 Type II",
    "CyberEssentials"
  ],
  "certifications": [
    "FDA 510(k) clearance",
    "CE mark",
    "ISO 27001",
    "ISO 13485"
  ],
  "security_features": [
    "Data encryption in transit and at rest",
    "Role-based access control (RBAC)",
    "SSO/SAML support",
    "Audit logging",
    "Multi-factor authentication (MFA/2FA)"
  ],
  "privacy_features": [
    "Data anonymization",
    "Data residency options in UK/EU and US cloud hosting regions"
  ],
  "data_residency": "UK/EU and US cloud hosting options",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0130",
  "slug": "echogo-amyloidosis",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/echogo-amyloidosis.json"
  }
}