ChestView US

JSON twin: https://www.healthaidb.com/software/chestview-us.json

Company Name

Gleamer

Product URL

https://www.gleamer.ai/solutions/fda

Company URL

https://www.gleamer.ai

Categories

• clinical Care
• diagnostic Support
• radiology
• imaging Software
• Clinical
• Diagnostic
• Ai-powered Imaging

Summary

ChestView US is an AI-powered software developed by Gleamer to assist radiologists in detecting multiple chest pathologies on X-rays, enhancing diagnostic accuracy and efficiency.

Description

ChestView US is an FDA-cleared AI software designed to aid radiologists in the detection of various chest pathologies, including pneumothorax, pleural effusion, consolidation, nodules, and mediastinal masses. It integrates seamlessly into existing clinical workflows, providing immediate, automated second reads of chest X-rays to support diagnosis and triage. The software has demonstrated significant improvements in diagnostic sensitivity and reduced reading times, thereby enhancing patient care and workflow efficiency. ChestView US is part of Gleamer's Copilot suite, which also includes BoneView for bone trauma detection and BoneAge for bone age estimation, all holding MDR class IIa CE certification in Europe. The company has received FDA clearance for BoneView, marking its first AI-powered solution certified for detecting bone fractures in the United States. Gleamer's solutions are recognized for their scientific rigor, with publications in top-tier peer-reviewed journals, and have been implemented in over 2,000 institutions across 45 countries, analyzing more than 35 million examinations. The company was founded in 2017 and has offices in France and the United States.

Api Available

yes

Certifications

• CE Class IIa
• FDA 510(k)

Company Founding

2017

Company Offices

• France
• United States

Compliance

• CE Class IIa
• FDA 510(k)
• GDPR

Customers

Data Residency

US and EU deployment options (cloud/region choices)

Data Standards

• DICOM
• HL7 v2
• FHIR
• SNOMED CT
• ICD-10

Deployment Model

• SaaS
• on_prem
• hybrid

Features

• Multi-finding CADe for chest X‑ray
• Detection of pneumothorax, pleural effusion, consolidation, lung nodule, mediastinal mass
• Lesion localization with explainable regions of interest / heatmaps
• Triage and study prioritization / worklist flagging
• Automated alerts/notifications for critical findings
• DICOM ingest and viewer overlay
• Batch processing / concurrent reading aid
• Reporting assistance and structured outputs
• Explainability / visual overlays for clinician interpretation
• Clinical evidence and performance reporting

Id

SW0083

Integration Partners

Integrations

• Aidoc
• Fujifilm
• VIDI
• RMS Medical Devices
• Sectra
• Incepto Medical
• Blackford Analysis
• Konica Minolta
• PACS
• VNA
• RIS
• DICOM viewers / PACS viewer overlays
• Hospital worklists / workflows

Languages Supported

• English
• French
• Spanish
• German
• Italian
• Portuguese
• Dutch
• Russian
• Chinese
• Japanese
• Korean
• Arabic
• Hindi
• Bengali
• Punjabi
• Javanese
• Turkish
• Vietnamese
• Telugu
• Marathi

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• smb

Optional Modules

Os Platforms

• Web
• Windows
• macOS

Pricing Details

contact vendor

Pricing Model

subscription

Privacy Features

• BAA available
• Data anonymization/de-identification options
• Consent management support

Product Code

SW0083

Product Name

ChestView US

Ratings

Regions Available

• United States
• Europe
• Asia
• Africa
• Australia
• South America
• North America
• Middle East
• Oceania
• Caribbean
• Central America
• Southeast Asia
• East Asia
• South Asia
• Sub-Saharan Africa
• North Africa
• Central Asia
• Western Europe
• Eastern Europe
• Northern Europe
• Southern Europe

Related Urls

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

Release Year

Security Features

• Encryption at rest & in transit
• Role-based access control (RBAC)
• SSO/SAML
• Audit logs
• Two-factor authentication (2FA)

Specialties

• Pulmonology
• Thoracic Radiology
• Emergency Medicine
• Oncology

Support Channels

System Requirements

Windows, macOS

Target Users

• radiologists
• clinicians
• healthcare providers

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

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  "product_name": "ChestView US",
  "company_name": "Gleamer",
  "product_url": "https://www.gleamer.ai/solutions/fda",
  "company_url": "https://www.gleamer.ai",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0083",
  "summary": "ChestView US is an AI-powered software developed by Gleamer to assist radiologists in detecting multiple chest pathologies on X-rays, enhancing diagnostic accuracy and efficiency.",
  "description": "ChestView US is an FDA-cleared AI software designed to aid radiologists in the detection of various chest pathologies, including pneumothorax, pleural effusion, consolidation, nodules, and mediastinal masses. It integrates seamlessly into existing clinical workflows, providing immediate, automated second reads of chest X-rays to support diagnosis and triage. The software has demonstrated significant improvements in diagnostic sensitivity and reduced reading times, thereby enhancing patient care and workflow efficiency. ChestView US is part of Gleamer's Copilot suite, which also includes BoneView for bone trauma detection and BoneAge for bone age estimation, all holding MDR class IIa CE certification in Europe. The company has received FDA clearance for BoneView, marking its first AI-powered solution certified for detecting bone fractures in the United States. Gleamer's solutions are recognized for their scientific rigor, with publications in top-tier peer-reviewed journals, and have been implemented in over 2,000 institutions across 45 countries, analyzing more than 35 million examinations. The company was founded in 2017 and has offices in France and the United States.",
  "categories": [
    "clinical Care",
    "diagnostic Support",
    "radiology",
    "imaging Software",
    "Clinical",
    "Diagnostic",
    "Radiology",
    "Ai-powered Imaging"
  ],
  "market_segment": [
    "enterprise",
    "smb"
  ],
  "target_users": [
    "radiologists",
    "clinicians",
    "healthcare providers"
  ],
  "specialties": [
    "Pulmonology",
    "Thoracic Radiology",
    "Emergency Medicine",
    "Oncology"
  ],
  "regions_available": [
    "United States",
    "Europe",
    "Asia",
    "Africa",
    "Australia",
    "South America",
    "North America",
    "Middle East",
    "Oceania",
    "Caribbean",
    "Central America",
    "Southeast Asia",
    "East Asia",
    "South Asia",
    "Sub-Saharan Africa",
    "North Africa",
    "Central Asia",
    "Western Europe",
    "Eastern Europe",
    "Northern Europe",
    "Southern Europe"
  ],
  "languages_supported": [
    "English",
    "French",
    "Spanish",
    "German",
    "Italian",
    "Portuguese",
    "Dutch",
    "Russian",
    "Chinese",
    "Japanese",
    "Korean",
    "Arabic",
    "Hindi",
    "Bengali",
    "Punjabi",
    "Javanese",
    "Turkish",
    "Vietnamese",
    "Telugu",
    "Marathi"
  ],
  "pricing_model": "subscription",
  "pricing_details": "contact vendor",
  "license": "commercial",
  "company_offices": [
    "France",
    "United States"
  ],
  "company_founding": "2017",
  "deployment_model": [
    "SaaS",
    "on_prem",
    "hybrid"
  ],
  "os_platforms": [
    "Web",
    "Windows",
    "macOS"
  ],
  "features": [
    "Multi-finding CADe for chest X‑ray",
    "Detection of pneumothorax, pleural effusion, consolidation, lung nodule, mediastinal mass",
    "Lesion localization with explainable regions of interest / heatmaps",
    "Triage and study prioritization / worklist flagging",
    "Automated alerts/notifications for critical findings",
    "DICOM ingest and viewer overlay",
    "Batch processing / concurrent reading aid",
    "Reporting assistance and structured outputs",
    "Explainability / visual overlays for clinician interpretation",
    "Clinical evidence and performance reporting"
  ],
  "optional_modules": [],
  "integrations": [
    "Aidoc",
    "Fujifilm",
    "VIDI",
    "RMS Medical Devices",
    "Sectra",
    "Incepto Medical",
    "Blackford Analysis",
    "Konica Minolta",
    "PACS",
    "VNA",
    "RIS",
    "DICOM viewers / PACS viewer overlays",
    "Hospital worklists / workflows"
  ],
  "data_standards": [
    "DICOM",
    "HL7 v2",
    "FHIR",
    "SNOMED CT",
    "ICD-10"
  ],
  "api_available": "yes",
  "system_requirements": "Windows, macOS",
  "compliance": [
    "CE Class IIa",
    "FDA 510(k)",
    "GDPR"
  ],
  "certifications": [
    "CE Class IIa",
    "FDA 510(k)"
  ],
  "security_features": [
    "Encryption at rest & in transit",
    "Role-based access control (RBAC)",
    "SSO/SAML",
    "Audit logs",
    "Two-factor authentication (2FA)"
  ],
  "privacy_features": [
    "BAA available",
    "Data anonymization/de-identification options",
    "Consent management support"
  ],
  "data_residency": "US and EU deployment options (cloud/region choices)",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0083",
  "slug": "chestview-us",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/chestview-us.json"
  }
}