BrainInsight

JSON twin: https://www.healthaidb.com/software/braininsight.json

Company Name

Hyperfine

Product URL

https://hyperfinemri.com

Company URL

https://hyperfinemri.com

Categories

• clinical Care
• diagnostic Support
• imaging Software
• software Development
• Clinical
• Diagnostic
• Imaging
• Software

Summary

BrainInsight is an AI-powered software developed by Hyperfine that enhances MRI imaging by automating post-processing tasks, including labeling, spatial measurement, and volumetric quantification of brain structures, thereby improving diagnostic efficiency and accuracy.

Description

BrainInsight is a fully automated MRI post-processing software developed by Hyperfine, Inc. It is classified by the FDA as a Class II medical device and received 510(k) marketing clearance in January 2021. The software is designed for automatic labeling, spatial measurement, and volumetric quantification of brain structures from low-field MR images, providing annotated and segmented images, color overlays, and reports. In December 2022, Hyperfine received clearance to include pediatric patients aged two years and older for lateral ventricles and midline shift applications. Additionally, in December 2022, Hyperfine received clearance for modifications to the MRI system, including software modifications related to device pulse sequences and retraining of advanced reconstruction models.

Api Available

unknown

Certifications

• FDA 510(k)
• CE/MDR
• ISO 27001
• SOC 2
• GDPR

Company Founding

2014

Company Offices

• United States
• United Kingdom
• Australia
• New Zealand
• Pakistan

Compliance

• HIPAA
• FDA 510(k)
• ISO 27001
• SOC 2
• GDPR

Customers

Data Residency

US/EU regions

Data Standards

• DICOM
• HL7
• FHIR

Deployment Model

• SaaS
• on_prem
• hybrid

Features

• AI-powered portable brain MRI
• Diagnostic-quality imaging
• Rapid setup and operation
• Open design for patient comfort
• No ionizing radiation exposure
• FDA-cleared for pediatric patients aged two years and older
• Automatic labeling of brain structures
• Spatial measurement and volumetric quantification
• Annotated and segmented images
• Color overlays and reports

Id

SW0393

Integration Partners

Integrations

• Swoop® system
• Optive AI™ software

Languages Supported

• English

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• smb

Optional Modules

• Advanced reconstruction models
• Pediatric imaging applications

Os Platforms

• Web
• iOS
• Android
• Windows
• macOS
• Linux

Pricing Details

contact vendor

Pricing Model

subscription

Privacy Features

• BAA available
• Consent management
• Anonymization
• Data minimization

Product Code

SW0393

Product Name

BrainInsight

Ratings

Regions Available

• United States
• Canada
• European Union
• United Kingdom
• Australia
• New Zealand
• Pakistan

Related Urls

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

Release Year

Security Features

• End-to-end encryption
• Role-based access control
• Audit logs
• 2FA
• Data loss prevention

Specialties

• Neurology
• Neurosurgery
• Pediatrics
• Radiology

Support Channels

System Requirements

N/A

Target Users

• clinicians
• radiologists
• neurologists
• neurosurgeons
• pediatricians

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "BrainInsight",
  "company_name": "Hyperfine",
  "product_url": "https://hyperfinemri.com",
  "company_url": "https://hyperfinemri.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0393",
  "summary": "BrainInsight is an AI-powered software developed by Hyperfine that enhances MRI imaging by automating post-processing tasks, including labeling, spatial measurement, and volumetric quantification of brain structures, thereby improving diagnostic efficiency and accuracy.",
  "description": "BrainInsight is a fully automated MRI post-processing software developed by Hyperfine, Inc. It is classified by the FDA as a Class II medical device and received 510(k) marketing clearance in January 2021. The software is designed for automatic labeling, spatial measurement, and volumetric quantification of brain structures from low-field MR images, providing annotated and segmented images, color overlays, and reports. In December 2022, Hyperfine received clearance to include pediatric patients aged two years and older for lateral ventricles and midline shift applications. Additionally, in December 2022, Hyperfine received clearance for modifications to the MRI system, including software modifications related to device pulse sequences and retraining of advanced reconstruction models.",
  "categories": [
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    "imaging Software",
    "software Development",
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    "Software"
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  "market_segment": [
    "enterprise",
    "smb"
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  "target_users": [
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    "radiologists",
    "neurologists",
    "neurosurgeons",
    "pediatricians"
  ],
  "specialties": [
    "Neurology",
    "Neurosurgery",
    "Pediatrics",
    "Radiology"
  ],
  "regions_available": [
    "United States",
    "Canada",
    "European Union",
    "United Kingdom",
    "Australia",
    "New Zealand",
    "Pakistan"
  ],
  "languages_supported": [
    "English"
  ],
  "pricing_model": "subscription",
  "pricing_details": "contact vendor",
  "license": "commercial",
  "company_offices": [
    "United States",
    "United Kingdom",
    "Australia",
    "New Zealand",
    "Pakistan"
  ],
  "company_founding": "2014",
  "deployment_model": [
    "SaaS",
    "on_prem",
    "hybrid"
  ],
  "os_platforms": [
    "Web",
    "iOS",
    "Android",
    "Windows",
    "macOS",
    "Linux"
  ],
  "features": [
    "AI-powered portable brain MRI",
    "Diagnostic-quality imaging",
    "Rapid setup and operation",
    "Open design for patient comfort",
    "No ionizing radiation exposure",
    "FDA-cleared for pediatric patients aged two years and older",
    "Automatic labeling of brain structures",
    "Spatial measurement and volumetric quantification",
    "Annotated and segmented images",
    "Color overlays and reports"
  ],
  "optional_modules": [
    "Advanced reconstruction models",
    "Pediatric imaging applications"
  ],
  "integrations": [
    "Swoop® system",
    "Optive AI™ software"
  ],
  "data_standards": [
    "DICOM",
    "HL7",
    "FHIR"
  ],
  "api_available": "unknown",
  "system_requirements": "N/A",
  "compliance": [
    "HIPAA",
    "FDA 510(k)",
    "ISO 27001",
    "SOC 2",
    "GDPR"
  ],
  "certifications": [
    "FDA 510(k)",
    "CE/MDR",
    "ISO 27001",
    "SOC 2",
    "GDPR"
  ],
  "security_features": [
    "End-to-end encryption",
    "Role-based access control",
    "Audit logs",
    "2FA",
    "Data loss prevention"
  ],
  "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": "SW0393",
  "slug": "braininsight",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/braininsight.json"
  }
}