BrainSee

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

Company Name

Darmiyan

Product URL

https://darmiyan.com/products/

Company URL

https://darmiyan.com

Categories

• diagnostic Support
• clinical Care
• patient Facing
• Diagnostic
• Clinical

Summary

BrainSee is an FDA-approved AI-powered software that predicts the likelihood of progression from amnestic mild cognitive impairment to Alzheimer's dementia within five years.

Description

BrainSee integrates brain MRI scans with cognitive test scores to generate a prognostic score, assisting physicians in evaluating the risk of Alzheimer's progression in patients with amnestic mild cognitive impairment (aMCI).

Api Available

unknown

Certifications

• FDA 510(k)
• CE/MDR
• ONC
• ISO 13485
• ISO 14971

Company Founding

2016

Company Offices

• United States

Compliance

• HIPAA
• GDPR
• HITECH
• SOC 2
• ISO 27001

Customers

Data Residency

US/EU regions

Data Standards

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

Deployment Model

• SaaS

Features

• Clinical test for predicting risk of progression to clinical Alzheimer's disease
• Post-market surveillance study
• FDA-approved device

Id

SW0270

Integration Partners

Integrations

• FDA 510(k) approval

Languages Supported

• English

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• consumer

Optional Modules

Os Platforms

• Web

Pricing Details

Contact vendor for pricing information.

Pricing Model

subscription

Privacy Features

• BAA available
• consent mgmt
• anonymization
• data minimization

Product Code

SW0270

Product Name

BrainSee

Ratings

Regions Available

• United States

Related Urls

• https://www.prnewswire.com/news-releases/darmiyan-receives-fda-approval-for-post-market-surveillance-study-of-brainsee-the-first-in-class-clinical-test-for-predicting-risk-of-progression-to-clinical-alzheimers-disease-302468072.html
• https://www.mcra.com/news-publications/case-studies/mcra-supports-darmiyan-fda-approval-brainsee-device
• https://openminds.com/market-intelligence/bulletins/darmiyan-launches-brainsee-platform-for-alzheimers-testing-risk-monitoring/
• 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

• Neurology
• Geriatrics
• Psychiatry

Support Channels

System Requirements

Target Users

• clinicians
• patients

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "BrainSee",
  "company_name": "Darmiyan",
  "product_url": "https://darmiyan.com/products/",
  "company_url": "https://darmiyan.com",
  "related_urls": [
    "https://www.prnewswire.com/news-releases/darmiyan-receives-fda-approval-for-post-market-surveillance-study-of-brainsee-the-first-in-class-clinical-test-for-predicting-risk-of-progression-to-clinical-alzheimers-disease-302468072.html",
    "https://www.mcra.com/news-publications/case-studies/mcra-supports-darmiyan-fda-approval-brainsee-device",
    "https://openminds.com/market-intelligence/bulletins/darmiyan-launches-brainsee-platform-for-alzheimers-testing-risk-monitoring/",
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0270",
  "summary": "BrainSee is an FDA-approved AI-powered software that predicts the likelihood of progression from amnestic mild cognitive impairment to Alzheimer's dementia within five years.",
  "description": "BrainSee integrates brain MRI scans with cognitive test scores to generate a prognostic score, assisting physicians in evaluating the risk of Alzheimer's progression in patients with amnestic mild cognitive impairment (aMCI).",
  "categories": [
    "diagnostic Support",
    "clinical Care",
    "patient Facing",
    "Diagnostic",
    "Clinical",
    "Patient-facing"
  ],
  "market_segment": [
    "enterprise",
    "consumer"
  ],
  "target_users": [
    "clinicians",
    "patients"
  ],
  "specialties": [
    "Neurology",
    "Geriatrics",
    "Psychiatry"
  ],
  "regions_available": [
    "United States"
  ],
  "languages_supported": [
    "English"
  ],
  "pricing_model": "subscription",
  "pricing_details": "Contact vendor for pricing information.",
  "license": "commercial",
  "company_offices": [
    "United States"
  ],
  "company_founding": "2016",
  "deployment_model": [
    "SaaS"
  ],
  "os_platforms": [
    "Web"
  ],
  "features": [
    "Clinical test for predicting risk of progression to clinical Alzheimer's disease",
    "Post-market surveillance study",
    "FDA-approved device"
  ],
  "optional_modules": [],
  "integrations": [
    "FDA 510(k) approval"
  ],
  "data_standards": [
    "FHIR",
    "HL7 v2",
    "DICOM",
    "SNOMED",
    "ICD-10"
  ],
  "api_available": "unknown",
  "system_requirements": "",
  "compliance": [
    "HIPAA",
    "GDPR",
    "HITECH",
    "SOC 2",
    "ISO 27001"
  ],
  "certifications": [
    "FDA 510(k)",
    "CE/MDR",
    "ONC",
    "ISO 13485",
    "ISO 14971"
  ],
  "security_features": [
    "Encryption",
    "RBAC",
    "SSO/SAML",
    "audit logs",
    "2FA",
    "DLP"
  ],
  "privacy_features": [
    "BAA available",
    "consent mgmt",
    "anonymization",
    "data minimization"
  ],
  "data_residency": "US/EU regions",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0270",
  "slug": "brainsee",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/brainsee.json"
  }
}