Unfold AI

JSON twin: https://www.healthaidb.com/software/unfold-ai.json

Company Name

Avenda Health

Product URL

https://avendahealth.com/unfold-ai-based-decision-support/

Company URL

https://avendahealth.com

Categories

• clinical Care
• diagnostic Support
• clinical Decision Support
• oncology Care
• Clinical
• Diagnostic
• Decision Support
• Oncology
• Urology

Summary

Unfold AI is an FDA-cleared AI platform developed by Avenda Health that creates personalized 3D cancer maps to assist physicians in precise prostate cancer treatment planning.

Description

Unfold AI integrates patient-specific data from imaging, biopsies, and pathology to generate detailed 3D cancer estimation maps, enhancing the accuracy of prostate cancer diagnosis and treatment decisions. It has been validated in multiple clinical studies, demonstrating improved tumor detection sensitivity and better prediction of focal therapy success compared to conventional methods. The platform has been integrated with technologies like PrecisionPoint® and Focal One® to further refine treatment approaches. In November 2023, Unfold AI received a Category III CPT code, facilitating its adoption in clinical settings. As of August 2023, the platform is SOC 2 compliant, ensuring high standards of data security and privacy. Unfold AI is currently available in the United States, with plans for broader international expansion. It supports English and is accessible through a subscription-based pricing model, with specific pricing details available upon request. The company, Avenda Health, was founded in 2020 and has offices in the United States.

Api Available

unknown

Certifications

• FDA 510(k) clearance
• SOC 2 compliance

Company Founding

2020

Company Offices

• United States

Compliance

• HIPAA
• GDPR
• SOC 2
• FDA 510(k) clearance

Customers

Data Residency

US-only

Data Standards

• HL7 FHIR
• DICOM

Deployment Model

• SaaS
• on_prem

Features

• 3D AI-generated cancer estimation maps
• Integration of patient-specific data from imaging, biopsies, and pathology
• Deep learning algorithms for tumor localization
• Treatment decision support
• Interventional planning guidance
• Clinical validation studies
• FDA 510(k) clearance
• SOC 2 compliance

Id

SW0396

Integration Partners

Integrations

• Electronic Health Record (EHR) systems
• FocalPoint soft tissue laser ablation device

Languages Supported

• English

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• smb

Optional Modules

• FocalPoint soft tissue laser ablation device integration

Os Platforms

• Web

Pricing Details

contact vendor

Pricing Model

subscription

Privacy Features

• Data anonymization
• Data minimization
• Consent management

Product Code

SW0396

Product Name

Unfold AI

Ratings

Regions Available

• United States

Related Urls

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

Release Year

"2022"

Security Features

• Data encryption at rest and in transit
• Role-based access control
• Audit logging
• Secure API integrations

Specialties

• Urology
• Oncology
• Radiology

Support Channels

System Requirements

Major OS/DB/hardware needs, or empty if SaaS-only

Target Users

• clinicians
• urologists
• oncologists
• radiologists

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

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  "product_name": "Unfold AI",
  "company_name": "Avenda Health",
  "product_url": "https://avendahealth.com/unfold-ai-based-decision-support/",
  "company_url": "https://avendahealth.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0396",
  "summary": "Unfold AI is an FDA-cleared AI platform developed by Avenda Health that creates personalized 3D cancer maps to assist physicians in precise prostate cancer treatment planning.",
  "description": "Unfold AI integrates patient-specific data from imaging, biopsies, and pathology to generate detailed 3D cancer estimation maps, enhancing the accuracy of prostate cancer diagnosis and treatment decisions. It has been validated in multiple clinical studies, demonstrating improved tumor detection sensitivity and better prediction of focal therapy success compared to conventional methods. The platform has been integrated with technologies like PrecisionPoint® and Focal One® to further refine treatment approaches. In November 2023, Unfold AI received a Category III CPT code, facilitating its adoption in clinical settings. As of August 2023, the platform is SOC 2 compliant, ensuring high standards of data security and privacy. Unfold AI is currently available in the United States, with plans for broader international expansion. It supports English and is accessible through a subscription-based pricing model, with specific pricing details available upon request. The company, Avenda Health, was founded in 2020 and has offices in the United States.",
  "categories": [
    "clinical Care",
    "diagnostic Support",
    "clinical Decision Support",
    "oncology Care",
    "Clinical",
    "Diagnostic",
    "Decision Support",
    "Oncology",
    "Urology"
  ],
  "market_segment": [
    "enterprise",
    "smb"
  ],
  "target_users": [
    "clinicians",
    "urologists",
    "oncologists",
    "radiologists"
  ],
  "specialties": [
    "Urology",
    "Oncology",
    "Radiology"
  ],
  "regions_available": [
    "United States"
  ],
  "languages_supported": [
    "English"
  ],
  "pricing_model": "subscription",
  "pricing_details": "contact vendor",
  "license": "commercial",
  "company_offices": [
    "United States"
  ],
  "company_founding": "2020",
  "deployment_model": [
    "SaaS",
    "on_prem"
  ],
  "os_platforms": [
    "Web"
  ],
  "features": [
    "3D AI-generated cancer estimation maps",
    "Integration of patient-specific data from imaging, biopsies, and pathology",
    "Deep learning algorithms for tumor localization",
    "Treatment decision support",
    "Interventional planning guidance",
    "Clinical validation studies",
    "FDA 510(k) clearance",
    "SOC 2 compliance"
  ],
  "optional_modules": [
    "FocalPoint soft tissue laser ablation device integration"
  ],
  "integrations": [
    "Electronic Health Record (EHR) systems",
    "FocalPoint soft tissue laser ablation device"
  ],
  "data_standards": [
    "HL7 FHIR",
    "DICOM"
  ],
  "api_available": "unknown",
  "system_requirements": "Major OS/DB/hardware needs, or empty if SaaS-only",
  "compliance": [
    "HIPAA",
    "GDPR",
    "SOC 2",
    "FDA 510(k) clearance"
  ],
  "certifications": [
    "FDA 510(k) clearance",
    "SOC 2 compliance"
  ],
  "security_features": [
    "Data encryption at rest and in transit",
    "Role-based access control",
    "Audit logging",
    "Secure API integrations"
  ],
  "privacy_features": [
    "Data anonymization",
    "Data minimization",
    "Consent management"
  ],
  "data_residency": "US-only",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "\"2022\"",
  "integration_partners": [],
  "id": "SW0396",
  "slug": "unfold-ai",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/unfold-ai.json"
  }
}