{"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"}}