{"product_name":"HealthFLD","company_name":"Nano-X AI","product_url":"https://www.nano-x.ai/healthfld","company_url":"https://www.nano-x.ai","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0257","summary":"HealthFLD is an AI-powered software by Nano-X AI that analyzes CT scans to detect fatty liver disease, aiding clinicians in early diagnosis and management.","description":"HealthFLD utilizes artificial intelligence to provide automated qualitative and quantitative analysis of liver attenuation from routine contrast and non-contrast chest and abdomen CT scans. It measures liver attenuation in Hounsfield Units (HU) and highlights results outside the reference range, assisting clinicians in identifying patients at risk for metabolic dysfunction-associated steatotic liver disease (MASLD). The software is FDA-cleared for use in patients aged 18 to 75. In a 2023 study of nearly 3,000 patients, HealthFLD demonstrated a sensitivity of 77.8% and specificity of 93.2% at less than 80 HU, indicating its effectiveness in detecting moderate hepatic steatosis. HealthFLD integrates seamlessly into existing clinical workflows, enabling early detection and intervention for patients with fatty liver disease. ([auntminnie.com](https://www.auntminnie.com/clinical-news/ct/article/15664046/nanox-gets-fda-nod-for-healthfld-liver-attenuation-software?utm_source=openai))","categories":["clinical Care","diagnostic Support","imaging Software","ai Clinical Documentation Integrity","clinical Decision Support","Clinical","Diagnostic","Imaging","Artificial Intelligence"],"market_segment":["Enterprise","SMB"],"target_users":["Clinicians","Radiologists","Healthcare Providers"],"specialties":["Hepatology","Radiology","Gastroenterology"],"regions_available":["United States"],"languages_supported":["English"],"pricing_model":"Subscription","pricing_details":"Contact vendor for pricing information.","license":"Commercial","company_offices":["Israel","United States"],"company_founding":"2018","deployment_model":["SaaS"],"os_platforms":["Web"],"features":["Automated qualitative and quantitative analysis of liver attenuation from CT scans","Supports routine contrast and non-contrast chest and abdomen CT scans","Designed for patients aged 18 to 75","FDA 510(k) cleared for use in the general population","Assists clinicians in the assessment and analysis of fatty liver"],"optional_modules":[],"integrations":["CT imaging systems"],"data_standards":["DICOM"],"api_available":"unknown","system_requirements":"","compliance":["HIPAA","FDA 510(k) clearance"],"certifications":["FDA 510(k) clearance"],"security_features":["Data encryption in transit and at rest","Role-Based Access Control (RBAC)","Audit logs","Immutable audit logs","Real-time enforcement controls"],"privacy_features":["Patient consent management","Data anonymization","Data minimization"],"data_residency":"US-only","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0257","slug":"healthfld","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/healthfld.json"}}