{"product_name":"HealthPNX","company_name":"Zebra Medical Vision","product_url":"https://www.zebra-med.com/healthpnx","company_url":"https://www.zebra-med.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0558","summary":"HealthPNX is an AI-powered software developed by Zebra Medical Vision to assist radiologists in detecting pneumothorax in chest X-rays, aiming to expedite diagnosis and improve patient outcomes.","description":"HealthPNX analyzes chest X-rays to identify signs of pneumothorax, a condition where air accumulates between the lung and chest wall, potentially leading to lung collapse. The software alerts clinicians to prioritize these cases, reducing triage time and enhancing diagnostic confidence. It integrates seamlessly into existing radiology workflows without modifying original images, providing passive notifications on PACS worklists. HealthPNX received FDA 510(k) clearance in May 2019, marking it as the first AI chest X-ray triage product approved by the FDA. The algorithm was trained on millions of images to identify over 40 common clinical findings, demonstrating high accuracy and reliability. By streamlining the detection process, HealthPNX supports timely intervention and improved patient care.","categories":["clinical Care","diagnostic Support","radiology","ai Clinical Documentation Integrity","clinical Decision Support","imaging Software","Clinical","Diagnostic","Radiology","Artificial Intelligence","Medical Imaging"],"market_segment":["Enterprise","SMB"],"target_users":["Radiologists","Clinicians","Medical Imaging Professionals"],"specialties":["Radiology","Emergency Medicine","Pulmonology"],"regions_available":["United States","Europe","Israel"],"languages_supported":["English","Hebrew"],"pricing_model":"Subscription","pricing_details":"Contact vendor for pricing information.","license":"Commercial","company_offices":["United States","Israel","Europe"],"company_founding":"2014","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web","iOS","Android","Windows","macOS","Linux"],"features":["Patient-level predicted risk profiles","Generative AI chart summarization and query","Population-level dashboards and high-risk lists","Provider and network performance benchmarking","Configurable analytics reports and portals","Digital-twin comparisons for operational insight","Risk-driver identification","Clinical workflow recommendations","Post-discharge follow-up targeting","Optimization services and advisory support"],"optional_modules":["Advisory/optimization services","EHR embedding integration"],"integrations":["Electronic Health Records (EHR systems)"],"data_standards":["FHIR","HL7 v2","DICOM","SNOMED","ICD-10"],"api_available":"unknown","system_requirements":"Web browser","compliance":["HIPAA","SOC 2","HITRUST R2"],"certifications":["HITRUST R2","AICPA SOC 2"],"security_features":["Responsible AI principles","Compliance-aligned security posture"],"privacy_features":["Commitment to delete personal data on opt-out","No sale of personal data to third parties","Limited data sharing only with primary authorized institution"],"data_residency":"United States","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0558","slug":"healthpnx","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/healthpnx.json"}}