{"product_name":"Exo Iris","company_name":"Exo","product_url":"https://www.exo.inc/ai","company_url":"https://www.exo.inc/","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0126","summary":"Exo Iris is a handheld ultrasound device that combines high-performance imaging with real-time AI, enabling clinicians to perform point-of-care diagnostics efficiently and accurately.","description":"Exo Iris is a portable ultrasound device designed to provide instant imaging and AI-driven insights at the point of care. It features a 150° ultra-wide field of view, allowing visualization of entire organs, and can image up to 30 cm deep. The device includes SweepAI™, an on-device AI that automates the capture of cardiac and lung views and quantifies conditions such as heart failure and ventricular hypertrophy in seconds. Exo Iris integrates seamlessly with healthcare IT systems, supporting DICOM, PACS, and Vendor-Neutral Archive (VNA) for image storage and sharing. It is built for durability with an IP67 waterproof rating and a 1-meter drop test certification. The device is available in three packages: Iris Essential, Iris Connect, and Iris Enterprise, each offering varying levels of features and integration capabilities.","categories":["diagnostic Support","clinical Care","patient Facing","administrative Operations","Diagnostic","Clinical","Patient-facing","Administrative"],"market_segment":["enterprise","smb","consumer"],"target_users":["clinicians","nurses","patients","admins"],"specialties":["Cardiology","Pulmonology","Emergency Medicine","Critical Care","Obstetrics","Gynecology","Urology","Orthopedics","Rheumatology","Gastroenterology","Nephrology","Neurology","Endocrinology","Oncology","Pediatrics","Geriatrics","Sports Medicine","Infectious Disease","Internal Medicine","Family Medicine"],"regions_available":["United States","Canada","European Union","United Kingdom","Australia","New Zealand","Japan","South Korea","China","India","Brazil","Mexico","South Africa","Saudi Arabia","United Arab Emirates","Singapore","Malaysia","Thailand","Indonesia","Philippines"],"languages_supported":["English","Spanish","French","German","Italian","Portuguese","Dutch","Russian","Chinese","Japanese","Korean","Arabic","Hindi","Bengali","Punjabi","Telugu","Marathi","Tamil","Urdu","Gujarati"],"pricing_model":"subscription","pricing_details":"Iris Essential: $4,999; Iris Connect and Iris Enterprise: contact vendor for pricing","license":"commercial","company_offices":["United States","Canada","United Kingdom","Germany","France","India","China","Japan","South Korea","Australia"],"company_founding":"2019","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web","iOS","Android"],"features":["Vendor-neutral EHR integration","Image storage via DICOM or local network","Mobile connectivity with multi-factor authentication","Secure login with Face ID, Touch ID, or pin code","Anonymization of protected health information (PHI)","Seamless image transfer to PACS and EHR systems","AI-powered quality assessment with SweepAI","FDA-cleared AI indicators for cardiac and lung conditions","Automated AI-based education through Exo U"],"optional_modules":["Exo Works cloud integration","Enterprise package for expanded connectivity"],"integrations":["PACS","EHR systems","Exo Works cloud"],"data_standards":["DICOM","HL7","FHIR"],"api_available":"yes","system_requirements":["iOS 12.0 or later","Android 8.0 or later","Web browser with HTML5 support"],"compliance":["HIPAA","ISO 27001:2022","SOC 2","GDPR"],"certifications":["FDA 510(k) clearance","CE Marking","ISO 13485","ISO 9001"],"security_features":["End-to-end encryption","Multi-factor authentication","Role-based access control (RBAC)","Audit logs","Secure data transmission (TLS 1.3)","Data anonymization"],"privacy_features":["Business Associate Agreement (BAA)","Data minimization","Consent management","Anonymization of PHI"],"data_residency":"US and EU regions","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0126","slug":"exo-iris","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/exo-iris.json"}}