{"product_name":"CADDIE","company_name":"Odin Medical","product_url":"https://odin-vision.com/en_gb/product/","company_url":"https://odin-vision.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0192","summary":"CADDIE is a cloud-based AI system developed by Odin Medical to assist gastroenterologists in detecting and characterizing colorectal polyps during colonoscopy procedures, enhancing early detection of colorectal cancer.","description":"CADDIE is a cloud-based AI system developed by Odin Medical to assist gastroenterologists in detecting and characterizing colorectal polyps during colonoscopy procedures, enhancing early detection of colorectal cancer. It analyzes colonoscopy video in real-time, providing visual markers to alert endoscopists to potential polyps, which they can then review and confirm based on their medical judgment. The system integrates with Olympus' EVIS X1 and EVIS EXERA III endoscopy systems, offering seamless adoption into clinical practice. CADDIE received FDA 510(k) clearance in September 2024 and CE marking in October 2024, indicating its regulatory approval in the U.S. and Europe. A multi-center randomized controlled trial demonstrated its efficacy, showing significant increases in detection rates for various lesion types without increasing procedural risks or duration. The system is designed to be user-friendly, requiring minimal training and allowing hands-free interaction during procedures. It is intended to complement, not replace, comprehensive patient evaluations and is limited to use with standard white-light endoscopy imaging only.","categories":["clinical Care","diagnostic Support","patient Facing","ai Clinical Documentation Integrity","clinical Decision Support","imaging Software","cloud-based Solutions","medical Device","regulatory Compliance","healthcare Technology","Clinical","Diagnostic","Patient-facing","Artificial Intelligence","Endoscopy","Medical Imaging","Cloud Computing","Medical Device","Regulatory Compliance","Healthcare Technology"],"market_segment":["Enterprise","SMB"],"target_users":["Clinicians","Gastroenterologists","Endoscopists","Medical Professionals"],"specialties":["Gastroenterology","Colorectal Surgery","Oncology","Endoscopy","Medical Imaging","Artificial Intelligence In Healthcare","Medical Device Technology","Cloud Computing In Healthcare","Regulatory Affairs In Medical Devices","Healthcare It"],"regions_available":["United States","Europe","Asia","Australia","Canada","South America","Africa","Middle East","Oceania","New Zealand"],"languages_supported":["English","Spanish","French","German","Italian","Portuguese","Dutch","Swedish","Norwegian","Danish","Finnish","Polish","Russian","Chinese","Japanese","Korean","Arabic","Hindi","Bengali","Punjabi"],"pricing_model":"Subscription","pricing_details":"Contact vendor for pricing information.","license":"Commercial","company_offices":["United States","United Kingdom","Germany","France","Italy","Spain","Netherlands","Sweden","Norway","Denmark"],"company_founding":"2018","deployment_model":["cloud"],"os_platforms":["Web"],"features":["Real-time colonoscopy video analysis","AI-driven detection of colorectal polyps","Visual markers for suspected polyp locations","Cloud-based software with remote updates","Integration with standard white-light endoscopy systems"],"optional_modules":[],"integrations":["standard white-light endoscopy systems"],"data_standards":["HL7 v2","CDA","FHIR"],"api_available":"unknown","system_requirements":"","compliance":["FDA 510(k)","CE-MDR","HIPAA","GDPR","SOC 2","ISO 27001"],"certifications":["FDA 510(k)","CE-MDR"],"security_features":["encryption","audit logs","2FA"],"privacy_features":["BAA available","consent management","anonymization","data minimization"],"data_residency":"US/EU regions","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0192","slug":"caddie","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/caddie.json"}}