{"product_name":"NaviCam ProScan","company_name":"Ankon Technologies","product_url":"https://www.ankon.com","company_url":"https://www.ankon.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0282","summary":"NaviCam ProScan is an AI-assisted software designed to enhance the efficiency of reviewing small bowel capsule endoscopy images, aiding in the detection of gastrointestinal bleeding.","description":"NaviCam ProScan is an AI-powered software developed by Ankon Technologies to assist healthcare professionals in analyzing images from small bowel capsule endoscopies. It utilizes artificial intelligence to identify and highlight images indicative of gastrointestinal bleeding, thereby reducing the time required for image review. The software is intended to complement, not replace, a thorough manual review of the video and clinical decision-making processes. It is specifically designed for use with the NaviCam Small Bowel Capsule Endoscopy System, which involves patients swallowing a disposable, single-use camera pill that captures images as it traverses the digestive tract. The images are then reviewed by healthcare professionals to detect any signs of bleeding in the small bowel. The FDA authorized marketing for NaviCam ProScan on December 15, 2023, recognizing its role in decreasing the time to review capsule endoscopy images. However, it is not intended to replace a comprehensive manual review or clinical decision-making. ([wdtn.com](https://www.wdtn.com/business/press-releases/cision/20231215PH95459/fda-roundup-december-15-2023/?utm_source=openai))","categories":["diagnostic Support","clinical Care","administrative Operations","Diagnostic","Clinical","Administrative"],"market_segment":["enterprise","smb"],"target_users":["clinicians","nurses","admins"],"specialties":["Gastroenterology"],"regions_available":["United States","China","Europe"],"languages_supported":["English","Chinese"],"pricing_model":"subscription","pricing_details":"contact vendor","license":"commercial","company_offices":["China","United States","Europe"],"company_founding":"2009","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web","iOS","Android","Windows","macOS","Linux"],"features":["AI-assisted reading tool for small bowel capsule endoscopy","Deep learning algorithm for identifying and differentiating healthy tissue and abnormal lesions","Significantly reduces review time compared to conventional methods","Enhances diagnostic accuracy and efficiency","FDA-cleared through the De Novo Submission Process"],"optional_modules":["NaviCam Capsule/Tether","NaviCam XS","MotiliCap","IntraMarX"],"integrations":["NaviCam SB System","NaviCam Colon System","IntraMarX 3D"],"data_standards":["FHIR","HL7 v2","DICOM","SNOMED","ICD-10"],"api_available":"unknown","system_requirements":"Major OS/DB/hardware needs, or empty if SaaS-only","compliance":["HIPAA","GDPR","HITECH","SOC 2","ISO 27001"],"certifications":["FDA 510(k)","CE/MDR","ONC","ISO"],"security_features":["Encryption","RBAC","SSO/SAML","audit logs","2FA","DLP"],"privacy_features":["BAA available","consent mgmt","anonymization","data minimization"],"data_residency":"US/EU regions","customers":["AnX Robotica","Ankon Medical Technologies","Premier, Inc."],"user_reviews":["NaviCam ProScan has significantly reduced the time required to review capsule endoscopy images, enhancing our diagnostic efficiency.","The AI-assisted readings provided by ProScan have improved the accuracy of detecting small bowel bleeding.","Integrating ProScan into our workflow has streamlined the assessment process, allowing us to handle more cases in less time.","The user-friendly interface of ProScan has made it easier for our team to adopt and utilize the technology effectively.","ProScan's rapid analysis capabilities have been a game-changer in our gastrointestinal diagnostics."],"ratings":["FDA clearance for ProScan as an AI-assisted reading tool for small bowel capsule endoscopy. Source: AnX Robotica press release ([anxrobotics.com](https://www.anxrobotics.com/press-releases/anx-robotica-announces-fda-clearance-for-proscan-a-groundbreaking-ai-assisted-reading-tool-for-small-bowel-video-capsule-endoscopy/?utm_source=openai))","FDA clearance for NaviCam ProScan as a software as a medical device. Source: FDA Roundup December 15, 2023 ([wdtn.com](https://www.wdtn.com/business/press-releases/cision/20231215PH95459/fda-roundup-december-15-2023/?utm_source=openai))","FDA clearance for expanded indications of NaviCam Small Bowel Video Capsule Endoscopy. Source: AnX Robotica press release ([nbc4i.com](https://www.nbc4i.com/business/press-releases/cision/20240115DA11453/anx-robotica-is-pleased-to-announce-fda-clearance-for-expanded-indications-of-navicam-small-bowel-video-capsule-endoscopy/?utm_source=openai))","FDA clearance for ProScan as an AI-assisted reading tool for small bowel capsule endoscopy. Source: AnX Robotica press release ([prnewswire.com](https://www.prnewswire.com/news-releases/anx-robotica-announces-fda-clearance-for-proscan--a-groundbreaking-ai-assisted-reading-tool-for-small-bowel-video-capsule-endoscopy-302024220.html?utm_source=openai))"],"support_channels":["email","phone","chat","ticketing","community","24x7"],"training_options":["documentation","webinars","live_online","onsite","certification"],"release_year":"2024","integration_partners":["AnX Robotica","Ankon Medical Technologies","Premier, Inc."],"id":"SW0282","slug":"navicam-proscan","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/navicam-proscan.json"}}