{"product_name":"SmartChest","company_name":"Milvue","product_url":"https://www.milvue.com/us/solutions/smartchest/","company_url":"https://www.milvue.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0218","summary":"SmartChest is an AI-driven solution that assists radiologists in prioritizing chest X-rays by detecting suspected pneumothorax and pleural effusion, thereby enhancing workflow efficiency and diagnostic accuracy.","description":"SmartChest is an AI-powered image processing device designed to aid in the triage of chest X-rays, specifically identifying suspected pneumothorax and pleural effusion. It integrates directly into the practitioner's workstation, automatically analyzing chest X-rays and flagging examinations that require prompt attention. This integration facilitates timely notifications to clinicians, streamlining the review process and improving patient care. SmartChest is a Class II medical device, FDA-cleared, and intended for use with frontal AP and PA views in chest radiographs of adults and transitional adolescents. It does not replace radiologists but enhances their capabilities by providing decision support and improving productivity. The solution has been validated on independent datasets, demonstrating high sensitivity and specificity for detecting pneumothorax and pleural effusion. It is available in the United States and Europe, with plans for broader international availability. The company, Milvue, was founded in 2018 and has offices in France, Canada, and the United States.","categories":["clinical Care","imaging Software","radiology","ai Clinical Documentation Integrity","clinical Decision Support","medical Device","Clinical","Diagnostic Imaging","Radiology","Artificial Intelligence","Medical Device"],"market_segment":["Enterprise","SMB"],"target_users":["Radiologists","Emergency Physicians","Clinicians"],"specialties":["Radiology","Emergency Medicine","Pulmonology"],"regions_available":["United States","Europe"],"languages_supported":["English","French"],"pricing_model":"Subscription","pricing_details":"Contact vendor for pricing information.","license":"Commercial","company_offices":["France","Canada","United States"],"company_founding":"2018","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web","iOS","Android","Windows","macOS","Linux"],"features":["Triage of pneumothorax","Triage of pleural effusion","Integration with PACS","Integration via AI marketplace or distribution platform","Automatic analysis trigger post-image acquisition","Processing time: 1 - 10 minutes","Direct integration with practitioner's workstation","Clinician notifications for time-sensitive images"],"optional_modules":[],"integrations":["PACS","AI marketplace","distribution platform"],"data_standards":["DICOM"],"api_available":"unknown","system_requirements":"Virtual machine, Docker, Cloud-based infrastructure","compliance":["FDA 510(k) cleared","Class II medical device"],"certifications":["FDA 510(k) cleared","Class II medical device"],"security_features":["Data encryption","Role-based access control","Audit logs","Two-factor authentication","Data loss prevention"],"privacy_features":["Business Associate Agreement available","Consent management","Anonymization","Data minimization"],"data_residency":"US","customers":["Services d'imagerie ViaMedica","International Radiology Center","Consultant Paediatric Radiologist","IMRO","GHT Haut Bugey","Riviera Imagerie"],"user_reviews":["The interest of the medical imaging community in AI is amply demonstrated. Initial predictions about the disappearance of the specialty have given way to recognition of the enormous potential of AI to improve the work of radiologists. We have undertaken to optimize the use of AI in our practice in order to improve the quality of our service. I am very happy to be able to count on Milvue as a partner in this initiative.","This impressive AI solution accurately identifies several chest X-ray findings, particularly the tricky ones, which helps improve our team’s confidence in making decisions. With the generated results timely and conveniently displayed on our reading stations, Milvue acts as an efficient 2nd reader.","I had the pleasure of trailing the Milvue solution in my academic research for chest and musculoskeletal radiograph interpretation. I found the tool very user-friendly, easy to interpret and provided an instant automated result.","The introduction of this new tool was simple and natural. The adoption of AI was made easy through its seamless and intuitive integration into our daily workflow. All team members quickly embraced the Milvue solution.","An innovative solution that addresses a security need by enhancing physicians’ capabilities.","The Milvue Solution is a comprehensive and user-friendly solution that enhances analytical capacity while ensuring secure diagnostics. The intelligent management of multiple pathologies within a single solution is a significant advantage because, in many cases, detecting fractures alone is not sufficient. It has become an essential assistant today for handling the continuous flow of X-rays."],"ratings":["FDA 510(k) clearance, Class II medical device","CE 2797, Class IIa medical device","Health Canada approval, Class IIa medical device","96% user satisfaction rate"],"support_channels":["email","phone","chat","ticketing","community","24x7"],"training_options":["documentation","webinars","live_online","onsite","certification"],"release_year":"2024","integration_partners":["Coreline Soft","Therapixel","NUBIX","Azure OpenAI Service","Azure AI Studio"],"id":"SW0218","slug":"smartchest","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/smartchest.json"}}