SmartChest
by Milvue
· Based in France →
— French artificial intelligence for radiology. Diagnose faster, measure effortlessly, prioritize emergencies, give time back to care.
Freemium (for techcare report), subscription (for milvue suite)
Regulatory Status Disclosed
Overview
SmartChest by Milvue is a radiological computer-assisted triage and notification software designed to analyze frontal chest X-ray images (Postero-Anterior (PA) or Antero-Posterior (AP)). It targets transitional adolescents (18-21 years old, treated as adults) and adults (≥22 years old) for the presence of suspected pleural effusion and/or pneumothorax. The software utilizes an artificial intelligence algorithm to identify features suggestive of critical findings and provides case-level output. This output is made available to a PACS (Picture Archiving and Communication System) or other DICOM storage platforms for worklist prioritization. SmartChest functions as a passive notification tool for prioritization only within the standard of care workflow and does not send proactive alerts directly to a medical specialist. Its results are not intended to direct attention to a specific portion of an image or to be used on a stand-alone basis for clinical decision-making.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Radiological computer-assisted triage and notification
- Analyzes frontal chest X-ray images (PA/AP)
- Detects suspected pleural effusion
- Detects suspected pneumothorax
- Provides case-level output for PACS worklist prioritization
- Utilizes AI algorithms for critical findings detection
- Passive notification for prioritization-only
- Cloud-based, hybrid, or locally virtualized deployment options
- Automatic analysis triggered after image acquisition
- Processing time of 1-10 minutes
Use Cases
- Prioritizing chest X-ray interpretations in emergency departments
- Streamlining radiology workflow for faster review of critical cases
- Reducing diagnostic errors in emergency settings
- Improving patient management by reducing waiting times for critical diagnoses
- Supporting radiologists and emergency physicians in interpreting chest X-rays
- Automating initial screening of chest X-rays for specific pathologies
What Physicians Need to Know
DICOM Support & Standards
Milvue SmartChest integrates natively into the DICOM flow and adheres to DICOM, HL7, and IHE standards. AI results are returned in DICOM format (Secondary Capture, Overlay, or GSPS) and are accessible from PACS or any reading console.
PACS Integration Method
SmartChest integrates natively with RIS/PACS, using DICOM in/out. It connects to DICOM sources, the archive, or the imaging device. The results are passively sent via notification to the worklist software (PACS or other platforms) for prioritization.
Reading Room Workflow Impact
SmartChest is designed to fit into existing workflows without requiring workstation changes. It analyzes every radiograph at acquisition, flags fractures, dislocations, joint effusions, and in Europe, pneumothorax, opacities, nodules, and pleural effusions. Critical cases are moved to the top of the worklist, and results are inserted into the report. This can lead to increased productivity and reduced missed findings.
AI Model Architecture (deep learning approach)
Milvue's solutions are built on a reasoned use of deep learning. SmartChest uses artificial intelligence algorithms to analyze images for features suggestive of critical findings.
Processing Speed (per study)
AI analysis, including detection, localization, and confidence scoring, is completed in under 30 seconds. The complete analysis, from image reception to sending results back to PACS, takes less than a minute on average. For pneumothorax detection, the mean execution time is 2.322 ± 0.267 seconds on a local server and 28.542 ± 8.254 seconds on a cloud server. For pleural effusion, it's 2.288 ± 0.165 seconds on a local server and 28.257 ± 7.226 seconds on a cloud server.
FDA Clearance Pathway (510k/De Novo)
SmartChest received FDA 510(k) clearance (K232410) on May 10, 2024, as a Class II device. The 510(k) pathway demonstrates substantial equivalence to a legally marketed predicate device.
Supported Modalities (CT/MRI/X-ray/US)
Milvue primarily analyzes conventional 2D radiographs (X-ray). SmartChest is specifically indicated for chest/thorax X-ray exams. Through partnerships, the Milvue Suite also covers lung nodule detection on CT (2D and 3D), mammography, and tomosynthesis.
Sensitivity & Specificity Data
For pneumothorax, SmartChest has an ROC AUC of 0.989, sensitivity of 92.7%, and specificity of 97.3%. For pleural effusion, it has an ROC AUC of 0.975, sensitivity of 93.3%, and specificity of 90.0%. In fracture detection, the Milvue Suite (which includes SmartChest functionalities for chest) reaches an AUC of 0.962, with comparable performance in children and adults. An independent study showed 90.1% accuracy for fracture detection, outperforming other commercial algorithms. For lung nodule detection on chest radiographs, it achieved an AUC of 0.86, statistically superior to the mean AUC of 17 radiologists (0.81).
RSNA/ACR Validation
Milvue participates in major radiology events like RSNA. A French Multicentre ED Study presented at RSNA 2022 reported 96% sensitivity and 85% specificity for fracture detection. Milvue has numerous scientific publications, including studies in Pediatric Radiology, European Radiology, and Radiology.
Physician Tip
SmartChest acts as a second reader, prioritizing urgent cases and potentially reducing missed findings and speeding up interpretation. However, the AI's results are not intended for stand-alone clinical decision-making, and the radiologist remains in charge of the medical decision. The tool is particularly useful for detecting pneumothorax and pleural effusion on chest X-rays, and its integration into existing PACS workflows means no change to the reading station is required.
SmartChest integrates natively with existing RIS/PACS via DICOM in/out and adheres to HL7 and IHE standards. It can be deployed on-premise, ensuring data security and GDPR compliance. Milvue also partners with other companies like Coreline and Therapixel to extend its capabilities to CT and mammography.
Details
| Category | Radiology & Imaging AI, Triage & ER/ICU AI |
| Pricing | Freemium (for techcare report), subscription (for milvue suite) |
| Free Trial | Unknown |
| Deployment | Cloud-based and on-premise options are available. |
| Mobile App | TechCare Report is available as a web app. |
| Data Export | Unknown |
| Compliance | |
| BAA Available | Unknown |
| HIPAA Compliant | Yes AI-estimated |
| FDA Status | Cleared AI-estimated |
| GDPR | Yes AI-estimated |
| Integrations | |
| EHR | Not specified |
| Specialties | Critical Care, Emergency Medicine, Radiology |
What the Web Says
Milvue's SmartChest is an AI-powered solution designed to assist radiologists in interpreting chest X-rays by detecting and localizing abnormalities such as pneumothorax, pleural effusions, opacities, and nodules. It is FDA-cleared for adults in the United States and CE-marked as a Class IIa medical device in Europe. Physicians have found it to be a simple, intuitive, and valuable tool that integrates seamlessly into existing workflows, aiding in faster diagnoses and improved accuracy.
Overall: PositiveStrengths
- Detects multiple pathologies on chest radiographs, including pneumothorax, effusions, opacities, and nodules.
- Achieved an AUC of 0.86 for lung nodule detection, statistically superior to the mean of 17 radiologists in an independent validation.
- Seamless and intuitive integration into existing radiology workflows without requiring workstation changes.
- Easy to use and interpret, providing instant automated results.
- Helps reduce misdiagnoses, especially for less skilled physicians, and speeds up the diagnostic process for experienced radiologists.
- Enhances physician confidence in decision-making and acts as an efficient second reader.
Limitations
No significant limitations found in public reviews. Consider checking vendor documentation or requesting a demo for a thorough evaluation.
Based on reviews from: milvue.com, aihealthindex.io, aihealthcarenow.com, innolitics.com, nih.gov
Last updated: 2026-10-31
Ratings & Reviews
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Press & Coverage
milvue.com
SmartChest (chest X-ray, adults), FDA 510(k) K232410, Class II device
Milvue's SmartChest, designed for adult chest X-rays, received FDA 510(k) clearance as a Class II medical device on May 10, 2024.
2024-05
radiologybusiness.com
Milvue secures its second FDA clearance, strengthening its leadership in medical AI.
Milvue achieved its second FDA clearance, for TechCare Trauma, in February 2025, reinforcing its position in AI-powered medical imaging.
2025-02
Radiology
Comparison of Commercial AI Software Performance for Radiograph Lung Nodule Detection and Bone Age Prediction
A study published in Radiology in January 2024 compared the performance of commercial AI software for lung nodule detection and bone age prediction on radiographs.
2024-01
Radiology
Commercially Available Chest Radiograph AI Tools for Detecting Airspace Disease, Pneumothorax, and Pleural Effusion
Radiology published a study in September 2023 examining commercially available AI tools for detecting airspace disease, pneumothorax, and pleural effusion on chest radiographs.
2023-09
MDPI
Artificial Intelligence-Based Software with CE Mark for Chest X-ray Interpretation: Opportunities and Challenges
An article in MDPI from June 2023 discusses the opportunities and challenges associated with AI-based software with CE Mark for chest X-ray interpretation.
2023-06
milvue.com
The NHS adopts TechCare Alert
England's NHS has approved several AI platforms for improved fracture detection, including Milvue's TechCare Alert.
2024-XX
milvue.com
Milvue unveils the new version of TechCare Report, the AI assistant for radiological reporting.
Milvue launched an updated version of TechCare Report, an AI assistant designed to optimize the radiological reporting process for various imaging modalities.
2024-XX
milvue.com
Milvue in the Top 10 of Happy Clients 2024
Milvue was recognized as one of the top 10 Happy Clients in France for 2024, ranking 8th in the 1-99 employees category.
2024-XX
Videos
Product demos, reviews, and walkthroughs for SmartChest.
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Frequently Asked Questions
Milvue's SmartChest AI is designed to detect pneumothorax and pleural effusion in adults on chest X-rays in the US. In Europe, the Milvue Suite also detects opacities and pulmonary nodules. For lung nodule detection, it achieved an AUC of 0.86 in an independent validation, which was statistically higher than the mean AUC of 0.81 for 17 radiologists.
SmartChest integrates natively into the DICOM flow and adheres to DICOM, HL7, and IHE standards. AI results are automatically sent back to the same study folder as the native images, making them accessible from the PACS or any reading console without requiring a change of tools.
SmartChest is FDA-cleared in the United States for adults as a Class II device (K232410). In Europe, the Milvue Suite software, which includes chest findings detection, is a Class IIa medical device under EU Regulation MDR 2017/745. Milvue processes health data in compliance with GDPR.
SmartChest is intended as a prioritization tool and does not replace the radiologist's medical decision. It identifies suspected findings for worklist prioritization but its results are not for stand-alone clinical decision-making and it does not send proactive alerts directly to a medical specialist. The device is not a rule-out tool, and the absence of a notification does not exclude pre-specified findings.
While specific direct comparisons to SmartChest are not detailed, Milvue's broader AI platform is noted alongside other AI solutions in radiology, such as those from Olea Medical. Other general AI alternatives mentioned in the context of radiology information systems include Automation Anywhere Agentic Process Automation, Phrase, Alteryx, SAS Viya, and DigitalOcean.
SmartChest processes images and returns results very quickly, with the complete analysis typically taking less than a minute from image reception to sending results back to the PACS. It can analyze up to 5,000 exams per center per day.
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| Last Verified: 2026-04-18 | First Added: 2026-04-18