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See the Milvue SuitePneumothorax, nodule, effusion, seen early.
The chest concentrates vital emergencies and screening. The Milvue Suite detects pneumothorax, opacities, pleural effusions and pulmonary nodules (Europe coverage), so nothing slips through the flow.
In short. On chest radiographs, the Milvue Suite flags pneumothorax, pleural effusions, opacities and nodules. In an independent validation (Radiology, 2024), its lung nodule detection reaches an AUC of 0.86, statistically above the mean of 17 radiologists (0.81). Class IIa medical device in Europe; in the United States, SmartChest is FDA cleared for adults (K232410).
The extra eye on every chest.
Pneumothorax, opacities, pleural effusions, pulmonary nodules: chest detection flags and localizes abnormalities, urgent and silent alike.
- Pneumothorax and pleural effusion
- Opacities and pulmonary nodules
- +22% sensitivity in detection
- Critical cases prioritized
Three steps, no workstation change.
Nothing to change at the reading station: the solution slots into your existing flow.
Chest image
PA or lateral radiograph, no specific protocol.
Multi-pathology detection
Abnormalities localized with a confidence score.
Flag & report
Critical cases prioritized, results insert into the report.
A very simple tool to use, easy to interpret, with an instant automated result, on the chest as on the skeleton.
At a glance.
CE-marked medical device, Class IIa, developed by Milvue. Native integration, protected data.
| Modalities | Chest radiography (PA / lat) |
|---|---|
| Pathologies | Pneumothorax, opacity, effusion, nodule |
| Population | Adult and pediatric · Europe coverage only |
| Output | Localized detection, returned on the image |
| Integration | Native RIS / PACS |
| Device | CE marked, class IIa (EU) · FDA: SmartChest (US) * |
Regulatory detail:
- The Milvue Suite (SmartUrgences module), developed by Milvue, is a Class IIa medical device according to EU MDR Regulation 2017/745 - Notified Body: BSI, CE 2797.
- In the United States, SmartChest is FDA cleared (Class II device). Not certified in Canada.
Page updated on October 3, 2026.
Which chest findings does the Milvue Suite detect?
Pneumothorax, pleural effusions, opacities and nodules on chest radiographs (European coverage).
How does it perform on lung nodules?
In an independent validation of seven software products on 386 radiographs (van Leeuwen et al., Radiology, 2024), Milvue reached an AUC of 0.86, statistically above the mean of the 17 radiologist readers (0.81, p = 0.04).
Is chest detection cleared in the United States?
Yes, for adults: SmartChest is FDA cleared (510(k) K232410, May 2024). In Europe, chest detection is part of the Milvue Suite, a Class IIa medical device.