SmartChest | Chest X-ray triage | USA

FDA | Cardiothoracic & Emergency | X-ray | Amplifier Partner

Amplifier Marketplace Radiology

Description of use

SmartChest analyzes frontal chest radiographs of adults, PA or AP, for suspected pneumothorax and pleural effusion. When it finds one, it sends a passive notification to the PACS. The suspected finding is named in the DICOM tags and a summary image flags the study, so IDS7 can move the exam up the worklist. The notification serves prioritization only, and the radiologist still reads every exam. In the two FDA standalone studies, each on 300 US chest radiographs, SmartChest reached an AUC of 0.989 for pneumothorax and 0.975 for pleural effusion. SmartChest, developed by Milvue, is FDA 510(k) cleared (K232410) as a Class II device (21 CFR 892.2080). It is intended to aid clinicians and does not replace their judgment. Rx only. See the IFU for indications and warnings.

How is the application integrated?

  • Can the end-user read the results in IDS7: Yes
  • DICOM output: DICOM SC summary image, notification in DICOM tags
  • Worklist integration: Yes
  • Pre-populated reports: No

Ask your Sectra representative which version of the Sectra PACS is compatible with the highlighted integration standards.

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Referring articles

The below are peer-reviewed articles that have been submitted by the AI vendor to serve as scientific validation of the application.

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