Announces FDA 510(k) Clearance for Additional CXR Findings has expanded its portfolio of FDA 510(k) cleared findings for chest X-ray to a total of five. We now offer the highest number of findings for triage and notification on chest X-ray in the U.S. market. Cleared chest X-ray findings include:

  • Pleural effusion
  • Pneumoperitoneum
  • Vertebral compression fracture
  • Pneumothorax
  • Tension pneumothorax received its first FDA clearance in February 2022 for the triage and notification of pneumothorax on chest X-ray. It is the first product available in the U.S. market to differentiate a tension pneumothorax, allowing a clinical site to apply specific triaging rules for the most urgent tension pneumothorax cases.

This builds on our momentum in the U.S and brings FDA 510(k) cleared findings to a total of nine, including four findings for triage and notification of non-contrast head CTs.

Click here to read the full press release.

A comprehensive decision-support tool. Powered by AI. Visit Web demo