FDA-Cleared AI Device

HealthPNX

Nanox AI

Originally cleared under Zebra Medical Vision, HealthPNX screens chest radiographs for suspected pneumothorax and flags positives for prioritized review.

At A Glance

Manufacturer
Nanox AI
Medical specialty
Radiology
Clearance route
510(k)
Year authorized
2019
Modality
Chest X-ray
Role in workflow
Triage and notification

Pneumothorax is a good triage target for the same reason stroke is: the finding is time-critical, visually distinctive, and frequently sits in a long queue of unremarkable chest films. The value is not that software sees it better. It is that software sees it sooner.

Where It Is Used

  • Pneumothorax triage in emergency and inpatient radiography
  • Post-procedure chest film review

Limitations Worth Knowing

Small apical and loculated pneumothoraces are the hardest cases and are exactly where a triage flag would be most useful. Portable and rotated films degrade performance, and those are disproportionately common in the inpatient population being screened.

Regulatory status, indications, and labeling change over time. Confirm current status on the FDA's AI/ML-Enabled Medical Devices list and in the manufacturer's current instructions for use before relying on anything stated here.

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