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Medical Devices / Submissions and Approvals

FDA Clears AI-Based Pneumothorax Alert Technology

May 16, 2019
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Zebra Medical’s HealthPNX, an AI-based system for identifying collapsed lung in patients through X-rays or digital radiography, has received 510(k) clearance from the FDA.

The technology uses AI to automatically detect urgent cases of collapsed lung. Users will have relevant scans flagged for the radiologist’s attention.

The AI alert system can potentially lower turnaround time for radiologists and increase their assurance in making collapsed lung diagnoses.

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