GE Healthcare's AI X-ray device 1st to receive FDA clearance

The FDA cleared GE Healthcare's Critical Care Suite, the first artificial intelligence-powered mobile X-ray device for triage of pneumothorax cases to receive marketing authorization from the agency.

The device is powered by GE's Edison AI platform and was developed in partnership with the University of California San Francisco. Its algorithms immediately scan imaging data to alert radiologists to potentially collapsed lungs, significantly reducing the average time needed for clinicians to review suspected pneumothorax from nearly eight hours to just a matter of minutes.

"Not only does Critical Care Suite flag images with a suspected pneumothorax with impressive accuracy and enable radiologists to prioritize those cases immediately, but it also makes AI accessible," Jie Xue, president and CEO of X-ray at GE Healthcare, said in a statement. "Our embedded AI algorithms offer hospitals an opportunity to try AI without making investments into additional IT infrastructure, security assessments or cybersecurity precautions for routing images offsite."

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