FDA Clears GE Healthcare's Critical Care Suite Chest X-ray AI
September 12, 2019 – GE Healthcare announced the U.S. Food and Drug Administration’s (FDA) 510(k) clearance of Critical Care Suite, a collection of artificial intelligence (AI) algorithms embedded on a mobile X-ray device. Built in collaboration with UC San Francisco (UCSF) using GE Healthcare’s Edison platform, the AI algorithms help to reduce the turn-around time it can take for radiologists to review a suspected pneumothorax, a type of collapsed lung.
A prioritized “STAT” X-ray can sit waiting for up to eight hours for a radiologist’s review[1]. However, when a patient is scanned on a device with Critical Care Suite, the system automatically analyzes the images by simultaneously searching for a pneumothorax. If a pneumothorax is suspected, an alert — along with the original chest X-ray — is sent directly to the radiologist for review via picture archiving and communication systems (PACS). The technologist also receives a subsequent on-device notification[2] to give awareness of the prioritized cases. Quality-focused AI algorithms simultaneously analyze and flag protocol and field-of-view errors as well as auto-rotate the images on-device. Critical Care Suite and the quality algorithms were developed using GE Healthcare’s Edison platform – which helps deploy AI algorithms quickly and securely – and deployed on the company’s Optima XR240amx system.
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