FDA clears GE's AI-powered x-ray algorithms for triaging collapsed lungs

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GE Healthcare has received 510(k) clearance for AI algorithms designed to detect a type of collapsed lung on x-ray images, the company said Thursday. The FDA clearance covers a set of algorithms that GE has embedded in its Optima XR240amx mobile x-ray device, thereby enabling hospitals to access AI capabilities without investing in IT infrastructure. GE, which claims the system is the first AI-powered x-ray device, said the technology will help hospitals identify high-priority cases and fast track their treatment. Turnaround times for chest x-rays vary significantly, even within healthcare institutions. A retrospective chart review conducted in 2018 showed that out of 1,000 chest x-rays ordered with STAT priority, 38% of studies did not indicate clinical urgency, suggesting the status is overused.

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