First autonomous X-ray-analyzing AI is cleared in the EU

An artificial intelligence tool that reads chest X-rays without oversight from a radiologist got regulatory clearance in the European Union last week — a first for a fully autonomous medical imaging AI, the company, called Oxipit, said in a statement. It’s a big milestone for AI and likely to be contentious, as radiologists have spent the last few years pushing back on efforts to fully automate parts of their job.

The tool, called ChestLink, scans chest X-rays and automatically sends patient reports on those that it sees as totally healthy, with no abnormalities. Any images that the tool flags as having a potential problem are sent to a radiologist for review. Most X-rays in primary care don’t have any problems, so automating the process for those scans could cut down on radiologists’ workloads, the Oxipit said in informational materials.

The tech now has a CE mark certification in the EU, which signals that a device meets safety standards. The certification is similar to Food and Drug Administration (FDA) clearance in the United States, but they have slightly different metrics: a CE mark is less difficult to obtain, is quicker, and doesn’t require as much evaluation as an FDA clearance. The FDA looks to see if a device is safe and effective and tends to ask for more information from device makers.

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