"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 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...
