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

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.