EU Clears First Autonomous X-Ray-Analyzing AI

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. 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. Oxipit spokesperson Mantas Miksys told The Verge that the company plans to file with the FDA as well.

Oxipit said in a statement that ChestLink made zero “clinically relevant” errors during pilot programs at multiple locations. When it is introduced into a new setting, the company said there should first be an audit of existing imaging programs. Then, the tool should be used under supervision for a period of time before it starts working autonomously. The company said in a statement that it expects the first healthcare organizations to be using the autonomous tool by 2023.