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

An artificial intelligence tool that reads chest X-rays without the supervision of a radiologist received regulatory approval in the European Union last week — a first for fully autonomous medical imaging AI, the company, called Oxipit, said in a statement. statement† It’s a big milestone for AI and is likely to be controversial as radiologists have made efforts in recent years to fully automate parts of their work.

The tool, called ChestLink, scans chest X-rays and automatically sends patient reports about those it considers completely healthy, with no abnormalities. Any images flagged by the tool as a potential problem are sent to a radiologist for review. Most primary care X-rays have no problems, so automating the process for those scans could reduce radiologists’ workload, the Oxipit said in informative material

The tech now has a CE mark in the EU, which indicates that a device meets safety standards. The certification is similar to the Food and Drug Administration (FDA) approval in the United States, but they have something: different statistics: A CE mark is less difficult to obtain, is faster and does not require as much evaluation as an FDA approval. The FDA checks whether a device is safe and effective and tends to demand more information from device manufacturers.

Oxipit spokesperson Mantas Miksys said: The edge that the company also plans to file with the FDA.

The FDA has previously approved autonomous AI devices, starting with a tool that can detect diabetes-related eye problems in 2018 (the same tool received a CE mark) in 2013† But autonomous radiology devices are more controversial† Professional organizations have spoken out against the idea: the American College of Radiology and the Radiological Society of North America published a joint letter in 2020 following an FDA workshop on artificial intelligence in medical imaging, which said autonomous AI was not yet ready for clinical use. So far, they said, AI programs have been too inconsistent and often didn’t perform as well on groups of patients outside of the original environments they were built into.

Oxipit said in a statement that ChestLink made zero “clinically relevant” errors during pilot programs at multiple locations. When introduced to a new environment, the company said it would require an audit of existing imaging programs first. Then the tool needs to be used under supervision for a while before it starts working autonomously.

The company said in a statement it expects the first healthcare organizations to start using the autonomous tool by 2023.


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