An AI tool that reads X-rays without any human intervention was given regulatory clearance in the European Union. According to the company called Oxipit, it will be the first fully autonomous medical imaging AI. This is a milestone in the field as the radiologists were pushing back the efforts to fully automate parts of their job. 

The tool, called ChestLink, sends the patients the reports after the scan if it finds the reports to be healthy with no anomalies. However, if the tool finds any potential problems, the reports will be sent to the radiologists for review. According to Oxipit most X-rays in primary care don’t have any issues, so automating the process for those scans would cut down on radiologists’ workloads. 

The tech now has a CE mark certification in the EU, which shows that the device meets the safety standard. The Oxipit spokesperson stated that they are planning to file for Food and Drug Administration (FDA) clearance as well. The FDA has cleared AI devices such as a tool that can detect diabetes-related eye problems, in 2018. However, autonomous radiology devices are more controversial. Professional organizations have released statements against the idea. The American College of Radiology and Radiological Society of North America published a joint letter in 2020 after an FDA workshop on AI in medical imaging saying that autonomous AI was not ready for clinical use.  

However, Oxipit stands that the ChestLink made zero “clinically relevant” errors during the pilot applications. When it was introduced into a new setting, the company said that there should be an audit of existing imaging programs. Then the tool should be used under supervision for some time before it commences autonomous functioning. 

The company expects healthcare organizations to use the tool by 2023.