FDA warns about misuse of stroke AI detection technology

The U.S. Food and Drug Administration issued a letter to healthcare providers April 11 reminding them that AI programs for detecting strokes are currently not a replacement for radiologist interpretation of images.

Some providers may not be using radiological computer-aided triage and notification devices for intracranial large vessel occlusion as intended, according to the agency. 

These programs, designed to prioritize incoming brain scans and alert physicians to time-sensitive stroke patients, are not meant to provide stand-alone or definitive diagnostic information or suggest that lower-priority cases be ruled out and deleted from a physician's reading queue, according to the letter. 

The FDA letter said that misuse of the technology has the potential for missed diagnoses, patient injuries and death. 

The agency said providers should be aware that these programs "only flag radiological exams with suspected findings and should never be used as a replacement for informed interpretation by an imaging physician." 

The FDA is working with AI and machine learning developers to make sure healthcare providers are properly instructed about the programs' intended uses and design. 

The agency is also encouraging healthcare providers to report any adverse events or suspected adverse events experienced with imaging software for large vessel occlusion.

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