FDA says AI doesn’t exclude LVO cases from radiologist review

The FDA noted that software applications designed for computer-aided triage and notification (CADt) have reached the market that are intended to aid in prioritization and triage of LVO cases based on imaging findings in the brain. LVO is an obstruction of one of the brain’s large arteries and is a common cause of ischemic stroke.

“Health care providers may not be fully aware that LVO CADt devices are intended for prioritization and triage only,” the FDA advisory noted. “These devices should not be relied on when making any diagnostic decisions.”

Use of AI applications for LVO detection…