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FDA Issues Safety Notice for Imaging Software for Intracranial Large Vessel Occlusion

On April 11, the Food and Drug Administration (FDA) issued a notice reminding health care providers about the intended use of radiological computer-aided triage and notification devices for intracranial large vessel occlusion. The statement includes the following information:


  • Intended use of these devices;
  • Recommendations for health care providers;
  • Actions that the FDA is taking; and
  • Instructions for reporting problems with these devices.


More information on the FDA process for reporting adverse events is available here