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