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