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Intended Use of Imaging Software for Intracranial Large Vessel Occlusion

The FDA issued a Letter to Health Care Providers to remind health care providers of the intended use of radiological computer-aided triage and notification (CADt) devices for intracranial large vessel occlusion (LVO) as a triage and prioritization tool that does not provide diagnostic information. Information from real-world use suggests that providers may not be aware of the intended use of these software devices and of the potential for misdiagnosis if they are not used as intended.

The Letter to Health Care Providers includes important information about LVO CADt devices, including:

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

Questions?

If you have questions about LVO CADt devices, contact the Division of Industry and Consumer Education (DICE).