The U.S. Food and Drug Administration (FDA) is reminding health care providers about the intended use of radiological computer-aided triage and notification (CADt) devices for intracranial large vessel occlusion (LVO). LVO is an obstruction of one of the large arteries in the brain and is a common cause of acute ischemic strokes. LVO CADt devices are software devices intended to aid in prioritization and triage of time-sensitive suspected findings of LVO based on the analysis of radiological exams of the brain. LVO CADt devices do not provide diagnostic information or remove any cases from the imaging physician’s reading queue. Information from real-world use suggests that providers may not be aware of the intended use of these devices. If LVO CADt devices are not used as intended, there is the potential for misdiagnosis resulting in patient injury or death. The FDA is bringing this information to your attention as a reminder and to ensure that providers are aware of the intended use of the software as a triage and prioritization tool.
The FDA recommends that health care providers:
Be aware that LVO CADt devices only flag radiological exams with suspected findings and should never be used as a replacement for informed interpretation by an imaging physician.
Recognize that LVO CADt devices cannot rule out the presence of an LVO. If a radiological exam is not flagged by a LVO CADt device, an LVO may still be present. If a radiological exam is not flagged by a LVO CADt device, an LVO may still be present.