FDA issues reminder on use of CADt devices

2016 09 02 09 36 05 93 Fda Logo V2 400

The U.S. Food and Drug Administration (FDA) issued a letter July 26 reminding healthcare providers about the intended use of radiological computer-aided triage and notification (CADt) devices.

"Health care providers may not be fully aware that [large vessel occlusion] CADt devices are intended for prioritization and triage only," the FDA's letter stated.

The reminder follows the publication of an FDA-funded study that suggests providers may not be aware of the intended use of these devices, the FDA said.

According to the FDA, large vessel occlusion CADt devices are software devices intended to aid in prioritization and triage of time-sensitive suspected findings of large vessel occlusion based on the analysis of radiological exams of the brain. They do not provide diagnostic information or remove any cases from the imaging physician's reading queue, the letter stated.

"If [large vessel occlusion] CADt devices are not used as intended, there is the potential for misdiagnosis resulting in patient injury or death," the FDA said.

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