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# FDA Alert on Vessel Occlusion CADt Devices
- URL: https://www.fdaweb.com/fda-alert-on-vessel-occlusion-cadt-devices/
- Published: 2022-04-11T12:00:00.000Z
- Updated: 2026-09-14T17:40:05.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5151562

FDA says healthcare providers may not be fully aware that the intended use of radiological computer-aided triage and notification (CADt) devices for [intracranial large vessel occlusion](https://medlineplus.gov/ischemicstroke.html?ref=fdaweb.com) (LVO) is to triage suspected findings of LVO based on the analysis of brain radiological exams. CDRH is working with LVO CADt device manufacturers to ensure that health care providers are informed about the intended use and design of these devices. “More generally, because postmarket performance in clinical practice may not match the premarket data, the FDA is also engaged in continuing efforts to evaluate the real-world performance of AI/ML imaging devices, including CADt devices,” the Center says.

LVO is an obstruction of one of the large arteries in the brain and is a common cause of acute ischemic strokes. Because the software devices are intended to aid in prioritization and triage of time-sensitive suspected findings of LVO based on the analysis of brain radiological exams, the agency says the devices should not be relied on when making any diagnostic decisions. In addition, “health care providers should ensure that they understand which vessels the device was designed and tested to evaluate. If the device is used for diagnostic decisions or to evaluate vessels for which it was not designed, delayed or missed diagnoses may occur and result in worsened outcomes for patients.”

A just-posted [letter](https://www.fda.gov/medical-devices/letters-health-care-providers/intended-use-imaging-software-intracranial-large-vessel-occlusion-letter-health-care-providers?ref=fdaweb.com) to healthcare providers reminds them to:

- 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.
- Recognize that when the device is used as intended (as a prioritization and triage tool and not a diagnostic device), it can improve workflow by prioritizing suspected cases.