Improper Use of Imaging Software for Intracranial Large Vessel Occlusion Could Result In Patient Deaths, FDA Warns

Relying on certain imaging software to make diagnostic decisions regarding potential strokes can lead to a risk of misdiagnosis or even death, according to a new warning by federal regulators.

The U.S. Food and Drug Administration (FDA) issued a letter to healthcare providers on April 11, calling on doctors not to rely on radiological computer-aided triage and notification (CADt) devices to diagnose some types of strokes.

While these devices can flag potential intracranial large vessel occlusions (LVOs), using them to rule out potential signs of a stroke is a mistake, as they were not designed for that purpose, the agency warns.

The FDA letter urged healthcare providers to fully understand that CADt devices, which are used to detect intracranial large vessel occlusions (LVO), are actually software devices intended to help prioritize suspected findings and time-sensitive issues. However, the software is not meant to take the place of doctor diagnostic evaluation and decision.

Intracranial LVOs are obstructions of one of the large arteries in the brain, and a common cause of acute ischemic strokes.

CADt devices use artificial intelligence learning and technology, which is intended to help prioritize potential findings that may be time-sensitive and could significantly affect a patient. Although the software offers a recommendation after the device is used, doctors should continue to evaluate the imaging and make a treatment decision based on their training and expertise. Failing to do so can lead to missed diagnosis or worsened outcomes for patients, according to the federal health officials.

The FDA letter warned LVO CADt devices do not provide diagnostic information or remove any cases from the imaging physicians reading queue, essentially warning doctors not to use CADt devices to make a final diagnostic determination.

If the devices are not used as intended, there is potential for misdiagnosis which can lead to patient injury or even death.

The agency recommends doctors be fully aware that the devices only flag radiological exams with suspected findings and should not be used to replace an informed interpretation by the physician. The FDA also urges doctors to understand the devices cannot rule out the presence of an LVO, which may still be present even if the software does not flag a potential LVO.

When used as intended, exams not flagged by the CADt device will still be examined and interpreted by an imaging physician. The FDA continues to work with LVO CADt device manufacturers to inform doctors of the intended use and design and evaluate the performance of the devices in real patient settings.

Healthcare providers should report any adverse events or suspected adverse events experienced with imaging software or CADt devices to the FDA’s MedWatch Adverse Event Reporting Program.