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BioWorld - Saturday, December 13, 2025
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Home » FDA advises on intended use of software used for patients with intracranial occlusions
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FDA advises on intended use of software used for patients with intracranial occlusions

April 13, 2022
By Mark McCarty
Clinicians are still at liberty to use medical products outside the labeled indication for use, but the U.S. FDA believes radiologists may be unaware of the limitations of radiological computer-aided triage and notification (CADt) software for intracranial large-vessel occlusion (LVOs). The agency advised clinicians that these programs are not intended for use as a substitute for radiologist review of images, but instead should be used only to flag suspect images as part of an effort to triage these patients.
BioWorld MedTech Regulatory Software Artificial intelligence Imaging Digital health U.S. FDA

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