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PubMed

Neurosurgical software device safety in the US: analysis of 2017-2025 FDA Recall and Adverse Event Data.

PMID: 42967339 ·

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JournalNeurosurgical focus
Year
PMID42967339

Abstract

Neurosurgeons rely on multiple software applications for surgical planning, intraoperative navigation, and neurophysiological monitoring. Combined with the proliferation of AI-based clinical adjuncts, software as a medical device (SaMD) represents an evolving frontier with profound implications for patient safety. The aim of this study was to systematically analyze all software-related neurological medical device recalls initiated in the US from 2017 to 2025 and to assess the implications of rec

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