Carlos Rodrigo Goulart

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

OBJECTIVE 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 w...