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PubMed

Two Decades of Neurosurgical Device Innovation: A Comprehensive Analysis of FDA Authorization Trends From 7800 Approvals by Subspecialty, Regulatory Pathway, and Approval Time.

PMID: 42975542 ·

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JournalNeurosurgery
Year
PMID42975542

Abstract

Technological progress has accelerated neurosurgical care, yet a panoramic view of these innovations remains lacking. This study aims to analyze all US Food and Drug Administration (FDA) authorizations issued from 2000 to 2023 to map neurosurgical device output by subspecialty, compare regulatory pathways and approval times, and identify factors affecting market entry. All devices cleared or approved by the FDA Neurology and Orthopedic Review Panels (January 2000-December 2023) were extracted fr

Official Source

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