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Neurologic Medical Device Overview for Pathologists.

Authors :
Cramer SD
Lee JS
Butt MT
Paulin J
Stoffregen WC
Source :
Toxicologic pathology [Toxicol Pathol] 2019 Apr; Vol. 47 (3), pp. 250-263. Date of Electronic Publication: 2019 Jan 01.
Publication Year :
2019

Abstract

Thorough morphologic evaluations of medical devices placed in or near the nervous system depend on many factors. Pathologists interpreting a neurologic device study must be familiar with the regulatory framework affecting device development, biocompatibility and safety determinants impacting nervous tissue responses, and appropriate study design, including the use of appropriate animal models, group design, device localization, euthanasia time points, tissue examination, sampling and processing, histochemistry and immunohistochemistry, and reporting. This overview contextualizes these features of neurologic medical devices for pathologists engaged in device evaluations.

Details

Language :
English
ISSN :
1533-1601
Volume :
47
Issue :
3
Database :
MEDLINE
Journal :
Toxicologic pathology
Publication Type :
Academic Journal
Accession number :
30599801
Full Text :
https://doi.org/10.1177/0192623318816685