Medical Device Authorization

Medical Device Authorization is a formal regulatory determination granting permission for the clinical use, market distribution, or operational deployment of a medical device, distinguishing it from other regulatory actions by specifying the conditions under which the device may be legally utilized within defined healthcare environments.

Publications

3.2K

Citations

173

Authors

Institutions

Publications per year

2017–2026

Parents

Medical Device Security

Publications

The state of artificial intelligence-based FDA-approved medical devices and algorithms: an online database

Stan Benjamens, Pranavsingh Dhunnoo, Bertalan Meskó · npj Digital Medicine · 2020 · 1.1K citations · Full text

Computing, Computer Science, Artificial Intelligence +9

How medical AI devices are evaluated: limitations and recommendations from an analysis of FDA approvals

Eric Q. Wu, Kevin Wu, Roxana Daneshjou et al. · Nature Medicine · 2021 · 462 citations

Engineering, Biomedical Engineering, Health Informatics +14

Proximity-based access control for implantable medical devices

Kasper Rasmussen, Claude Castelluccia, Thomas S. Heydt-Benjamin et al. · 2009 · 229 citations

Computing, Computer Science, Cybersecurity +17

Medical Devices — Balancing Regulation and Innovation

Gregory Curfman, Rita F. Redberg · New England Journal of Medicine · 2011 · 144 citations

Pharmacy, Health Law, Health Policy +17

Off-Label Use of Medical Devices in Children

Kathy J. Jenkins, Robert H. Beekman, Michael G. Vitale et al. · PEDIATRICS · 2016 · 73 citations · Full text

Pharmacy, Pediatrics, Surgery +17

1–5 of 49

Authors

173

TC
Tara C. Noone
University of North Carolina at Chapel Hill, United States
2 publications · 61 citations
2
h-index
FM
Francesca Morgante
University of Messina, Italy
2 publications · 61 citations
2
h-index
DS
Devang Sehgal
Atkins (United Kingdom), United Kingdom
2 publications · 61 citations
2
h-index
IG
Ivor Gillbe
UK Dementia Research Institute, United Kingdom
2 publications · 61 citations
2
h-index
JA
Jeffrey A. Herron
University of Wisconsin–Madison, United States
2 publications · 61 citations
2
h-index

1–5 of 173

Institutions

1–8 of 81

Venues

PubMed
Repository · 4 publications · 89 citations
4
h-index
New England Journal of Medicine
NEJM · 3 publications · 243 citations
3
h-index
Injury
2 publications · 67 citations
2
h-index
Medical Law Review
2 publications · 64 citations
2
h-index
Health Policy and Technology
2 publications · 59 citations
2
h-index

1–5