Evaluation Challenges for the Application of Extended Reality Devices in Medicine.
Augmented reality
Image quality
Medical imaging
Virtual reality
Journal
Journal of digital imaging
ISSN: 1618-727X
Titre abrégé: J Digit Imaging
Pays: United States
ID NLM: 9100529
Informations de publication
Date de publication:
10 2022
10 2022
Historique:
received:
18
11
2021
accepted:
08
03
2022
revised:
04
02
2022
pubmed:
27
4
2022
medline:
22
10
2022
entrez:
26
4
2022
Statut:
ppublish
Résumé
Augmented and virtual reality devices are being actively investigated and implemented for a wide range of medical uses. However, significant gaps in the evaluation of these medical devices and applications hinder their regulatory evaluation. Addressing these gaps is critical to demonstrating the devices' safety and effectiveness. We outline the key technical and clinical evaluation challenges discussed during the US Food and Drug Administration's public workshop, "Medical Extended Reality: Toward Best Evaluation Practices for Virtual and Augmented Reality in Medicine" and future directions for evaluation method development. Evaluation challenges were categorized into several key technical and clinical areas. Finally, we highlight current efforts in the standards communities and illustrate connections between the evaluation challenges and the intended uses of the medical extended reality (MXR) devices. Participants concluded that additional research is needed to assess the safety and effectiveness of MXR devices across the use cases.
Identifiants
pubmed: 35469355
doi: 10.1007/s10278-022-00622-x
pii: 10.1007/s10278-022-00622-x
pmc: PMC9582055
doi:
Types de publication
Journal Article
Research Support, U.S. Gov't, P.H.S.
Research Support, U.S. Gov't, Non-P.H.S.
Langues
eng
Sous-ensembles de citation
IM
Pagination
1409-1418Informations de copyright
© 2022. This is a U.S. government work and not under copyright protection in the U.S.; foreign copyright protection may apply.
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