Evaluation Challenges for the Application of Extended Reality Devices in Medicine.
Author
Beams, RyanBrown, Ellenor
Cheng, Wei-Chung
Joyner, Janell S
Kim, Andrea S
Kontson, Kimberly
Amiras, Dimitri
Baeuerle, Tassilo
Greenleaf, Walter
Grossmann, Rafael J
Gupta, Atul
Hamilton, Christoffer
Hua, Hong
Huynh, Tran Tu
Leuze, Christoph
Murthi, Sarah B
Penczek, John
Silva, Jennifer
Spiegel, Brennan
Varshney, Amitabh
Badano, Aldo
Date
2022-04-25Journal
Journal of Digital ImagingPublisher
Springer NatureType
Article
Metadata
Show full item recordAbstract
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. © 2022, This is a U.S. government work and not under copyright protection in the U.S.; foreign copyright protection may apply.Rights/Terms
© 2022. This is a U.S. government work and not under copyright protection in the U.S.; foreign copyright protection may apply.Identifier to cite or link to this item
http://hdl.handle.net/10713/18793ae974a485f413a2113503eed53cd6c53
10.1007/s10278-022-00622-x
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