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    Evaluation Challenges for the Application of Extended Reality Devices in Medicine.

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    Author
    Beams, Ryan
    Brown, 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
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    Date
    2022-04-25
    Journal
    Journal of Digital Imaging
    Publisher
    Springer Nature
    Type
    Article
    
    Metadata
    Show full item record
    See at
    https://doi.org/10.1007/s10278-022-00622-x
    Abstract
    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.
    Keyword
    Augmented reality
    Image quality
    Medical imaging
    Virtual reality
    Identifier to cite or link to this item
    http://hdl.handle.net/10713/18793
    ae974a485f413a2113503eed53cd6c53
    10.1007/s10278-022-00622-x
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