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dc.contributor.authorBeams, Ryan
dc.contributor.authorBrown, Ellenor
dc.contributor.authorCheng, Wei-Chung
dc.contributor.authorJoyner, Janell S
dc.contributor.authorKim, Andrea S
dc.contributor.authorKontson, Kimberly
dc.contributor.authorAmiras, Dimitri
dc.contributor.authorBaeuerle, Tassilo
dc.contributor.authorGreenleaf, Walter
dc.contributor.authorGrossmann, Rafael J
dc.contributor.authorGupta, Atul
dc.contributor.authorHamilton, Christoffer
dc.contributor.authorHua, Hong
dc.contributor.authorHuynh, Tran Tu
dc.contributor.authorLeuze, Christoph
dc.contributor.authorMurthi, Sarah B
dc.contributor.authorPenczek, John
dc.contributor.authorSilva, Jennifer
dc.contributor.authorSpiegel, Brennan
dc.contributor.authorVarshney, Amitabh
dc.contributor.authorBadano, Aldo
dc.date.accessioned2022-05-09T12:30:53Z
dc.date.available2022-05-09T12:30:53Z
dc.date.issued2022-04-25
dc.identifier.urihttp://hdl.handle.net/10713/18793
dc.description.abstractAugmented 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.en_US
dc.description.urihttps://doi.org/10.1007/s10278-022-00622-xen_US
dc.language.isoenen_US
dc.publisherSpringer Natureen_US
dc.relation.ispartofJournal of Digital Imagingen_US
dc.rights© 2022. This is a U.S. government work and not under copyright protection in the U.S.; foreign copyright protection may apply.en_US
dc.subjectAugmented realityen_US
dc.subjectImage qualityen_US
dc.subjectMedical imagingen_US
dc.subjectVirtual realityen_US
dc.titleEvaluation Challenges for the Application of Extended Reality Devices in Medicine.en_US
dc.typeArticleen_US
dc.identifier.doi10.1007/s10278-022-00622-x
dc.identifier.pmid35469355
dc.source.journaltitleJournal of digital imaging
dc.source.countryUnited States


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