This framework will highlight safety & effectiveness considerations along with testing approaches and/or evaluation gaps for Human Factors, Image Quality, and Training/Education. Theses chapters include a landscape analysis of considerations for MXR devices for surgical planning and procedures, including healthcare provider safety and user experience, patient safety and user experience, and relevant testing approaches. Additionally, the image quality chapter explains the visualization accuracy considerations and testing for these devices, including lessons learned and degree of overlap with 2D display evaluation methods.
MDIC’s Senior Program Director of Digital Health and Technology (DH&T), Jithesh Veetil, Ph.D., and Associate Director, Clinical Research, Robotics & Digital Solutions for Johnson & Johnson and Medical Extended Reality (MXR) Working Group Lead, Heather Benz, discuss the future of MXR, the rise of augmented reality/virtual reality, how patients benefit from continued investment in MXR, and the progress of MDIC’s MXR Initiative.
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Johnson & Johnson
Director, Clinical Development, Robotics & Digital Solutions
FDA
Physicist in the Division of Imaging, Diagnostics, and Software Reliability (DIDSR), OSEL/CDRH
Digital Health & Technology
Senior Director
Digital Health & Technology
Project Manager