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  5. Public Workshop - Medical Extended Reality: Toward Best Evaluation Practices for Virtual and Augmented Reality in Medicine - 03/05/2020 - 03/05/2020
  1. Workshops & Conferences (Medical Devices)

Workshop

Event Title
Public Workshop - Medical Extended Reality: Toward Best Evaluation Practices for Virtual and Augmented Reality in Medicine
March 5, 2020

Scheduled

Date:
March 5, 2020
Time:
8:30 AM - 5:00 PM ET
Location:
Event Location
White Oak Campus: The Great Room
Conference Center

10903 New Hampshire Ave
Building 31, Room 1503
Silver Spring, MD 20993
United States


INTRODUCTION

The Food and Drug Administration (FDA) is announcing the following public workshop entitled "Medical Extended Reality: Toward Best Evaluation Practices for Virtual and Augmented Reality in Medicine." The purpose of the public workshop is to discuss evaluation techniques for hardware, standards development, and assessment challenges for applications of Extended Reality (XR) in medicine. The goal is to identify critical gaps that may impede medical XR device development, innovation, and to advance the evaluation of medical XR devices and applications, thus accelerating the development of safe and effective medical XR devices benefiting patients and healthcare.

We are organizing a public workshop focused on discussing evaluation needs, gaps, and approaches for medical XR devices. The overarching vision of the workshop is to help advance the development of evaluation techniques for medical XR devices and applications to ultimately accelerate the development of safe and effective medical uses of XR, providing benefits to patients. Identifying evaluation technical needs and approaches as well as addressing critical gaps that impede device development is essential for innovation and use of XR in medical applications.

During the workshop, we will be discussing specific topics outlined in the Agenda below.


DATE, TIME and LOCATION

This meeting will be held on March 5, 2020, from 8:30 a.m. to 5:00 p.m. (EST) at the following location:

FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Room 1503 (the Great Room)
Silver Spring, MD, 20993

WEBCAST

The meeting will be webcasted live and the archived link will be posted on the website for viewing after the workshop.

URL for Live Webcast Viewing - https://collaboration.fda.gov/medical030520/

PRELIMINARY AGENDA

The following public workshop Agenda is preliminary and subject to change.  More information will be made available as presenters are confirmed.

Time Event
8:30 AM Opening Remarks
Edward Margerrison (Director, OSEL/CDRH/FDA)
Welcome and event introduction.
  Emerging Technology and Methods I
Moderator: Aldo Badano (Deputy Director, DIDSR/OSEL/CDRH/FDA)
This session will provide an overview of emerging augmented and virtual reality technology, current evaluation methods, and evaluation challenges.
8:40 AM Rafael Grossmann, MD, FACS
Keynote address on extended reality devices in medicine.
9:00 AM Bernard Kress, Microsoft
Advances in mixed reality devices and new evaluation challenges
9:15 AM Hiroshi Mukawa, Sony
Emerging technologies for addressing performance limitations in extended reality devices, such as motion-to-photon latency compensation, and retinal scan displays.
9:30 AM Vinay Narayan, HTC
Advances in virtual reality devices and characterization methods
9:45 AM Don Gyou Lee, LG
Advances in display technology and evaluation challenges
10:00 AM Kevin MacKenzie, Facebook Reality Labs
Next-generation extended reality devices and evaluation methods
10:15 AM Panel Discussion
Discussion on topics from Emerging Technology and Methods I
10:45 AM Coffee Break
  Emerging Technology and Methods II
Moderator: Ryan Beams (DIDSR/OSEL/CDRH/FDA)
This session is part 2 of the emerging augmented and virtual reality technology, current evaluation methods, and evaluation challenges with a greater emphasis on medicine.
11:00 AM Ryan Beams, DIDSR/OSEL/CDRH/FDA
FDA research in characterizing extended reality devices
11:05 AM Hong Hua, University of Arizona
Current research in extended reality devices and evaluation methods
11:20 AM Jennifer Esposito, Magic Leap
Opportunities and challenges for extended reality devices in medicine
11:35 AM Nassir Navab, Johns Hopkins University
Current research in medical applications of extended reality
11:50 AM John Penczek, NIST
Progress in standards for extended reality devices
12:00 PM Panel Discussion
Discussion on topics from Emerging Technology and Methods II
12:30 PM Lunch Brown bag poster session: Medical Extended-Reality Research at the FDA
Andrea Kim, DIDSR/OSEL/CDRH/FDA
  Medical Applications I
Moderator: Kimberly Kontson (DBP/OSEL/CDRH/FDA)
This session addresses current research into the application of extended reality devices and the challenges using these technologies.
1:30 PM Kimberly Kontson, DBP/OSEL/CDRH/FDA
FDA research in human factors challenges for extended reality device
1:35 PM Atul Gupta, Philips
Opportunities and challenges for extended reality devices in medicine
1:50 PM Christoph Leuze, Stanford University
Current research in medical applications of extended reality
2:00 PM Amitabh Varshney, University of Maryland
Current research in medical applications of extended reality
2:10 PM Brennan Spiegel, Cedars-Sinai Medical Center
Clinical research on medical applications of extended reality
2:20 PM Dimitri Amiras, Imperial College Healthcare NHS Trust
Clinical research in medical applications of extended reality
2:30 PM Panel Discussion
Discussion on topics from Medical Applications I
3:00 PM Coffee Break
  Medical Applications II
Moderator: Kyoko Fujimoto (DBP/OSEL/CDRH/FDA)
This session is part 2 of the medical applications with presentations from companies developing medical applications with an emphasis on the evaluation challenges.
3:15 PM Naoji Taniguchi, HoloEyes
Medical image visualization and evaluation challenges using AR
3:20 PM Tassilo Baeuerle/Harald Stock, CognifiSense
Treating pain in VR and the evaluation challenges
3:25 PM Christopher Morley, Medvis
Medical image visualization and evaluation challenges using AR
3:30 PM Jennifer Silva, SentiAR
Medical image visualization and evaluation challenges using AR
3:35 PM Joe Powers, appliedVR
Treating pain in VR and associated evaluation challenges
3:40 PM Ben Lewis, Limbix
Mental health therapy in VR and the evaluation challenges
3:45 PM Tran Tu Huynh, OpticSurg
AR surgery and evaluation challenges
3:50 PM Walter Greenleaf, Stanford University
Current research in medical extended reality devices
3:55 PM Panel Discussion
Discussion on topics from Medical Applications II
4:10 PM Break
  Wrap-up Session
Moderator: Aldo Badano (DIDSR/OSEL/CDRH/FDA)
This session will provide a final panel discussion on extended reality devices in medicine and closing remarks.
4:15 PM Wrap-up Panel Discussion
Discussion on topics spanning the sessions covered in the workshop and follow up activities
5:00 PM Closing Remarks, Aldo Badano (DIDSR/OSEL/CDRH/FDA)

REGISTRATION

Registration is now closed, but you can still use the webcast link to view the workshop.

COMMENTS

Please submit your comments regarding the workshop to https://www.regulations.gov/, Docket No. FDA­ 2020-N-0169 by April 10, 2020.

Please refer to the Instructions for submitting comments to the docket to ensure that your feedback is taken into consideration.

The workshop transcript will be posted in the Docket No. FDA-2020-N-0169 as soon as it is available and accessible at http://www.regulations.gov

CONTACT

For questions regarding public workshop content please contact:

Aldo Badano
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave.
Bldg. 62, Rm. 3116
Silver Spring, MD  20993
301-796-2534
aldo.badano@fda.hhs.gov