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About the Speakers

Daniel X. Hammer, PhD
Deputy Director
Division of Biomedical Physics (DBP)
Office of Science and Engineering Laboratories (OSEL)
Center for Devices and Radiological Health (CDRH)

Daniel X. Hammer received a B.S. from Rensselaer Polytechnic Institute in 1991 and M.S. and Ph.D. from University of Texas in 1998 and 2001. He has over 25 years’ experience in the invention, development, and application of biomedical optics to a broad range of interdisciplinary research programs. Dr. Hammer has 15 patents and disclosures, >85 peer-reviewed publications, and several book chapters. He is an editor of the book Advances in Optical Imaging for Medicine. His current research interests include optical coherence tomography, adaptive optics, retinal imaging, vision science, and neuro-imaging. He is currently the Deputy Director of the Division of Biomedical Physics (FDA/CDRH/OSEL/DBP), a regulatory science research division at the Food and Drug Administration in Silver Spring, MD. He is a fellow of SPIE and AIMBE and a member of OSA and ARVO.

Zhuolin Liu, PhD
Visiting Scientist
Division of Biomedical Physics (DBP)
Office of Science and Engineering Laboratories (OSEL)
Center for Devices and Radiological Health (CDRH)

Zhuolin Liu received her B.S. and M.S. in optical engineering from China in 2007 and 2010, and a Ph.D. in vision science from Indiana University in 2016. She has over 10 years’ experience in the invention, development, and application of high-resolution biomedical optics in ophthalmology and vision science. Dr. Liu has more than 25 peer-reviewed publications, and several conference proceedings. Her current research area focuses on the development of innovative optical imaging methods, and technologies for use in disease diagnosis, monitoring, and treatment as well as other applications, particularly in ophthalmology, vision science and neuroscience. She is currently a visiting scientist at the Division of Biomedical Physics (FDA/CDRH/OSEL/DBP), a regulatory science research division at the Food and Drug Administration in Silver Spring, MD. She is a member of SPIE, ARVO, and OSA.

About the Presentation

Adaptive optics technologies allow assessment of retinal structure and function at the cellular and sub-cellular level. We will discuss how our adaptive optics regulatory science research program is designed to aid clinical translation via biomarker and clinical endpoint development.

Learning Objectives

After completion of this activity, the participant will be able to:

• Describe the fundamentals of adaptive optics technology and how it fits in the ophthalmic device space.
• Determine differences between structural and functional biomarkers of ophthalmic diseases and the benefits and limitations of each.
• List the barriers to adaptive optics clinical translation.
• Explain how the FDA research program aims to increase patient access to this important technology.

Webcast Recording

https://collaboration.fda.gov/pwsbk2le0e3b/

 

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