Logos

Webcast/Handouts

View the Webcast Part 1
View the Webcast Part 2
View the Transcript

Agenda: The Forum will focus on the latest trends and enhancements in laser-based imaging modalities such as Optical Coherence Tomography (OCT) and Adaptive Optics (AO), regulatory and reimbursement considerations, and new topics of interest such as the Medical Device Development Tool Program and the emerging role of Artificial Intelligence.

• Welcome and Introductory Remarks: Malvina Eydelman, MD & David Myung, MD, PhD (Handouts)

Session 1: Optical Coherence Tomography (OCT)
• FDA Regulation of OCT: Brad Cunningham, MS (Handouts)
• Novel applications of leading edge OCT for the diagnosis and treatment of anterior segment disease: Mitchell Weikert, MD (Handouts)
• Clinical standards for assessment of novel anterior segment measurements: Yasmin Bradfield, MD (Handouts)
• Novel applications of leading-edge OCT in the diagnosis and treatment of glaucoma: Joel S. Schuman, MD, FACS (Handouts)
• Novel applications of leading edge OCT in the diagnosis and treatment of retinal disease: Richard Spaide, MD (Handouts)
• Clinical standards for assessment of novel posterior segment measurements for retinal disease and glaucoma: SriniVas R. Sadda, MD (Handouts)
• AI-assisted segmentation: Michael F. Chiang, MD (Handouts)
Panel Discussion (Question 1)
Moderator: Mark Blumenkranz, MD
Panelists: Theodore Leng, MD, MS; Mays El-Dairi, MD; Alastair Denniston, MA, MRCP, PhD; Brad Cunningham, MS; Michael D. Abramoff, MD, PhD; Felipe Medeiros, MD; Lama Al-Aswad, MD; Frank Brodie, MD; Nadia Waheed, MD, MPH (Handouts)

Session 2: Adaptive Optics (AO)
• Adaptive Optics introduction and use in imaging devices: Alfredo Dubra, PhD (Handouts Not Available)
• Clinical uses of Adaptive Optics: Jacque L. Duncan, MD (Handouts Not Available)
• Summary of research applications and how these may lead to clinical trials: Austin Roorda, PhD (Handouts)
• Regulatory considerations for Adaptive Optics Technology: Larry Kagemann, PhD (Handouts)
Panel Discussion (Question 2)
Moderator: Cathy Cukras, MD, PhD
Panelists: Richard Rosen, MD; Jessica I. W. Morgan, PhD; Nicolas Chateau, PhD (Handouts)

Session 3: Nonclinical Data Sources
• Synthetic datasets (Phantom, Images) and their utility: Anant Agrawal, PhD (Handouts)
• Principles of the Medical Device Development Tool program: Hilda Scharen, MSc, Capt USPHS (Handouts)
Panel Discussion (Question 3)
Moderator: Natalie A. Afshari, MD
Panelists: Joseph Carroll, PhD; Alfredo Dubra, PhD; Daniel Hammer, PhD; Vivek Srinivasan, PhD (Handouts)

Session 4: Reimbursement
• Reimbursement considerations, include coding and coverage (government and commercial payers): Michael X. Repka, MD, MBA (Handouts)
• CDRH Payer Program: Rochelle Fink, MD, JD (Handouts Not Available)
Panel Discussion (Question 4)
Moderator: Michael X. Repka, MD, MBA
Panelists: David Glasser, MD; Allison Shuren, MSN; Laurence J. Clark, MD, FACP; Cynthia G. Mattox, MD; Christopher J. Quinn, OD; Pierre Yong, MD (Handouts)