• Top FDA Ophthalmologist Urges Academy Members to Help Shape Next-Gen Laser Imaging Policies


    The top ophthalmologist in the Food and Drug Administration’s Center for Devices and Radiological Health is urging Academy members to be a part of a robust discussion of next-generation laser imaging in our profession. The agency will host a forum on this topic on April 8 in Silver Spring, Md., which includes novel applications of optical coherence tomography and adaptive optics. Several Academy members will participate as panelists. In an interview with the Academy, Malvina B. Eydelman, MD, encourages more ophthalmologists to attend in order to help inform the FDA’s decision-making and facilitate innovation of safe, effective imaging diagnostics. 

    You can attend this forum in person or participate online. Register today to join Dr. Eydelman.

    Forum goals

    Dr. Eydelman: Our goal for this forum is to encourage a rich public discussion that may help inform the FDA’s decision-making and facilitate innovation of safe and effective imaging diagnostics, such as novel applications of OCT and adaptive optics. 

    In addition, the last session of the day will highlight the FDA’s Payor Communication Task Force and identify potential opportunities to shorten the time between FDA marketing decisions and coverage decisions by both public payors and private health plans. 

    What attendees will learn at this workshop

    Dr. Eydelman: There are several elements of the workshop that may be of interest to Academy members. There will be presentations and panel discussions on new technologies and applications for laser-based imaging devices, the latest developments in OCT and adaptive optics and the integration of artificial intelligence. 

    In addition to the topics, the workshop is a great opportunity for Academy members to contribute to the discussion and help shape the future of ophthalmic devices. 

    Biggest challenges for FDA as innovation continues in laser-based imaging modalities like OCT and Adaptive Optics

    Dr. Eydelman: As the Center for Devices and Radiological Health at FDA, we have the responsibility of evaluating medical devices so that patients in the U.S. have access to high-quality, safe and effective medical devices. As with any novel technology, we may face challenges on how best to evaluate safety and effectiveness. 

    For example, which clinical reference standards and other evaluation tools should be used to evaluate novel technology that generates new imaging information. Or, how might adaptive optics be used in the management of certain disease of the eye.  

    Ideally, the public dialog among FDA and its stakeholders – industry, academia, professional organizations and the medical community – will help to develop appropriate reference standards and performance considerations to ensure appropriate validation. 

    Forum on Laser-Based Imaging

    Monday, April 8
    8 a.m. to 4:30 p.m.
    Tommy Douglas Conference Center
    Silver Spring, Md.

     

    Agenda

     

    8 a.m.

    Breakfast/Exhibit Hall

    8:30 a.m.

    Welcome and Introductory Remarks: Malvina B. Eydelman, MD, & David Myung, MD, PhD


    Session 1: Optical Coherence Tomography (OCT)

    8:45 a.m.

    FDA Regulation of OCT: Brad Cunningham, MS

    9:05 a.m.

    Novel applications of leading-edge OCT in anterior segment: TBD

    9:20 a.m.

    Clinical standards for assessment of novel anterior segment measurements: TBD

    9:35 a.m.

    Novel applications of leading-edge OCT in posterior segment: Joel Schuman, MD

    9:50 a.m.

    Clinical standards for assessment of novel posterior segment measurements: SriniVas Sadda, MD

    10:05 a.m.

    Break/Exhibit Hall

    10:25 a.m.

    AI-assisted segmentation: Michael Chiang, MD

    10:40 a.m.

    Panel Discussion (Question 1)
    Moderator: Mark Blumenkranz, MD
    Panelists: Ted Leng, MD, FACS; Mays El-Dairi, MD; Allistair Denniston, MA, MRCP, PhD; Rick Spaide, MD; Brad Cunningham, MS; Michael Abramoff, MD, PhD; Donald Hood, PhD

    11:30 a.m.

    Lunch/Exhibit Hall


    Session 2: Adaptive Optics (AO)

    12:30 p.m.

    Adaptive Optics introduction and use in imaging devices: Alfredo Dubra, PhD

    12:40 p.m.

    Clinical uses of Adaptive Optics: Jacque Duncan, MD

    12:50 p.m.

    Summary of research applications and how these may lead to clinical trials: Austin Roorda, PhD

    1:05 p.m.

    Regulatory considerations for Adaptive Optics Technology: Larry Kagemann, PhD

    1:15 p.m.

    Panel Discussion (Question 2)
    Moderator: Cathy Cukras, MD, PhD
    Panelists: Richard Rosen, MD; Jessica Morgan, PhD; Ron Schuchard, PhD; Laurent Vabre, PhD

    1:45 p.m.

    Break/Exhibit Hall


    Session 3: Nonclinical Data Sources

    2 p.m.

    Synthetic datasets (Phantom, Images) and their utility: Daniel Hammer, PhD

    2:20 p.m.

    Principles of the Medical Device Development Tool program: Ron Schuchard, PhD

    2:30 p.m.

    Panel Discussion (Question 3)
    Moderator: Natalie Afshari, MD, FACS
    Panelists: Joseph Carroll, PhD; Alfredo Dubra, PhD; Daniel Hammer, PhD; Vivek Srinivasan, PhD

    3 p.m.

    Break/Exhibit Hall


    Session 4: Reimbursement

    3:15 p.m.

    Reimbursement considerations, include coding and coverage (government and commercial payers): Michael Repka, MD

    3:30 p.m.

    CDRH Payer Program: Rochelle Fink, MD, JD

    3:40 p.m.

    Panel Discussion (Question 4)
    Moderator: Michael Repka, MD
    Panelists: David Glasser, MD; Allison Shuren, MSN; Laurence Clark, MD; Cindie Mattox, MD; Chris Quinn, OD; TBD

    4:30 p.m.

    Closing remarks