U.S. Food and Drug Administration recently issued the following announcement.
The Food and Drug Administration (FDA), American Academy of Ophthalmology (AAO), American Academy of Optometry (AAOPT), American Association for Pediatric Ophthalmology and Strabismus (AAPOS), American Glaucoma Society (AGS), American Optometric Association (AOA), American Society of Cataract and Refractive Surgeons (ASCRS), American Society of Retinal Surgeons (ASRS), American Uveitis Society (AUS), Byers Eye Institute at Stanford University (BEIS), Cornea Society, and the Retina Society) are announcing a public Workshop titled: Forum on Laser-Based Imaging. 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.
- Date: Monday, April 8, 2019
- Time: 8:00 a.m. to 4:30 p.m.
- Location: Tommy Douglas Conference Center - Silver Spring, MD
- Registration: http://www.cfom.info/meetings/LaserBasedImaging/index.html
- Contact Us: akurilla@cfom.info
This meeting will be held Monday, April 8, 2019, beginning at 8:00 a.m. – 4:30 p.m. at the following location:
Tommy Douglas Conference Center
10000 New Hampshire Ave
Silver Spring, MD
Link for location Information - https://www.tommydouglascenter.com
The meeting will be webcasted.
Agenda
| Time Subject Name of Speaker/ | ||
| 8:00 a.m. | Breakfast/Exhibit Hall | |
| 8:30 a.m. Welcome and Introductory Remarks: Malvina 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 | Mitchell Weikert, MD |
| 9:20 a.m. | Clinical standards for assessment of novel anterior segment measurements | Yasmin Bradfield, MD |
| 9:35 a.m. | Novel applications of leading-edge OCT in the diagnosis and treatment of glaucoma | Joel S. Schuman, MD, FACS |
| 9:50 a.m. | Novel applications of leading edge OCT in the diagnosis and treatment of retinal disease | Richard Spaide, MD |
| 10:05 a.m. | Clinical standards for assessment of novel posterior segment measurements for retinal disease and glaucoma | SriniVas R. Sadda, MD |
| 10:20 a.m. | Break/Exhibit Hall | |
| 10:35 a.m. | AI-assisted segmentation | Michael F. Chiang, MD |
| 10:50 a.m. | 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 | |
| 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 L. 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 I. W. Morgan, PhD; Ron Schuchard, PhD; Nicolas Chateau, PhD | |
| 1:45 p.m. | Break/Exhibit Hall | |
| Session 3: Nonclinical Data Sources | ||
| 2:00 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 A. Afshari, MD Panelists: Joseph Carroll, PhD; Alfredo Dubra, PhD; Daniel Hammer, PhD; Vivek Srinivasan, PhD | |
| 3:00 p.m. | Break/Exhibit Hall | |
| Session 4: Reimbursement | ||
| 3:15 p.m. | Reimbursement considerations, include coding and coverage (government and commercial payors) | Michael X. Repka, MD, MBA |
| 3:30 p.m. | CDRH Payer Program | Rochelle Fink, MD, JD |
| 3:40 p.m. | 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 | |
| 4:30 p.m. | Closing remarks | |
Registration to Attend the Workshop
Registration is $295 (in-person) and $275 (webcast) for members of the American Academy of Ophthalmology (AAO), American Academy of Optometry (AAOPT), American Association for Pediatric Ophthalmology and Strabismus (AAPOS), American Glaucoma Society (AGS), American Optometric Association (AOA), American Society of Cataract and Refractive Surgeons (ASCRS), American Society of Retinal Surgeons (ASRS), American Uveitis Society (AUS), Cornea Society, the Retina Society, and Stanford Medicine, Byers Eye Institute; and $445 (in-person) and $425 (webcast) for non-members and available on a first-come, first-served basis. Persons interested in attending this workshop must register online. The deadline for online registration is Wednesday, March 27, 2019. There will be no onsite registration on the day of the public workshop. Early registration is recommended because facilities are limited.
To register for the public workshop, please visit Forum on Laser-Based Imaging. Please provide complete contact information for each attendee, including name, title, affiliation, address, email, telephone number, and membership in the cosponsoring organizations. If there are any questions with registration, please contact Bobbi Hahn, Program Manager, Center for Organizational Management, 2025 Woodlane Drive, St. Paul, Minnesota 55125, 651-731-7238, E-mail: akurilla@cfom.info Registrants will receive confirmation after they have been accepted. You will be notified if you are on a waiting list.
If you require special accommodations due to a disability, please contact Susan Monahan, Office of Communications, Education, and Radiation Programs, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 32, Silver Spring, MD 20993, 301-796-5661, susan.monahan@fda.hhs.gov.
Contact Us
For questions regarding workshop content please contact:
Maritze Ortega, Project Manager, Division of Ophthalmic and Ear, Nose, and Throat Devices (DOED), Office of Device Evaluation (ODE), Center for Devices and Radiological Health (CDRH), Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 66, Rm 2426, Silver Spring, MD 20993, 301-796-5625, email: maritze.ortega@fda.hhs.gov.
Original source can be found here.
