Article

Hyperopia clinical module submitted to FDA

Fremont, CA-Nidek Inc. has submitted its hyperopia PMA clinical module to the FDA for review and approval of its EC-5000 Excimer Laser System for hyperopia, hyperopic astigmatism, and mixed astigmatism. This marks the final step in gaining commercialization approval by the FDA to market and treat indications of hyperopia with the Nidek system.

Newsletter

Don’t miss out—get Ophthalmology Times updates on the latest clinical advancements and expert interviews, straight to your inbox.

Subscribe Now!
Related Videos
(Image credit: Ophthalmology Times) NeuroOp Guru: Using OCT to forecast outcomes in ethambutol optic neuropathy
(Image credit: Ophthalmology Times) Inside NYEE’s new refractive solutions center with Kira Manusis, MD
(Image credit: Ophthalmology Times) Dilsher Dhoot, MD, on the evolution of geographic atrophy therapy: where are we now?
(Image credit: Ophthalmology Times Europe) Anat Loewenstein, MD, shares insights on the real-world results of remote retinal imaging
(Image credit: Ophthalmology Times) Two-wavelength autofluorescence for macular xanthophyll carotenoids with Christine Curcio, PhD
(Image credit: Ophthalmology Times) FLIO and the brain: Making the invisible visible with Robert Sergott, MD
(Image credit: Ophthalmology Times) Structure-function correlates using high-res OCT images with Karl Csaky, MD, PhD
(Image credit: Ophthalmology Times) SriniVas Sadda, MD, on high-res OCT of atrophic and precursor lesions in AMD
(Image credit: Ophthalmology Times) Christine Curcio, PhD, shares histology update supporting review software and revised nomenclature for <3 μm OCT
Related Content
RetinalGenix Technologies and LabCorp partner on DNA/RNA/GPS Pharmaco-Genetic Mapping platform
July 2nd 2025

RetinalGenix Technologies and LabCorp partner on DNA/RNA/GPS Pharmaco-Genetic Mapping platform

3 Things You Should Know About the GA Pipeline
June 4th 2025

3 Things You Should Know About Interventional Glaucoma Comanagement

(Image credit: AdobeStock/Vitalii Vodolazskyi) Yale researchers identify corneal ulcer pathogens by testing tears
July 1st 2025

Yale researchers identify corneal ulcer pathogens by testing tears

Patient-Centered Treatment Strategies in the Management of nAMD and DME
May 30th 2025

Patient-Centered Treatment Strategies in the Management of nAMD and DME

HLB Therapeutics misses primary end point in phase 3 SEER-3 trial of RGN-259
July 1st 2025

HLB Therapeutics misses primary end point in phase 3 SEER-3 trial of RGN-259

Nicox completes phase 3 Denali trial of NCX 470 in open-angle glaucoma or ocular hypertension
June 30th 2025

Nicox completes phase 3 Denali trial of NCX 470 in open-angle glaucoma or ocular hypertension

© 2025 MJH Life Sciences

All rights reserved.