iCare USA’s EIDON Ultra-Widefield Lens module receives US FDA 510(k) approval

Article

The EIDON Ultra-Widefield Lens module from iCare USA has received 510(k) approval from the FDA for distribution in the US.

iCare USA’s EIDON Ultra-Widefield Lens module receives US FDA 510(k) approval

The EIDON Ultra-Widefield Lens module from iCare USA has received 510(k) approval from the FDA for distribution in the US.

The Ultra-Widefield lens enables infrared, autofluorescence and fluorescein angiography images with up to 200° panoramic view. The lens captures 120 degree images of the retina in a single shot or up to 200 degrees with the “Mosiac” feature. This shows small details, highlighting signs of pathology from the center to the periphery and enables EIDON diagnostics to surpass limitations of conventional diagnostic tools.

The EIDON from iCare is the first TrueColor Confocal system to combine standard fundus imaging with features of Scanning Laser Ophthalmoscopy (SLO) systems. The retinal imaging system provides widefield views in multiple imaging modalities.

The Ultra-Widefield lens can be retrofitted to most of the EIDON fundus imaging systems.

iCare offers clinicians ophthalmic diagnostic tools to detect glaucoma, diabetic retinopathy and age-related macular degeneration (AMD). Their portfolio includes automated TrueColor imaging devices, perimeters and handheld rebound tonometers.

More information about the EIDON Ultra-Widefield lens can be found on the iCare website.

Related Content: Gene Therapy | Retina | Cataract & Refractive

Recent Videos
Anat Loewenstein, MD, speaks about the 22nd Annual Angiogenesis, Exudation, and Degeneration Meeting in February 2025 and shares her global forecast for AI-driven home OCT
Sarah M. Thomasy, DVM, PhD, DACVO, a veterinary ophthalmologist at UC Davis, talks about how her research at the Glaucoma 360 symposium
I. Paul Singh, MD, an anterior segment and glaucoma specialist, discusses the Glaucoma 360 conference, where he participated in a panel discussion on the use of artificial intelligence (AI) in glaucoma care.
Charles Wykoff, MD, PhD, discusses his Floretina ICOOR presentation topic, retinal non-perfusion in diabetic retinopathy, with David Hutton, editor of Ophthalmology Times
Elizabeth Cohen, MD, discusses the Zoster Eye Disease study at the 2024 AAO meeting
Victoria L Tseng, MD, PhD, professor of ophthalmology and glaucoma specialist, UCLA
Brent Kramer, MD, of Vance Thompson Vision speaks at the 2024 AAO meeting
© 2025 MJH Life Sciences

All rights reserved.