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

Newsletter

Join ophthalmologists across Europe—sign up for exclusive updates and innovations in surgical techniques and clinical care.

Recent Videos
Christine Curcio, PhD, of the University of Alabama at Birmingham Heersink School of Medicine, shares histology update and revised nomenclature for OCT with Sheryl Stevenson of the Eye Care Network and Ophthalmology Times
SriniVas R. Sadda, MD, FARVO, shares key points from his retina presentation at the International SPECTRALIS Symposium
Robert Sergott, MD, describes fluorescence lifetime imaging ophthalmoscopy (FLIO) and the International SPECTRALIS Symposium – And Beyond (ISS) in Heidelberg, Germany.
Rayaz Malik, MBChB, PhD, a professor of medicine at Weill Cornell Medicine - Qatar, spoke with Ophthalmology Times Europe about his presentation. It's titled "An eye on neurodegenerative diseases: Challenging the dogma" at the International SPECTRALIS Sympsoium. In conversation with Hattie Hayes, Ophthalmology Times Europe
Anat Loewenstein, MD, describes her presentation on remote imaging for age-related macular degeneration and geographic atrophy at the International SPECTRALIS Symposium, in conversation with Hattie Hayes of Ophthalmology Times Europe
Tyson Brunstetter, OD, PhD, a US Navy Aerospace Optometrist at the NASA Johnson Space Center in Houston, Texas, shares key takeaways from his keynote at the International SPECTRALIS Symposium (ISS)
Rayaz Malik, MBChB, PhD, shares his presentation, titled An eye on neurodegenerative diseases: Challenging the dogma, at this year's International SPECTRALIS Symposium
At the Retina World Congress, Siegfried Priglinger, MD, speaks about ensuring the best outcomes for preschool-aged patients
At the 2025 ASCRS meeting, Robert Ang, MD said small aperture IOLs can benefit all patients, especially those with complex corneas or who have undergone previous corneal refractive surgery
Viha Vig, MBChB graduate student at the University of Auckland, New Zealand, discusses her poster presentation on the relationship between mitochondiral disease, Alzheimer disease, and other types of dementia.
Related Content
© 2025 MJH Life Sciences

All rights reserved.