iCare USA Receives FDA 510(k) Clearance for Eidon Ultra-Widefield Lens Module

iCare USA has received FDA 510 (k) clearance for the Eidon Ultra-Widefield Lens module. The Ultra-Widefield module enables the capture of 120˚ images of the retina in a single shot or up to 200˚ with its expanded ‘Mosaic’ function. Its high and sharp image quality enables the detection of small details and signs of pathologies from the center to the periphery, according to a company news release. 

The Ultra-Widefield Lens module can be retrofitted to most of the Eidon fundus imaging systems, enabling the acquisition of Ultra-Widefield infrared, autofluorescence, and fluorescein angiography images with an up to 200˚ panoramic view.

"The iCare Eidon platform set new standards in retinal imaging as the first TrueColor Confocal system to combine the best features of Scanning Laser Ophthalmoscopy (SLO) with those of standard fundus imaging. Now the iCare TrueColor Confocal Technology can be applied to Ultra-Widefield imaging expanding the Eidon platform’s image quality to an increased field of view on the retina," according to iCARE USA. "The early signs of retinal pathologies are often subtle and appear first on the periphery. A standard field lens is not enough to reveal these signs as it covers only a small portion of the retina. The Ultra-Widefield lens view enables Eidon diagnostics to surpass the limitations of conventional diagnostic equipment by revealing the condition of the periphery of the retina."

"Having access to this groundbreaking diagnostic imaging technology enables us to easily view critical peripheral retinal pathology in true to life color," Atul Jain, MD, of Retinal Specialists San Diego, said in a company news release. "For the first time we can show patients and document pathology in the peripheral retina just as it appears to us through the indirect ophthalmoscope."

For additional information on the expanded Eidon platform, visit: https://www.icare-world.com/uwfl/