iCARE USA receives FDA approval for latest EIDON fundus imaging system

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iCare USA’s EIDON Ultra-Widefield Lens module has received FDA 510 (k) approval for distribution across the United States, the company announced Wednesday.

iCare USA’s EIDON Ultra-Widefield Lens module has received FDA 510 (k) approval for distribution across the United States, the company announced Wednesday.

The latest addition to iCare USA’s EIDON family of retinal imaging modalities, the Ultra-Widefield lens captures 120˚ images of the retina in a single shot, or up to 200˚ with an expanded ‘mosaic’ function.

A sharp and high image quality allows for the detection of smaller details and pathology signs from the center to the periphery.

The module can be retrofitted to the majority 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, according to a news release.

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, the company stated.

This technology can be applied to the Ultra-Widefield imaging, expanding the EIDON platform’s image quality to an increased field of view on the retina.

Compared to a standard field lens —which only covers a small portion of the retina and can overlook early signs of retinal pathologies — the Ultra-Widefield lens view enables EIDON diagnostics to reveal the condition of the periphery of the retina.

According to the company, image sharpness, better optical resolution, higher details, an easy-to-use interface, and patient-frendly features are designed to assist clinicians in delivering efficient care to patients.