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i-Optics retinal imager gets FDA clearance
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The EasyScan zero-dilation retinal imaging system by i-Optics has been granted 510(k) clearance from the U.S. Food and Drug Administration, according to a company press release.
"With aging populations and growing obesity, countries everywhere face a rapid increase in diabetic retinopathy, age-related macular degeneration, glaucoma and other retinal diseases," Jeroen Cammeraat, i-Optics CEO, said in the release. "Unfortunately, the traditional fundus cameras used to diagnose these conditions are large, exclusive and expensive, as well as being slow and difficult to use. EasyScan has been designed from the ground up to solve all these problems."
The device uses confocal scanning laser ophthalmoscope technology, which can provide greater contrast than fundus cameras and can penetrate cataract and corneal opacities, according to the release.
Because the imaging system can work with pupils as small as 2 mm, there is no need for pupil dilation, reducing wait times and enabling patients to drive home immediately after being examined.
The portable machine, which weighs less than 7 kg, gives ophthalmologists access to live image previewing, automatic focusing and self-guiding software, according to the release.