EasyScan smart retinal imaging gets FDA clearance
Good news for millions of diabetes patients in the USA
i-Optics is happy to announce that its smart retinal imaging system EasyScan has been 510(k) cleared by the United States Food and Drug Administration (FDA). EasyScan is a highly innovative retinal imaging solution from i-Optics, a specialist eye diagnostics company that pioneers innovative retina and cornea imaging systems.
EasyScan offers a number of benefits over traditional fundus cameras: it is fast, easy-to-use, patient friendly and accessible. The EasyScan is a truly zero-dilation system, making it the most patient-friendly retinal imaging system on the market. Weighing less than 7kg and with a footprint smaller than a binder, EasyScan is extremely portable – which means imaging can be brought closer to the patient. It consumes little power and it connects to a PC or laptop via a standard USB connection. This is good news for patients: Early diagnosis and timely treatment are crucial to preventing blindness among the more than 25 million diabetes sufferers in the USA. “With aging populations and growing obesity, countries everywhere face a rapid increase in diabetic retinopathy, age-related macular degeneration, glaucoma, and other retinal diseases,” said Jeroen Cammeraat, CEO at i-Optics. “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.”
EasyScan is based on confocal Scanning Laser Ophthalmoscope (SLO) technology, which brings out clinical features in the retina in the earliest stages, provides better contrast than fundus cameras, and can better penetrate media opacities such as cataract and corneal opacities. It can image through pupils as small as 2mm, removing the need for pupil dilation, and reducing the patient’s waiting time by at least 30 minutes. Patients can also drive home immediately after being examined, contrary to most fundus cameras where pupil dilation results in a blurred vision for many hours after the exam. Time-saving benefits for health care professionals include live image previewing, self-guiding software that eliminates the multitude of settings and controls required by fundus cameras, and automatic focusing. “Add in a full digital workflow for storing, retrieving, archiving and sharing images instantly, and immediate plug-and-play connectivity, and EasyScan truly can be used by anyone, anywhere,” said Jeroen Cammeraat.
Cammeraat further comments, “i-Optics’ EasyScan offers US customers the capability to access user friendly and affordable retinal imaging technology. The EasyScan is ideal for diagnosis and progress monitoring of Diabetic Retinopathy, Age-related Macular Degeneration (AMD) and Glaucoma. We are excited about the opportunity to serve the US market as of today and following-up on our successful introduction earlier in October at the American Academy of Optometry in Boston and the American Academy of Ophthalmology in Orlando.“
