PRWEB.COM NewswirePadova, Italy; Pasadena, CA, USA (PRWEB) January 05, 2015
Si14, an original design and technology development laboratory, announced today that its innovative D-EYE Portable Retinal Imaging System, a phone-case-sized add-on that turns an iPhone or Android smartphone into a fundus camera capable of taking high-definition video and still images of the eye for health screening and evaluation, is now registered with both the United States Food and Drug Administration and the European CE authority.
The company received US FDA Class 510(K) exempt listing number D231842 on Dec. 19, 2014, and CE Class 1 device registration number 1243284 on Dec. 20, 2014. With CE and FDA registrations, the company is now authorized to sell the D-EYE product in the European Union and the United States. In conjunction with the announcement of these registrations, Si14 stated that it expects to begin shipping the D-EYE Portable Retinal Imaging System in April, 2015.
“We are delighted to receive these FDA and CE registrations, and excited to be able to bring the early diagnosis benefits of D-EYE to patients in the US and Europe,” according to D-EYE CEO Richard Sill. “The D-EYE retinal screening system can be used in any setting by a variety of health professionals ranging from ophthalmologists, optometrists, neurologists, general practitioners, emergency physicians and pediatricians to school nurses, EMTs, and others. The system offers a quick, accurate and inexpensive way to examine the human eye and identify a variety of health conditions, including the leading causes of blindness: glaucoma, diabetic retinopathy and macular degeneration.”
D-EYE is the result of ground-breaking work done by Dr. Andrea Russo, who partnered with Si14 in the development of the device. An ophthalmologist and Ph.D.-candidate researcher with the University of Brescia, Italy, Dr. Russo invented the D-EYE to improve access to vital medical screenings for people in need.
Source: Digital Journal