Cambridge company seals US approval
Cambridge based Opthalmos Limited, has received FDA approval to market its new lens-free opthalmoscope in the US.
The OptyseTM is a relatively low cost, easy to use direct ophthalmoscope designed to be used by a range of healthcare workers and medical students.
Direct ophthalmoscopy is an effective, non-invasive technique enabling medical practitioners to view the back of the eye for evidence of abnormalities indicative of serious medical conditions.
These include hypertension, diabetes, cerebral malaria and early signs of brain tumours, as well as eye conditions such as glaucoma and cataracts that can lead to loss of sight or even blindness.
The lens free technology eliminates the need to calibrate the ophthalmoscope prior to use, providing an immediate and clear view of the retina.
The patented technology also minimises glare from the light source while the lens free viewing hole eliminates interference that could otherwise result from dust or scratches on lenses.
CEO Laura Garcia said: “Receiving our first marketing clearance by the US FDA is a major milestone for the company. We are excited by the market opportunities in the US and the ability to broaden our work with charitable agencies based both within the States and abroad to help achieve the VISION 2020 goal of eliminating unnecessary blindness by 2020.
“We are in discussions with potential distribution partners, but are pleased that we may now begin to sell to healthcare workers in the United States.”