Ophthalmos receives FDA clearance for revolutionary lens free Ophthalmoscope, The Optyse™

Cambridge/ UK-based Ophthalmos Limited, specialists in the design, development and marketing of medical devices for use in ophthalmoscopy, has received Food and Drug Administration (FDA) 510(k) clearance to market its OptyseTM Lens Free Ophthalmoscope in the United States of America.

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 including 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.

Unique in its simplicity, the lens free technology eliminates the need to calibrate the ophthalmoscope prior to use, providing an immediate and clear view of the retina. Ease of use is further enhanced by the patented technology that minimises glare from the light source and the lens free viewing hole that eliminates interference that could otherwise result from dust or scratches on lenses.

“As the Optyse™ is pen-sized it is easy for practitioners to carry on their person so they can incorporate direct ophthalmoscopy into their routine work” commented the inventor, Roger Armour. “This is especially true for general practitioners, nurses, paramedics, medical students and those professionals working in the field or in remote locations”.
Laura Garcia, CEO of Ophthalmos commented: “Receiving our first marketing clearance by the USA FDA is a major milestone for the company. We are excited by the market opportunities in the United States 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.”
Laura continued: “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.”

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Notes to editors

About Ophthalmos
Ophthalmos Limited designs, manufactures and markets medical devices for use in ophthalmoscopy, promoting the use of eye health in general medical practice through the provision of revolutionary products. Roger Armour’s Lens Free Technology was the overall winner and winner of Best Innovation to Improve Global Healthcare at the Medical Futures Innovation Awards 2003, was a finalist in the 2006 Saatchi and Saatchi Awards Ceremony for World Changing Product, and received the prestigious Edward De Bono Award for Lateral Thinking (2006).

For further information please contact Laura J Garcia, CEO on +44 (0) 1799 532 777 or email laura.garcia@ophthalmos.co.uk.

External PR Agency: Black Pig
Account Manager: Anna Plant
Telephone: +44 (0) 1763 222 333 Email: anna.plant@blackpig.co.uk