Welch Allyn, a leading medical diagnostic device company that delivers pragmatic innovation at the point of care, and LKC Technologies, Inc., the worldwide leader in visual electrophysiology and inventor of the RETeval® DR diabetic retinopathy assessment device announced an exclusive distribution agreement.
Under the terms of the agreement, Welch Allyn will distribute the Welch Allyn branded RETeval DR to healthcare providers outside of the United States who are focused on diabetic patients who face increased risk of sight-threatening disease such as diabetic retinopathy.
The RETeval DR provides a simple, fast, accurate, and cost-effective way to screen for sight threatening diabetic retinopathy (DR) without leaving the primary care office—compared to the current standard of care which is referral to the ophthalmologist or optometrist for a retinal exam using direct and indirect ophthalmoscopy, and/or dilated or un-dilated color fundus photography.
RETeval is a handheld electrophysiology based functional screening device. In just a few minutes per patient, a health care provider can screen for sight-threatening DR and clinically significant macular edema (CSME). Within the study, the patient test time averaged 2.3 minutes per patient for both eyes and results were achieved on 99.1% of the patients tested.
Results from a multi-center diabetic retinopathy screening clinical trial validated that RETeval can test a diabetic population and assess 76% as healthy and be correct 99% of the time.
There is no dilation regardless of pupil size nor is the test affected by the presence of a cataract. RETeval produces an immediate result without any remote grading needed.
James Datovech, President of LKC Technologies, said, "We believe that there is an opportunity to make a real impact in the lives of diabetics around the world. LKC is extremely pleased to partner with Welch Allyn."
RETeval DR will be available from Welch Allyn in many countries outside of the U.S. in the first quarter of 2015. The RETeval Complete product, which is useful for a broader range of ocular diseases and conditions, will remain exclusive to LKC Technologies worldwide. The RETeval DR and RETeval Complete products are not yet available for clinical use in the U.S. RETeval is approved for sale and clinical use in Japan, Australia, Canada, and is CE marked.
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