MacuLogix Receives CE Mark for AdaptDx
Direct sales in Europe for clinical use in the early detection of age-related macular degeneration (AMD) will begin in 2016
Hummelstown, Pa., September 22, 2015 – MacuLogix, Inc., a pioneer in the early detection and tracking of retinal diseases, today announced that it has completed the requirements for CE marking of the AdaptDx, the first instrument to provide a practical and objective measurement of dark adaptation function. Impaired dark adaptation is a sensitive, early marker of age-related macular degeneration (AMD) and other macular dystrophies. AdaptDx was formally registered for CE marking on July 30, 2015.
The CE Mark indicates that the AdaptDx, an AC-powered, automated adaptometer designed to evaluate the time for retinal adaptation to darkness after exposure to light, conforms with the safety and quality standards required for marketing a medical device in 33 participating European countries. AdaptDx is intended to be used as a diagnostic device to aid in the detection, monitoring and management of age-related macular degeneration (AMD) and for measurement of dark adaptation speed.
“A number of leading academic institutions across Europe are already using the AdaptDx as a research tool but the CE Mark allows us to begin commercializing it as a clinical device for patient care,” said John G. Edwards, CEO of MacuLogix. “The demographic wave of aging patients at risk for AMD is beginning to crest in Europe as it is here in the United States, and AdaptDx provides a unique tool for eye care professionals to screen their patients for early signs of this disease and monitor its progression.”
MacuLogix will initiate direct sales of AdaptDx in Europe during 2016.
MacuLogix, Inc. is a pioneer in the early detection and tracking of retinal diseases. The Company’s AdaptDx® is the first practical measurement tool for dark adaptation. Dark adaptation is known to be substantially impaired in degenerative diseases of the macula such as age-related macular degeneration (AMD) and inherited macular dystrophies. Based on significant technical advances, the AdaptDx provides doctors with an easy-to-use functional test for macular degeneration similar to routine perimetry testing for glaucoma.