Butchertown Clinical Trials and The Eye Care Institute Announce Our 16th FDA Approval
AEye Health receives FDA Clearance for the detection of more than mild to moderate diabetic retinopathy ; A first for our Clinical Trials Program
AEye Health, a Tel Aviv biotechnology firm, received FDA clearance for use of the AEYE-DS tool for the detection of more-than-mild diabetic retinopathy with the Topcon NW400 camera
Company co-founder Dr. Zach Dvey-Aharon said “with the help of early detection of diseases, especially complications of diabetes, it is possible to stop the progression of the disease, but if the patient is already suffering from vision problems it is already too late because it means the brain has exhausted the tricks to bypass the problem. Early detection allows almost complete prevention of blindness and this is done by laser and injections of drugs into the eye. Our company developed artificial intelligence software that integrates into retinal scanning systems and we can have diagnostic answers returned within minutes.”
Butchertown Clinical Trials, of Louisville, KY was the primary clinical trials site in the US. Frances Weinstock, MD, a family practice physician, worked with Butchertown Clinical Trials as the Principal Investigator.
This is the 16th FDA-approved drug or device for Louisville, KY-based Butchertown Clinical Trials, a division of The Eye Care Institute. Mark Prussian, CEO, stated this device is considered a Class II medical device, for which the FDA grants the status of Cleared, rather than Approved. The previous 15 successes for Butchertown Clinical Trials have received FDA approval, however, as this is an artificial intelligence tool associated with an already FDA-approved medical device (the Topcon NW-400 retinal scanning camera) the term Cleared is appropriate.
Prussian continued this is the first Artificial Intelligence trial for Butchertown Clinical Trials and its first FDA approval or clearance with a family practice physician as Principal Investigator.
Butchertown Clinical Trials operates in a dedicated clinical trials center on an almost 6 acre healthcare campus and has completed over 450 clinical trials. The company is currently conducting 31 trials sponsored by pharmaceutical and medical device companies.
For further information, please contact:
Business Contact
Butchertown Clinical Trials
Mark Prussian
205 N. Spring Street
Louisville, KY 40206
502-219-7700
Office open Mon-Fri, 8am-5pm
