CE Mark For RAPDx® Pupillograph Device Brings New Level Of Diagnostic Test

In short

Konan Medical USA, Inc. has announced that its RAPDx® pupillograph for screening of defects in pupil function has received the European CE Mark. The company will begin shipping product to Europe and other countries recognising the CE Mark to coincide with its appearance at the September 2012 European Society of Cataract and Refractive Surgeons (SCRS) meeting in Milan, Italy.


The so-called “pupil light reflex” is an objective indicator of specific function from the retina and optic nerve. A normal reflex, comparing left and right eyes is symmetric, however asymmetry (“RAPD” or “Relative Afferent Pupillary Defect”) can be a useful method to detect asymmetric diseases of the retina or optic nerve.

RAPDx records a high-definition, biometric waveform of the pupil responses, the “RAPDx Signature™”, which characterises key features of pupil defect responses beyond those seen by human observers of the old Swinging Flashlight Test.

Company comments

“We are pleased to be able to start offering our new RAPDx pupil diagnostic product to our European customers,” said Charles Wm. Stewart, OD, CEO of Konan Medical USA. “With inquiries from every major European market, RAPDx is being acknowledged as filling an important niche for physicians by enhancing the assessment of pupillary defects, one of the only components of routine eye examinations that has never received a technological enhancement.”

“Konan is pleased to add a new segment to our diagnostic imaging portfolio for Ophthalmology and Optometry,” said Tetsuji Ikegami, Chairman of Konan Medical USA and CEO of Konan Inc. (Japan). “There is specific interest in this product for screening in the Japanese and other Asian markets.” Dale Sadlik, COO added, “the addition of CE Mark to our recent Japanese approval continues to add opportunity to our commercialization strategy.”

Source:Konan Medical USA, Inc., PR Web