The Visual Evoked Potential Technology (VEP) behind the Enfant® was originally developed in 1983 by the Rockefeller University Laboratory of Biophysics. This breakthrough technology was licensed to NeuroScientific Corporation, which in 1986 merged with Neurotech Corporation, a small publicly traded company. At Neurotech, the VEP technology was updated and enhanced. The first systems created were the Venus and the Enfant®. Both systems were sold worldwide to large research institutions, teaching universities, and large clinical practices. Many of these systems remain in use today.
Diopsys, Inc. acquired the rights to the VEP technology in 1998. Upon completing additional engineering work, a new prototype of the Enfant® was developed, making it a functionally enhanced, easy-to-use version of the original systems.
In 2002, Phase IV clinical trials, conducted by leading pediatric ophthalmologists, were completed at five leading eye care medical centers. Also in 2002, Diopsys received patents covering process methodology and software for visual diagnostic testing utilizing fault detection, and a proprietary method for synchronizing VEP rates with stimulus.
After extensive on-site testing in 2003, the Enfant® was officially launched at the October 2004 annual meeting of the American Academy of Pediatrics. The Enfant® Pediatric VEP Vision Testing System is now available for pediatric practices nationwide.
During the nearly seven years of successful eye screening tests for children, Diopsys has continued an intensive product development program for VEP vision testing medical devices. The outcome of these efforts is the Diopsys® NOVA-VEP Vision Testing Systems product line. Through the combined expertise of professionals in the neurophysiology and ophthalmic fields and the extensive scientific and engineering know-how of Diopsys, this breakthrough technology can now be brought to community and office based practices. Diopsys introduced the NOVA product series in 2007 for use by the eye care professional. While the Enfant® is intended to be used by primary care physicians for vision testing and screening, the Diopsys® NOVA series was developed to provide an objective diagnostic and tracking modality for optometrists and ophthalmologists.
The Enfant® and Diopsys® NOVA-VEP Vision Testing Systems have US FDA 510k clearance. In addition, Diopsys vision testing systems have been assessed and certified as meeting the requirements of Directive 93/42/EEC and ISO 13485:2003 for the design and manufacture of non-invasive diagnostic vision testing equipment and carry the CE mark allowing sales of its devices in the European Union (EU).