August. 12, 2022

Completion of Declaration of Conformity

Findex Inc. ("FINDEX") announced today that its self-developed perimeter, "GAP" conformity studies for European Medical Device Regulation (MDR) have been completed and the company has issued its EU Declaration of Conformity on 12th of August. MDR is a new European Medical Device Regulation which came into effect in 2021, replacing the former European Directives for medical devices (MDD). It is intended to establish a sustainable regulatory framework for all medical devices in Europe to ensure a high level of safety and liability whilst supporting the transparency of medical markets. In accordance with the completion of the whole process, FINDEX starts its first global sales targeting the ophthalmologic institutions in EU countries. *

"GAP", which had complied with the stringent European standards, is an innovative objective perimeter, capable of collecting visual field data with the latest AI and eye tracking technologies. With this device there is no need for a patient to fix the eyes or to press the button as the visual field is automatically measured when the patient follows the stimulus with both eyes, which also eliminates the necessity for shielding one eye while testing another. Notably, this device is a head mounted display, that allows users to carry it around, and to administer the test outside the dark room. FINDEX will focus on sales of this product not only in Japan but also in the EU, Middle East and North African countries. The company will also accelerate the execution of the business plans to obtain regulatory approval in other regions, including Asia, to further strengthen overseas sales.

Glaucoma, which causes only a few subjective symptoms, is one of the main causes of blindness and is a visual field disorder, for which no radical treatment is available under the current medical practices. Early detection of glaucoma by testing is essential to halt its progression and avoid the risk of blindness. FINDEX will contribute to the early detection, progress tracking and treatment of glaucoma and other eye diseases, globally increasing the opportunities for taking perimetry tests through the promotion of its user-oriented perimeter.

* : Product name is subject to change depending on the conditions of the export destination.
  Selling prices also vary by region.