Irvine, California — October 10, 2025 — Leads & Copy — Konan Medical USA, Inc. announced today that its objectiveFIELD Analyzer (OFA®) has received CE Marking under the European Medical Device Regulation (MDR). This allows the company to offer advanced perimetry to healthcare providers across the European Union.
CE Marking signifies the device meets the European Union’s safety and performance requirements, ensuring it is reliable, effective, and safe for clinical use. The OFA is also available in the USA, Canada, Japan, and select international markets.
The OFA is a bilateral visual field analyzer that measures pupillary responses to spatially resolved stimuli, captured by video cameras. Retinal sensitivity is derived from the amplitude of the pupil responses, and OFA measures delay/latency, providing new information not available from other SAP devices. Reports are presented in a familiar format.
Simon Gordon, co-Chief Executive Officer of Konan Medical USA, Inc., stated that the CE Marking is a testament to the team’s dedication to innovation. The approval was granted after a rigorous assessment process, confirming the OFA conforms to the requirements of the MDR Regulation EU 2017/745.
Dale Sadlik, co-CEO, added that this approval is pivotal for expanding access to objective visual -function testing, augmenting current standard of care and enabling testing of patients too young for traditional subjective methods. The OFA is expected to be available to European hospitals and clinics starting in October 2025.
For more information about objectiveFIELD including 39 peer reviewed clinical and scientific publications please visit https://konanmedical.com/objectivefield/.
Contact:
Ian McMillan
VP of Sales and Marketing
imcmillan@KonanMedical.com
Source: Konan Medical USA, Inc.
