Konan Medical Receives CE Marking for ObjectiveFIELD Analyzer (OFA)

Konan Medical USA announced that its objectiveFIELD Analyzer (OFA) has received CE Marking under the European Medical Device Regulation (MDR). The CE Mark enables Konan Medical to offer its next-generation perimetry solution to healthcare providers throughout the European Union.

The objectiveFIELD system is also commercially available in the United States, Canada, Japan, and select international markets.

According to Konan, the OFA is the first objective, bilateral visual field analyzer. Instead of relying on subjective, button-press responses to small white light stimuli—as required in traditional Standard Automated Perimetry (SAP)—the OFA measures pupillary responses to spatially resolved visual stimuli under infra-red conditions. These responses are recorded by video cameras and analyzed to assess visual field abnormalities with precision and objectivity.

Retinal sensitivity is determined by the amplitude of pupil responses, while OFA also measures latency (time-to-peak constriction)—providing valuable new diagnostic information not available through SAP. Unlike SAP, which only detects reduced sensitivity defects (Half-Axis), OFA is a 'Dual-Axis' system, capable of identifying both reduced and high-sensitivity visual field changes without additional time or effort. Test results are presented in a familiar, easy-to-interpret report format for clinicians, according to Konan.

The CE Marking approval follows an extensive and rigorous MDR conformity assessment, validating the device’s compliance with EU Regulation 2017/745. This process included a thorough review of clinical data, technical documentation, and manufacturing processes. Konan Medical USA’s quality management system is certified to ISO 13485:2016 MDSAP.

The CE Marking approval paves the way for the OFA’s introduction to European hospitals and clinics beginning this month. With test protocols as fast as 90 seconds for both eyes and no need for patient interaction, OFA offers benefits in efficiency, patient comfort, and accessibility—particularly for pediatric patients or those unable to perform traditional perimetry tests.

“This approval is pivotal for expanding access to new, objective visual function testing, which we believe will augment the current standard of care,” said Dale Sadlik, Co-Chief Executive Officer of Konan Medical USA. “There is a great deal of interest from specialists focused on diabetic retinal disease and pediatric care, and we anticipate clinics will see improvements in both workflow and patient satisfaction.”