Konan Medical’s objectiveFIELD® Perimeter Gains CE Mark certification in Europe
Konan Medical has announced that its objectiveFIELD® Analyzer (OFA®) has received CE Mark certification under the European Medical Device Regulation (MDR), paving the way for clinical use across the European Union.
The approval marks a major milestone for the company, allowing it to expand access to its objective perimetry technology, which eliminates the need for traditional, subjective patient responses during visual field testing.
Already cleared by the FDA and available in the United States, Canada, Japan, and select international markets, the OFA becomes the first and only truly objective perimeter to receive regulatory approval in both the US and EU.
Unlike standard automated perimetry (SAP), which requires patients to press a button in response to visual stimuli, OFA uses infrared video cameras to record pupillary responses to spatially resolved visual stimuli. These involuntary reactions provide a direct, objective measure of visual function.
The device captures two key parameters: Retinal sensitivity, derived from the amplitude of pupil responses, and Latency (time-to-peak constriction), offering insight into neural conduction delays — data unavailable from traditional SAP devices.
Konan’s Dual-Axis analysis also detects both reduced and abnormally high sensitivity defects, expanding diagnostic capability without increasing test time. With test protocols as short as 90 seconds for both eyes, OFA is designed to improve workflow efficiency and patient comfort, particularly in populations unable to perform subjective testing, such as children and patients with cognitive impairment.
"We are thrilled to have achieved CE Marking for the OFA. It is a testament to our team's dedication to innovation and developing novel medical technology,” said Simon Gordon, co-CEO of the company.
Co-CEO Dale Sadlik added: “This approval is pivotal for expanding access to new, objective visual -function testing, which we believe will augment current standard of care and enable testing patients that are too young for traditional subjective methods. There is a great deal of initial interest from specialists that are focused on diabetic retinal disease (DRD) and pediatrics.”
European rollout of the OFA is expected to begin later this month.
Konan Medical has announced that its objectiveFIELD® Analyzer (OFA®) has received CE Mark certification under the European Medical Device Regulation (MDR), paving the way for clinical use across the European Union.
The approval marks a major milestone for the company, allowing it to expand access to its objective perimetry technology, which eliminates the need for traditional, subjective patient responses during visual field testing.
Already cleared by the FDA and available in the United States, Canada, Japan, and select international markets, the OFA becomes the first and only truly objective perimeter to receive regulatory approval in both the US and EU.
Unlike standard automated perimetry (SAP), which requires patients to press a button in response to visual stimuli, OFA uses infrared video cameras to record pupillary responses to spatially resolved visual stimuli. These involuntary reactions provide a direct, objective measure of visual function.
The device captures two key parameters: Retinal sensitivity, derived from the amplitude of pupil responses, and Latency (time-to-peak constriction), offering insight into neural conduction delays — data unavailable from traditional SAP devices.
Konan’s Dual-Axis analysis also detects both reduced and abnormally high sensitivity defects, expanding diagnostic capability without increasing test time. With test protocols as short as 90 seconds for both eyes, OFA is designed to improve workflow efficiency and patient comfort, particularly in populations unable to perform subjective testing, such as children and patients with cognitive impairment.
"We are thrilled to have achieved CE Marking for the OFA. It is a testament to our team's dedication to innovation and developing novel medical technology,” said Simon Gordon, co-CEO of the company.
Co-CEO Dale Sadlik added: “This approval is pivotal for expanding access to new, objective visual -function testing, which we believe will augment current standard of care and enable testing patients that are too young for traditional subjective methods. There is a great deal of initial interest from specialists that are focused on diabetic retinal disease (DRD) and pediatrics.”
European rollout of the OFA is expected to begin later this month.
