Quality
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ISO 13485:2016 Certified
Eyenuk's quality management system has been independently audited to be compliant with ISO 13485:2016
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MDSAP
Eyenuk's quality management system has been successfully audited under the Medical Device Single Audit Program (MDSAP) and is compliant with regulations of US, Canada, Brazil, and Australia.
Regulatory
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FDA Clearance
Eyenuk's EyeArt® is the first US FDA cleared AI technology for autonomous detection of both more than mild and vision-threatening diabetic retinopathy.
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CE Marking
Eyenuk's EyeArt® AI Eye Screening System for Diabetic Retinopathy has CE marking and is approved for sale in the EU as a Class IIb medical device.
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Health Canada License
Eyenuk's EyeArt® AI Eye Screening System for Diabetic Retinopathy has Health Canada license as a Class 2 medical device.
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Other Regions
EyeArt is approved for sales is several other global markets and regions. Please contact us to know if EyeArt is approved for sale in your country.
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Other Products
EyeMark™, EyeApp™, EyeSeeAMD™, and EyeSeeGlaucoma™ are under active development and have not yet been cleared for sales in any region.
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FCOI Policy
You can download Eyenuk's Financial Conflict of Interest Policy for Research from this link.
Cybersecurity
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GDPR Compliant
Eyenuk is GDPR compliant. For any cybersecurity or privacy related questions or concerns, please contact: securityofficer@eyenuk.com