Quality
ISO 13485:2016 Certified
Eyenuk's quality management system has been independently audited to be compliant with ISO 13485:2016
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
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.
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.
Health Canada License
Eyenuk's EyeArt® AI Eye Screening System for Diabetic Retinopathy has Health Canada license as a Class 2 medical device.
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.
Other Products
EyeMark™, EyeApp™, EyeSeeAMD™, and EyeSeeGlaucoma™ are under active development and have not yet been cleared for sales in any region.
FCOI Policy
You can download Eyenuk's Financial Conflict of Interest Policy for Research from this link.
Cybersecurity
HIPAA Compliant
Eyenuk has been independently audited by Prescient to be compliant with SOC2 Type II + HIPAA for Privacy, Security, Confidentiality, Processing Integrity, and Availability Trust Service Criteria.
GDPR Compliant
Eyenuk is GDPR compliant. For any cybersecurity or privacy related questions or concerns, please contact: securityofficer@eyenuk.com