Featured clinical research.
Review the multi-center clinical trials and peer-reviewed studies that support our technology’s performance in diverse healthcare settings.
See all of our clinical studies.
FDA-cleared AI for Diabetic Retinopathy Detection.
Eyenuk’s EyeArt system is clinically validated and regulatory-approved for autonomous detection of more than mild and vision-threatening diabetic retinopathy.
Regulatory clearances.
Our system meets the specific performance and safety requirements of major governing bodies.
US FDA 510(k) clearance
since
2020
EyeArt is the first US FDA cleared AI technology for autonomous detection of both more than mild and vision-threatening diabetic retinopathy.
CE Marking under EU MDR
since
2015
EyeArt is the first Class IIb certified AI technology for the autonomous detection of diabetic retinopathy (DR), age-related macular degeneration (AMD), and glaucomatous optic nerve damage.
Health Canada Class II license
since
2018
EyeArt has a Health Canada license as a class II medical device for autonomous detection of diabetic retinopathy.
Colombia INVIMA certification
since
2020
EyeArt has an INVIMA sanitary registration for the autonomous detection of diabetic retinopathy (DR), age-related macular degeneration (AMD), and glaucomatous optic nerve damage.
Ecuador ARCSA approval
since
2026
EyeArt has ARCSA Health Registration Certificate for the autonomous detection of diabetic retinopathy (DR), age-related macular degeneration (AMD), and glaucomatous optic nerve damage.
Quality and Security certifications.
We maintain compliance with recognized international standards to ensure manufacturing quality and the protection of patient data.
FDA Establishment Registration and Device Listing
since
2020
EyeArt is an officially classified diabetic retinopathy detection device.
California Food and Drug Board Device Manufacturing License
since
2019
Eyenuk is a California-licensed medical device manufacturer, ensuring the EyeArt system meets all state and federal regulatory and quality standards.
ISO 13485:2016 certified
since
2015
Eyenuk's Quality Management System is ISO 13485:2016 certified, meeting global standards for medical device quality.
MDSAP certified
since
2018
Eyenuk's Quality Management System is MDSAP certified, meeting the regulatory requirements of the US, Canada, Japan, Australia, and Brazil (Medical Device Single Audit Program).
SOC 2 Type 2 attested
since
2024
Eyenuk has successfully completed an independent SOC 2 Type 2 + HIPAA audit by Prescient Assurance. This attestation confirms our compliance across all Trust Service Criteria: Security, Availability, Processing Integrity, Confidentiality, and Privacy.
HIPAA compliant
since
2018
Eyenuk has been independently audited by A-Lign to be compliant with HIPAA privacy and security controls.
GDPR compliant
Eyenuk is compliant with EU and General Data Protection Regulation (GDPR). For any cybersecurity or privacy-related inquiries, please contact securityofficer@eyenuk.com.
UK Cyber Essentials certified
since
2026
Eyenuk has achieved the UK Cyber Essentials certification, validating that its products and processes meet rigorous, government-backed cybersecurity standards.
Cleared for use with leading retinal cameras.
EyeArt is the first autonomous system cleared by the FDA for use with multiple camera models from different manufacturers, allowing for flexible integration into existing clinical workflows.
Why this matters clinically.
Rigorous validation and regulatory clearances enable seamless scalability across any health system. This adaptability allows autonomous screening with existing primary care and other workflows, closing care gaps without specialized staffing and providing the clinical trust needed to prevent vision loss.
Peer-reviewed clinical validation.
Clinically-proven in large-scale studies.
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Transform every eye into a gateway to understanding.
Start FDA-cleared autonomous diabetic retinopathy screening in your clinic today.