Clarity on some commonly asked questions.

The EyeArt system is FDA-cleared for use in adults who have been diagnosed with diabetes but have not been previously diagnosed with diabetic retinopathy. It is intended for use in frontline healthcare settings by trained professionals.

The EyeArt system is FDA-cleared for the autonomous detection of both more than mild and vision-threatening diabetic retinopathy in adults with diabetes. These thresholds provide clinicians the actionable data to prioritize referrals for high-risk patients.

Yes. In the US, CPT code 92229 supports point of care autonomous retinal imaging with an AI-generated report. This code has an established national Medicare price, and can help health systems offset implementation costs and support long-term program growth.

We recognize that every health system has a unique technical ecosystem. Eyenuk provides comprehensive collaboration to integrate EyeArt results into your specific electronic medical/health record (EMR/EHR) environment using industry-standard protocols. Our team partners with your IT and clinical leadership to navigate the nuances of your workflow, ensuring results are properly documented in the patient’s record and manual data entry is minimized. We have integrated with multiple major EHR systems, including EPIC, where EyeArt exams are directly ordered by providers in the EHR and after the screening, diagnostic results and reports are automatically documented in the EHR, and automated referrals are triggered (as required) based on the diagnostic result.

EyeArt is the first autonomous AI to receive FDA clearance for use with multiple camera models from different manufacturers. It is cleared for use with the Canon CR-2 AF, Canon CR-2 Plus AF, and Topcon NW400. This flexibility allows health systems to leverage existing hardware or choose the best fit for their clinics.

By performing diabetic eye screenings at the point of care in a primary care setting, health systems can significantly increase screening compliance rates. This proactive approach helps close critical care gaps, directly supporting improved HEDIS and Medicare Advantage Star Ratings.

No. EyeArt is an autonomous AI, meaning it provides a diagnostic result at the point of care without requiring an overread by an eyecare specialist. This allows primary care teams to relay the AI-generated findings and facilitate necessary specialist referrals during the patient’s routine diabetes checkup.

The AI analysis is nearly instantaneous. Once the retinal images are captured and uploaded, the system provides a result in under 10 seconds, enabling immediate clinical decision-making while the patient is still in the office.

The platform includes real-time image quality feedback. If a captured image does not meet the necessary quality threshold for a definitive analysis, the system immediately notifies the operator so they can retake the photo while the patient is still positioned at the camera.

No. Most patients (> 90%) can receive conclusive EyeArt results without the need for dilating drops, which improves patient comfort, reduces visit time, and simplifies the workflow for the primary care team.

Eyenuk maintains enterprise-grade security protocols, including HIPAA compliance and SOC 2 Type 2 attestation. All patient data is protected with high-level encryption both at rest and during transit to ensure the highest standards of data privacy.

Eyenuk provides a structured onboarding program for medical assistants and nursing staff. Since the AI provides real-time feedback on image quality, staff can be trained quickly to capture high-quality, gradable images, making the system easy to adopt in high-volume primary care settings.

Eyenuk was founded in 2010 by Dr. Kaushal Solanki, who led a multidisciplinary team of experts in artificial intelligence, medical imaging, and clinical research. Together, they developed the foundational deep-learning algorithms that became EyeArt, fueled by a shared mission to eliminate preventable blindness. The team’s unique combination of technological innovation and rigorous clinical validation was essential in creating a solution that addresses the global shortage of expert eye care for millions living with diabetes.