The Aurora AEYE is the first FDA-approved handheld AI fundus camera.
Optomed (Helsinki, Finland) has announced that its handheld fundus camera, the Aurora AEYE, which is integrated with AEYE Health’s (Tel Aviv, Israel) artificial intelligence technology, has received FDA 510(k) clearance in the U.S.
This marks the first FDA-approved handheld AI screening device for diabetic retinopathy, a leading cause of vision loss in working-age adults.
Zack Dvey-Aharon, co-founder and CEO of AEYE Health, called the clearance “a true game-changer,” expressing excitement about bringing the Aurora AEYE system to clinical practice across the United States.
Optomed US announces the news on its LinkedIn page
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Key features and healthcare impact
The Optomed Aurora AEYE is a portable, internet-connected fundus camera designed for point-of-care diabetic retinopathy screening in diverse settings—from primary care clinics to patients’ homes.
Its quick, non-invasive process requires only one image per eye, delivering diagnostic results within 60 seconds. This user-friendly design enables clinicians to provide on-the-spot diagnoses, potentially expanding access to retinal screening in primary care.
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The system’s ease of use and rapid results help close critical diabetic eye care gaps, contributing to improved healthcare outcomes. Importantly, the technology benefits from a dedicated CPT reimbursement code (92229) for AI-based diabetic retinopathy screening in the US, supporting enhanced healthcare quality metrics such as HEDIS scores and Star ratings.
Proven diagnostic accuracy across devices
The AEYE-DS AI software powering Aurora AEYE is cleared for use with both the Optomed Aurora and Topcon NW400 cameras, giving clinicians flexibility to incorporate it within their existing workflows.
In FDA clinical studies focused on detecting more-than-mild diabetic retinopathy, AEYE-DS showed a sensitivity range of 92% to 93% and specificity between 89% and 94% using a single image per eye with the Optomed Aurora camera. When used with the Topcon NW400, sensitivity remained at 93% with specificity exceeding 91%, all while requiring just a single image per eye.*
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*Additional information on the pivotal prospective clinical trial can be found at ClinicalTrials.gov (NCT04612868)
Editor’s Note: For more information, please see Optomed USA’s official press release here.
This content is intended exclusively for healthcare professionals. It is not intended for the general public. Products or therapies discussed may not be registered or approved in all jurisdictions, including Singapore.