Optomed USA has launched Optomed Aurora AEYE, a handheld AI fundus camera designed to instantly detect more than mild diabetic retinopathy.

Developed in collaboration with AEYE Health, the device enables on-the-spot eye screenings for diabetic patients in primary care settings, before being referred to an eye care professional.

The Optomed Aurora AEYE claims to have a user-friendly design and simplify the screening process, requiring only one image per eye and delivering results within 60 seconds.

The Optomed Aurora with AEYE-DS is claimed to be the only FDA-cleared handheld AI fundus camera of its kind.

Optomed USA managing director David Frasch said: “The Optomed Aurora AEYE gives primary care providers the opportunity to bridge the diabetic retinopathy gap in the US with immediate, on-the-spot detection of diabetic retinopathy with results in about 60 seconds.

“This technology removes the guesswork out of when it is necessary to refer a patient to an eye care provider. Results with the Optomed Aurora AEYE are simple: red means you refer to an eye care specialist and green means you screen again in 12 months.”

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Recent clinical trials have shown that the new camera has a diagnostic sensitivity between 92% and 93%, and a specificity between 89% and 94%. More than 99% of patients claimed to have received a diagnostic result during the two trials.

The camera’s non-mydriatic operation and single image-per-eye approach enable quick and accurate screenings.

Its high-contrast optical design can detect small, early-phase retinal changes within a 50° field of view.

The camera also boasts autofocus and auto exposure functions, thereby enhancing ease of use.

It can capture digital images that are readily transferable to eye care providers.

With an estimated 50% of the 38.4 million Americans with diabetes not attending their annual eye exams, the introduction of the Optomed Aurora AEYE could significantly reduce the risk of diabetic retinopathy and potential blindness.

On 30 April, Optomed announced that Optomed Aurora with AEYE-DS received 510(k) clearance from the US Food and Drug Administration.