Optomed Auro­ra with AEYE has received FDA clear­ance in the US

Optomed Plc, a lead­ing med­ical tech­nol­o­gy com­pa­ny, has achieved a sig­nif­i­cant mile­stone with the FDA clear­ance for its inno­v­a­tive prod­uct, the AEYE-DS with Optomed Auro­ra. This hand­held AI screen­ing solu­tion is designed to rev­o­lu­tion­ize reti­nal imag­ing and diag­nos­tics.

Key Fea­tures

• FDA 510(k) Clear­ance:

The Optomed Auro­ra with AEYE has received a 510(k) clear­ance from the U.S. Food & Drug Admin­is­tra­tion (FDA). This reg­u­la­to­ry approval allows Optomed to mar­ket and sell the AI cam­era in the Unit­ed States.

• First-of-Its-Kind AI Screen­ing Solu­tion:

The Auro­ra AEYE stands out as the first hand­held AI screen­ing solu­tion to obtain FDA clear­ance. Its com­pact design and ease of use make it a game-chang­er in the field of oph­thal­mol­o­gy.

• Sin­gle-Image Screen­ing:

With just one image per eye, the Auro­ra AEYE per­forms com­pre­hen­sive screen­ing for con­di­tions such as dia­bet­ic retinopa­thy. This effi­cien­cy stream­lines the diag­nos­tic process and reduces patient wait times.

• Rapid Results:

With­in 60 sec­onds, the Auro­ra AEYE deliv­ers results, allow­ing health­care pro­fes­sion­als to make informed deci­sions prompt­ly. Real-time analy­sis enhances patient care and ensures time­ly inter­ven­tions.

‘We’re thrilled to be receiv­ing the first-ever FDA clear­ance for a portable AI screen­ing solu­tion, and we extend our appre­ci­a­tion to Optomed. Their unwa­ver­ing col­lab­o­ra­tion and shared vision have been instru­men­tal in this remark­able achieve­ment. Togeth­er we have demon­strat­ed the pow­er of part­ner­ship and inno­va­tion in advanc­ing health­care tech­nol­o­gy for the bet­ter­ment of all. This is a true game-chang­er, and we can­not be more excit­ed to see Auro­ra AEYE in the mar­ket’, com­ment­ed Zack Dvey-Aharon, Ph.D., Co-Founder and CEO of AEYE Health.

Optomed in brief

Optomed is a Finnish med­ical tech­nol­o­gy com­pa­ny and a lead­ing man­u­fac­tur­er of hand­held fun­dus cam­eras and screen­ing soft­ware. Optomed com­bines hand­held fun­dus cam­eras with soft­ware and arti­fi­cial intel­li­gence to trans­form the diag­nos­tic process of var­i­ous dis­eases, such as rapid­ly increas­ing dia­bet­ic retinopa­thy. Optomed has offices in Fin­land, the US, and Chi­na and the company’s prod­ucts are sold via mul­ti­ple sales chan­nels in over 60 coun­tries glob­al­ly.

Source: Optomed