Optomed and Aireen announce strate­gic part­ner­ship and achieve approval for AI-pow­ered hand­held dia­bet­ic retinopa­thy screen­ing

Optomed and Aireen a.s., a pio­neer in AI-dri­ven med­ical diag­nos­tics, have announced a strate­gic part­ner­ship to deliv­er AI-pow­ered hand­held imag­ing solu­tions. As part of this col­lab­o­ra­tion, Optomed’s flag­ship hand­held fun­dus cam­era, Optomed Lumo®, has been approved for inte­gra­tion with Aireen’s AI algo­rithm for dia­bet­ic retinopa­thy screen­ing in the EU mar­ket. 

This reg­u­la­to­ry mile­stone enables the com­mer­cial launch of Optomed Lumo with Aireen AI inte­gra­tion across Euro­pean mar­kets. Aireen’s algo­rithm is cer­ti­fied as an MDR Class IIb CE-marked med­ical device, ensur­ing com­pli­ance with the high­est Euro­pean safe­ty and per­for­mance stan­dards. The com­bined solu­tion brings AI-pow­ered dia­bet­ic retinopa­thy screen­ing direct­ly into pri­ma­ry care, oph­thal­mol­o­gy prac­tices, mobile screen­ing pro­grams, and health­care systems—expanding access to ear­ly detec­tion and reduc­ing the bur­den on spe­cial­ist care.

Beyond dia­bet­ic retinopa­thy, the part­ner­ship lays the ground­work for future AI diag­nos­tic appli­ca­tions on the Optomed Lumo plat­form, poten­tial­ly address­ing a wider range of reti­nal and sys­temic dis­eases to fur­ther enhance the val­ue of hand­held imag­ing tech­nol­o­gy.

“This part­ner­ship rep­re­sents our com­mit­ment to trans­form­ing hand­held imag­ing into a scal­able AI-pow­ered diag­nos­tic plat­form,” said Juho Him­berg, CEO of Optomed Plc. “The Optomed Lumo was engi­neered as an ide­al AI inte­gra­tion plat­form, and achiev­ing reg­u­la­to­ry approval with Aireen AI inte­grat­ed val­i­dates this strat­e­gy while open­ing the door to future AI-enabled solu­tions.”

A recent study pub­lished in Dia­betes Tech­nol Ther. (2025) con­firmed the clin­i­cal per­for­mance of Aireen’s dia­bet­ic retinopa­thy algo­rithm, which demon­strat­ed 94.8% sen­si­tiv­i­ty, 91.4% speci­fici­ty, and 92.7% over­all accu­ra­cy using Optomed’s hand­held imag­ing.

“We are thrilled to part­ner with Optomed to make AI-pow­ered dia­bet­ic retinopa­thy screen­ing more acces­si­ble than ever,” said Jiří Kuchyňa, CEO of Aireen a.s. “The recent clin­i­cal study con­firms that our AI algo­rithm deliv­ers spe­cial­ist-lev­el per­for­mance when used with a hand­held device like the Optomed Lumo. The lev­el of accu­ra­cy, com­bined with the porta­bil­i­ty and usabil­i­ty of Optomed Lumo, has the poten­tial to trans­form how and where reti­nal screen­ing can be deliv­ered, from pri­ma­ry care to mobile screen­ing pro­grams. We see this as an impor­tant step toward our shared vision of enabling ear­li­er detec­tion, reduc­ing pre­ventable vision loss, and eas­ing the bur­den on spe­cial­ist care.”

With dia­betes preva­lence ris­ing glob­al­ly, the demand for scal­able, cost-effi­cient, and acces­si­ble screen­ing solu­tions is accel­er­at­ing. This part­ner­ship posi­tions Optomed and Aireen at the fore­front of the fast-grow­ing mar­ket for AI-dri­ven diag­nos­tic tools, com­bin­ing cut­ting-edge imag­ing tech­nol­o­gy with advanced AI diag­nos­tics to improve patient out­comes and expand health­care capac­i­ty.

Con­tact per­son

Juho Him­berg

CEO, Optomed Plc

juho.himberg@optomed.com

Source: Optomed