Optomed - Health technology company

[j.salli]

@Juha_Kinnunen

At first glance, that appears to be University Hospital Tuebingen’s own study, which is unlikely to be related to either company’s FDA applications. No other sponsors or partners are visible (Not Revenio, Optomed, or a CRO). So, it may be that they are simply using Revenio’s and Optomed’s devices.

It is indeed the University of Tübingen’s own research. The university has developed its own AI model, which was released in May 2025. The model is generalized. Public image data was used for its development. In total, more than 30,000 images were used. This means the images were taken with “just about any” camera.

In the study starting in 2026, they will test the functionality of the AI model in practice with real patients. The primary focus of the study is therefore this new AI model. As a secondary objective, they are investigating the differences between the cameras.

Since this AI model is generalized, it would be convenient to implement it with Lumo in due course.

Edit.

Regarding the FDA clearance matter, in my view, the studies required for FDA clearance are all conducted in the USA. This is due to the diverse population of the USA. It might also be an FDA requirement. The studies related to the Aurora Aeye FDA clearance were conducted in the USA.