Therapy Areas: Devices
Optomed gets Chinese regulatory approval for Optomed Aurora
13 November 2020 -

Finnish medical technology company Optomed Plc (HEL:OPTOMED) has received medical devices regulatory approval in China for its latest generation handheld camera, Optomed Aurora, the company reported on Friday.

The clearance from the Chinese Food and Drug Administration (CFDA) allows Optomed to start commercial operations of Optomed Aurora in China. Until now, Optomed has only been able to sell its previous generation camera, Smartscope Pro, in the country.

Optomed Aurora is designed for examination and documentation of the retina for various eye diseases and neurological disorders. The Aurora camera is non-mydriatic, which means there is no need for pupil dilatation when imaging the fundus. It has a 50-degree field-of-view which is useful especially in diabetic retinopathy screening, Optomed said.