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.
Renalytix expands US clinical footprint with three kidneyintelX.dkd integrations
GSK wins European Commission approval for Shingrix prefilled syringe
Abbott launches Libre Assist for in-the-moment food decisions
RedHill advances RHB-102 across GI indications
FDA grants priority review for Sanofi's Tzield in young children with stage 2 type 1 diabetes
Samsung Bioepis begins direct commercialisation of BYOOVIZ in Europe
Diamyd Medical agrees accelerated efficacy readout in ongoing Phase 3 type 1 diabetes trial
Clywedog Therapeutics activates all clinical centres and patient dosing in balomenib Phase 1b study
Qlife's Egoo Health platform selected for major AI-driven diabetes and MASLD project in China
ALR Technologies announces GluCurve Pet CGM relaunch in Canada
Gan & Lee Pharmaceuticals launches third phase 3 trial of once-monthly bofanglutide
Novo Nordisk reports strong phase 2 results for amycretin in type 2 diabetes
Innovent Biologics reports primary and all key secondary endpoints met in mazdutide Phase 3 trial
Galmed Pharmaceuticals reports topline results for combination of Aramchol, Stivarga and metformin
Adocia files patent for long-acting peptide platform AdoXLong and updates on BioChaperone studies