Regulatory News: Novadaq gains CE Mark for OPTTX

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Novadaq Technologies has received CE Mark Certificates to market its OPTTX System in Europe. The OPTTX System is a medical device that allows for diagnosis, treatment and on-going management of wet age-related macular degeneration (AMD) patients, all in a single device. The OPTTX System produces ultra high-speed indocyanine green (ICG) angiograms and facilitates the identification of choroidal feeder vessels (FVs). In addition, the OPTTX System allows for viewing a real-time angiogram in which the treatment laser is able to track and fire precisely while the FV is visible. The system then enables the retinal specialist to immediately confirm the effectiveness of the treatment. This treatment modality with the OPTTX System is called Choroidal Vessel Closure (CVC), which has evolved from the conventional feeder vessel therapy (FVT), that uses two medical devices, one for imaging, and the second for treatment, the company said.