Cerus (CERS) announced the CE mark approval of its next-generation LED-based illumination device, or the INT200, for the INTERCEPT Blood System for platelets and plasma under the European Union Medical Device Regulation. This approval allows Cerus to market the INT200 throughout the EU and in other regions that recognize the CE mark. Some countries may require additional in-country regulatory approval prior to commercialization. With the receipt of CE mark approvals of the INTERCEPT processing sets for platelets and plasma under the MDR in 2023, today’s announced approval completes the authorization of the INTERCEPT Blood System for both platelets and plasma within the EU MDR framework.The CE mark is the first regulatory approval received for Cerus’ next-generation illuminator. The Company continues to plan for additional regulatory submissions over the next several years, and future innovation of the INTERCEPT platelet and plasma systems will utilize the INT200
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