Cerus Corporation has obtained CE mark approval for its INT200, a light-emitting diode (LED)-based illumination device, for the Intercept Blood System for platelets and plasma.
This approval, under the European Union Medical Device Regulation (MDR), enables the company to commercialise the device across the European Union (EU) along with the other regions recognising the CE mark.
An additional “in-country” regulatory approval may be needed for the company in some nations before the product can be marketed.
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Cerus noted that the approval represents the first regulatory approval for its “next-generation” illuminator. And it is planning to pursue further regulatory submissions in the coming years.
The Intercept platelet and plasma systems’ future innovations will leverage the INT200, added the company.
Following the receipt of CE mark approvals for the Intercept processing sets for platelets and plasma under the MDR in 2023, the approval announced now completes the authorisation of the Intercept Blood System for both platelets and plasma within the EU MDR framework.
According to the company, the device features touchscreen navigation, intelligent scanning, and custom reporting. Its contemporary vertical design is claimed to improve workflow and ergonomics, saving space.
Cerus chief operating officer Vivek Jayaraman said: “Taking into account feedback received from our customers, we designed the INT200 to provide a significantly improved user experience and operational benefits through enhanced physical design and a novel software interface while maintaining compatibility with the same disposable processing sets and pathogen inactivation process currently in use.”
Based in California, US, Cerus supplies essential technologies and blood components that are pathogen-protected to hospitals, blood centres, and patients who depend on safe blood.
