- Cerus Corporation secures regulatory approval for its INT200 device in France and Switzerland.
- The INT200 is intended to enhance the INTERCEPT Blood System with improved workflow and ergonomics.
- Commercial rollout has begun, with plans for further global regulatory submissions.
Cerus Corporation (CERS, Financial) has announced that its next-generation INT200 illumination device has achieved in-country regulatory approvals in France and Switzerland. The French National Agency for Medicines and Health Product Safety (ANSM) and the Swiss Agency for Therapeutic Products (Swissmedic) have both given the green light for the INT200, which is designed to augment the INTERCEPT Blood System for platelets and plasma use.
The INT200 incorporates user-friendly features such as a vertical configuration that maximizes bench space, with three devices fitting into the footprint of a single INT100. The device also boasts touch screen navigation and improved software, tray design, intelligent scanning, and custom reporting functionalities. These features aim to better facilitate daily operations in blood centers and are poised to replace the existing INT100s in the EMEA region over the next three years.
This development follows a CE Mark authorization received in March, marking significant progress in Cerus' efforts to expand the INT200's market. Vivek Jayaraman, Chief Operating Officer of Cerus, expressed optimism about these approvals, highlighting the importance of partnerships with France and Switzerland in advancing blood transfusion safety.
Looking ahead, Cerus intends to submit additional regulatory filings, including a Premarket Approval (PMA) submission to the FDA, expected in 2026. The company is also planning further innovations for the INTERCEPT Blood System to leverage the INT200 platform, reinforcing its commitment to safeguarding the global blood supply.
