Cerus wins regulatory approvals for next-gen blood safety device in France, Switzerland

Next-gen blood safety device wins regulatory approvals in Europe: ©Dazzi-b - stock.adobe.com

Cerus Corp. announced that its next-generation blood safety device, the INT200, has received regulatory approvals from both the French National Agency for Medicines and Health Product Safety and the Swiss Agency for Therapeutic Products.

The INT200 is a vertical, LED-based illumination device designed to enhance the functionality of the INTERCEPT Blood System. It incorporates customer feedback to improve workflow, ergonomics, and usability for blood centers. Among the new features are touch-screen navigation, upgraded tray design, intelligent scanning, and custom reporting.

These national approvals follow CE Mark authorization in March and pave the way for the INT200’s rollout in two countries that have long adopted INTERCEPT technology for platelet safety—France since 2018 and Switzerland since 2011.

“We are pleased with the important in-country approvals in France and Switzerland and view these approvals as an important validation of our technology,” said Vivek Jayaraman, Cerus’ chief operating officer. “France and Switzerland continue to be at the forefront of blood transfusion safety and we value their partnership toward ensuring the safety of the blood supply in their respective countries.”

Cerus plans to replace its installed base of INT100 illuminators across Europe, the Middle East and Africa with the new INT200 units over the next three years. The company also anticipates a premarket approval submission to the U.S. Food and Drug Administration in 2026.

Background: Technology drives new era in blood transfusion safety

Advancements in technology are reshaping the landscape of blood transfusion safety, with innovations aimed at reducing infection risks, improving efficiency, and enhancing traceability. In recent years, a growing emphasis has been placed on modernizing the infrastructure of blood centers through automation, pathogen reduction, and real-time data integration.

One of the most transformative areas has been the adoption of pathogen reduction technologies, which help inactivate a wide range of viruses, bacteria, and parasites in donated platelets and plasma. These systems provide an added layer of safety that traditional donor screening methods may not catch—especially in the face of emerging or re-emerging infectious diseases like Zika virus, dengue, and COVID-19.

At the same time, hardware upgrades—including the shift from older horizontal devices to newer vertical configurations—are making it easier for blood centers to optimize space and improve workflow. Touch-screen interfaces, automated scanning, and integrated reporting tools are also streamlining operations, particularly as many blood banks deal with staffing shortages and rising demand.

Digital transformation is playing a growing role in transfusion medicine as well. Cloud-based platforms and smart devices are enabling better inventory tracking, more accurate matching of blood components, and faster response times during emergencies. Some health systems are even piloting AI-driven tools to forecast supply needs and reduce waste by predicting usage trends.

Regulatory agencies in Europe and North America have supported many of these innovations through updated guidance and approvals, reflecting a global push to make transfusion systems more resilient and responsive. As health care providers look ahead, the integration of smart technology into blood safety protocols is expected to continue accelerating—offering new ways to safeguard one of the most vital components of modern medicine.