Radformation’s Automation Solutions Achieve MDR CE Mark

Radformation’s Automation Solutions Achieve MDR CE Mark

Melanie Benton
Director of Marketing
mbenton@radformation.com

Radformation Inc., a global pioneer in radiation oncology software solutions, is proud to announce that AutoContour, ClearCheck, ClearCalc, and ChartCheck have achieved the EU Medical Device Regulation (MDR) CE Mark certification. This certification verifies that Radformation complies with the European Union’s (EU) Regulation 2017/745 and other recognized standards, ensuring adherence to stringent health, safety, and environmental protection standards.

As the global cancer burden continues to rise, Radformation solutions play a crucial role in accelerating every stage of the radiation oncology workflow. By automating critical, yet-time intensive tasks, Radformation empowers clinicians to prioritize quality care, ensuring patients receive faster access to treatment.

With MDR CE Mark certification, clinics across Europe and other countries where the CE Mark is accepted, can now leverage these tools:

AutoContour: Improves treatment planning by significantly reducing the time required for manual contouring, providing AI-driven, clinically-validated contours within minutes.
ClearCheck: Automates plan quality checks to ensure compliance with clinical standards, improving plan quality and documentation accuracy.
ClearCalc: Provides independent dose calculation verification, patient-specific quality assurance, and gold-standard radiotherapy calculation with RadMonteCarlo, to instill confidence in treatment accuracy while boosting efficiency and streamlining QA processes
ChartCheck: Actively monitors patient data in real-time for automated safety and compliance checks during treatment delivery.

“Achieving MDR CE Mark is a significant milestone in Radformation’s mission to advance global cancer care,” said Kurt Sysock, CEO at Radformation. “We are excited to bring our solutions to CE mark regions, empowering clinics to enhance efficiency and safety in their workflows.”

About Radformation

Radformation is committed to improving the lives of clinicians by delivering user-friendly products developed to increase the safety and quality of cancer treatment. Radformation envisions a radiation oncology clinic where staff are equipped with solutions that supplement their expertise and automate time-consuming tasks, leading to better patient care everywhere. Since its founding in 2016, Radformation has grown to serve over 2,000 clinics around the world in 28 countries with a portfolio of products accelerating all stages of the treatment planning workflow. For more information, visit radformation.com.