DOSIsoft's PLANET® Onco Dose Achieves CE MDR and FDA 510(k) Approvals

DOSIsoft Announces Major Milestones for PLANET® Onco Dose

DOSIsoft, a leader in patient-specific imaging and dosimetry software solutions for radiation oncology and nuclear medicine, has recently made significant strides in enhancing cancer treatment options. The company proudly announces that its latest version of PLANET® Onco Dose, Version 3.2, has been awarded the CE MDR marking in the European Union and the FDA 510(k) clearance in the United States. This dual approval is a testament to the product's compliance with stringent safety and performance standards, allowing for its widespread adoption in clinical settings.

Enhanced Features and Capabilities

The updated PLANET® Onco Dose platform stands out as a multiradionuclide, personalized, voxel-based dosimetry platform designed for Selective Internal Radiation Therapy (SIRT) and Molecular Radiotherapy (MRT). It's a versatile and manufacturer-neutral solution, specifically developed to integrate multiple radionuclides, implement various workflows, and accommodate diverse therapeutic approaches.

With the new version, healthcare institutions can address a wider range of therapeutic options. The software supports voxel-based dose calculations for isotopes such as 90Y, 177Lu, 166Ho, and 131I, while also maintaining the flexibility to incorporate new beta and gamma emitters in future iterations.

Clinicians can benefit from optimized dosimetry workflows that permit multiple time points, as well as newly introduced single-point dosimetry workflows. These advancements help reduce workloads, enhance patient comfort, streamline clinical processes, and assure accuracy in treatment. Additionally, the software has been validated through thorough Monte Carlo simulations, ensuring clinically viable performance with GPU acceleration.

A Comprehensive Solution for Personalized Theranostics

DOSIsoft sees PLANET® as an all-in-one dosimetry solution for personalized theranostics, enabling highly tailored treatments, including 177Lu-PSMA, 177Lu-PRRT, 90Y or 166Ho radioembolization, and 131I therapies among others.

Since its CE marking under the new EU-MDR regulation on February 17, 2025, and FDA 510(k) clearance approval on March 14, 2025, this software has significantly expanded its market capabilities. These approvals underscore that voxel-based dosimetry solutions must only be used with approved radiopharmaceutical products, complying with general FDA regulations on radiopharmaceutical therapy.

Commitment to Quality and Safety

Marc Uszynski, CEO of DOSIsoft, emphasizes the collective effort required to meet the expectations of both the EU notified body and the US FDA. He stated, “It is a milestone and a community effort to provide all the answers to regulatory inquiries. Our strengthened internal quality system underpins our commitment to the highest standards regarding safety, performance, and compliance, positioning DOSIsoft's PLANET® Onco Dose for successful utilization in clinical routine.”

DOSIsoft was founded in 2002 and has since become a frontrunner in dosimetry software for radiation oncology and nuclear medicine, working tirelessly to improve patient safety and treatment quality. The company offers competitive patient-specific quality assurance and medical imaging solutions to over 600 hospital centers across 60 countries. As a spin-off of the Gustave Roussy and Curie Institutes in France, DOSIsoft collaborates continuously with leading cancer institutes and research centers globally, such as its recent involvement in the European project Thera4Care.

For more information, visit www.dosisoft.com.