DOSIsoft's PLANET® Onco Dose Achieves Major Approvals in Europe and the USA

DOSIsoft's PLANET® Onco Dose Achieves Major Approvals

In a significant milestone, DOSIsoft, an industry leader in patient-specific imaging and dosimetry solutions for radiation oncology and nuclear medicine, has announced the successful approval of its PLANET® Onco Dose software version 3.2. This updated platform has received the CE MDR Mark, allowing it to be marketed throughout the European Union, and has also gained FDA 510(k) clearance in the United States.

The PLANET® Onco Dose is a versatile and innovative dosimetry platform specifically designed for multi-radionuclide, voxel-based dosimetry. It significantly enhances the capabilities of clinics, enabling them to implement diverse workflows and support various therapies. The new version is aimed to cover a broader array of treatments by facilitating voxel-based dose calculations for isotopes such as 90Y, ¹⁷⁷Lu, ¹⁶⁶Ho, and ¹³¹I, while also allowing for the integration of additional beta/gamma emitters in the future.

One of the noteworthy advancements of this platform is its optimized dosimetry workflows for both multiple time points and the newly introduced single-time point dosing options. These enhancements are designed to reduce the clinician's workload, boost patient comfort, and streamline clinical processes while also maintaining accuracy. The software has been validated through rigorous Monte Carlo simulations, offering reliable GPU-accelerated performance that is ready for clinical application.

The PLANET® Onco Dose serves as a comprehensive solution tailored for patient-specific theranostics, providing clinicians the tools necessary for administering highly personalized treatments for conditions requiring radioembolization therapies such as177Lu-PSMA, 177Lu-PRRT, and others.

Achieving the CE Mark under the new EU MDR Regulation 2017/745 on February 17, 2025, marks an important step forward for DOSIsoft, indicating a commitment to the highest safety, performance, and compliance standards. The FDA 510(k) clearance, granted on March 14, 2025, reflects further expansion of market availability and underscores the advanced features of the new version 3.2.

Marc Uszynski, CEO of DOSIsoft, expressed optimism regarding the future impact of their software, highlighting the collective effort that has led to these approvals. "It is a milestone achievement and a collective work to provide all answers to the EU notified body and US FDA," Uszynski noted. "Through our reinforced internal Quality System and commitment to the highest standards, DOSIsoft positions PLANET® Onco Dose ahead of competition. We are excited to see patients worldwide benefit from this safe and effective device in routine clinical use."

Founded in 2002, DOSIsoft has emerged as a leader in the market for dosimetry software in Radiation Oncology and Nuclear Medicine, emphasizing patient safety and treatment quality. Their innovative solutions are already utilized in over 600 hospital centers across 60 countries, reflecting a strong legacy in improving cancer patient care. DOSIsoft continues to innovate through collaborative efforts with leading cancer institutes and research organizations globally, including partnerships established under the Thera4Care European project.

For more information about DOSIsoft and its products, visit their official website at www.dosisoft.com.