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

DOSIsoft's PLANET® Onco Dose Secures Major Regulatory Approvals

In a significant advancement for the field of radiation oncology, DOSIsoft has announced that its pioneering software, PLANET® Onco Dose version 3.2, has successfully earned both the CE MDR Mark and FDA 510(k) clearance. This approval represents a strong commitment to enhancing safe and effective cancer treatment through technological innovation.

The PLANET® Onco Dose is a multi-radionuclide, voxel-based dosimetry platform specially designed for Selective Internal Radiation Therapy (SIRT) and Metabolic Radiotherapy (MRT). Offering a comprehensive end-to-end solution that is vendor-neutral, the software allows clinics to integrate various radionuclides, thereby accommodating different therapeutic workflows.

With its latest version, PLANET® Onco Dose offers voxel-based dose computation for several isotopes including 90Y, ¹⁷⁷Lu, ¹⁶⁶Ho, and ¹³¹I. This flexibility ensures clinics can easily adapt to new beta and gamma emitters in the future. Furthermore, clinicians stand to benefit from streamlined dosimetry workflows, which not only reduce workloads but also enhance patient comfort and streamline clinical processes.

DOSIsoft’s software has been validated through rigorous Monte-Carlo simulations, providing assurance of high accuracy in clinical settings. The GPU-accelerated performance capabilities of PLANET® Onco Dose equip healthcare professionals with an effective tool to optimize treatment dosimetry while maintaining patient safety.

Marc Uszynski, the CEO of DOSIsoft, remarked on the significance of this achievement. He noted that the rigorous process of gaining approvals from both the EU and the FDA required substantial work to address essential quality and safety standards. With a robust internal Quality System in place, the firm underscores its dedication to compliance and performance, further emphasizing that their tool is designed to advance patient outcomes in cancer treatment across the globe.

The CE Mark is pivotal as it indicates compliance with EU safety and performance regulations, facilitating the marketing of PLANET® Onco Dose throughout Europe. As of February 17th, 2025, this product adheres to the new EU MDR Regulation 2017/745. Meanwhile, the FDA clearance, received on March 14th, 2025, expands the existing market authorization to include the rich feature set of version 3.2. Importantly, both regulations specify that voxel-based dosimetry solutions must be paired with approved radioactive products, ensuring maximum safety during treatments.

Upon reflecting on the future, Uszynski expressed optimism that patients worldwide will significantly benefit from the advanced features of PLANET® Onco Dose, facilitating personalized therapies like 177Lu-PSMA, 177Lu-PRRT, 90Y, and ¹³¹I treatments.

Founded in 2002, DOSIsoft has positioned itself as a leader in dosimetry software within radiation oncology and nuclear medicine, impacting the safety and quality of cancer treatment for patients. The company operates in over 600 hospital centers across 60 countries, continually innovating through collaboration with top cancer research institutions. Their recent involvement in the European project Thera4Care exemplifies their ongoing dedication to cutting-edge research and the development of effective cancer therapies.

For more information about DOSIsoft and its offerings, including the features and applications of PLANET® Onco Dose, visit www.dosisoft.com.