DOSIsoft,  a provider of patient-specific medical imaging and dosimetry software solutions for radiation oncology and nuclear medicine,  proudly announces the latest release of PLANET® Onco Dose version 3.2:  a customized, voxel-based, multi-radionuclide dosimetry platform for SIRT and MRT,  now market-approved in the EU under the MDR CE mark and in the US with FDA 510(k) clearance.

Comprehensive, versatile and compatible with any manufacturer, the new version of PLANET® has been specially designed to integrate multiple radionuclides, implement varied workflows, and support multiple therapeutic modalities.

This advanced software release enables clinical centers to address a broader range of therapies by supporting voxel-based dose calculation for the isotopes ⁹⁰Y, ¹⁷⁷Lu, ¹⁶⁶Ho, and  ¹³¹I, with the flexibility to incorporate new beta/gamma emitters.

Clinicians can benefit from optimized workflows for multi-time-point dosimetry and the new single-point dosimetry, enabling reduced workload, improved patient comfort, and streamlined clinical processes without compromising accuracy. Validated through extensive Monte Carlo simulations, this solution delivers GPU-accelerated performance ready for clinical use.

PLANET®, a comprehensive dosimetric solution for patient-specific theranostics, enables highly personalized treatments including 177Lu-PSMA, 177Lu-PRRT, 90Y or 166 Ho radioembolization, ¹³¹I therapies, and more. 

PLANET® Onco Dose has been CE marked according to the new EU Regulation MDR 2017/745 since 17 February 2025.  

PLANET® Onco Dose has received 510(k) clearance from the U.S. FDA since March 14, 2025, extending the previous marketing authorization to version 3.2, which offers a comprehensive feature set. Per the FDA's general rule for radiopharmaceutical therapy (RPT), voxel-based dosimetry solutions are specifically designed for absorbed dose calculation and should only be used with approved radioactive products. 

“It is a historic achievement and a collective effort to provide all the answers to the EU Notified Body and the US FDA. Thanks to our reinforced internal quality system and commitment to the highest standards of safety, performance, and compliance, DOSIsoft positions PLANET ®  Onco Dose for completion, ” said Marc Uszynski, CEO of DOSIsoft. “ We look forward to seeing patients around the world benefit from this safe and effective device in routine clinical use .”