DOSIsoft PLANET® Onco Dose receives CE MDR Mark and new FDA 510(k) clearance

PARIS, April 7, 2025 /PRNewswire/ -- DOSIsoft, leading provider of patient-specific imaging and dosimetry software solutions for radiation oncology and nuclear medicine, proudly announces the latest release of PLANET^® Onco Dose version 3.2 – multi-radionuclide, personalized, voxel-based dosimetry platform for SIRT and MRT – now approved for market in EU under CE MDR Mark and in the US with FDA 510(k) clearance.

End-to-end, versatile, vendor-neutral, the novel PLANET^® release is specially designed to integrate multi-radionuclide, implement multi-workflow and support multi-therapy.

This advanced software version allows clinics to cover a broader range of therapies by supporting voxel-based dose computation for ⁹⁰Y, ¹⁷⁷Lu ¹⁶⁶Ho and ¹³¹I isotopes with the flexibility to incorporate new beta/gamma emitters.

Clinicians can benefit from optimized multi-time point and newly introduced single-time point dosimetry workflows – reducing workload, enhancing patient comfort, streamlining clinical processes while ensuring accuracy. Validated against thorough Monte-Carlo simulations, it offers clinical-ready GPU-accelerated performances.

"All-in-one dosimetry solution for Patient specific Theranostics," PLANET^® enables highly personalized treatments including ¹⁷⁷Lu-PSMA, ¹⁷⁷Lu-PRRT, ⁹⁰Y or ¹⁶⁶Ho radioembolization, ¹³¹I therapies, and more.

PLANET^® Onco Dose is CE Marked under new EU MDR Regulation 2017/745 since February 17^th, 2025. Learn more.

PLANET^® Onco Dose is US FDA 510(k) cleared since March 14^th, 2025, expanding previous market clearance to version 3.2 rich feature set. As per FDA general rule for Radiopharmaceutical Therapy (RPT), voxel-based dosimetry solutions are intended specifically for absorbed dose calculation and should only be used with approved radioactive products. Learn more.

"It is a milestone achievement and a collective work to provide all answers to the EU notified body and US FDA, Through our reinforced internal Quality System and commitment to the highest standards of safety, performance and compliance, DOSIsoft positions PLANET^® Onco Dose, ahead of completion," highlights Marc Uszynski, CEO at DOSIsoft. "We are looking forward to seeing patients worldwide benefit from this safe and effective device in routine clinical use."

About DOSIsoft

Founded in 2002, DOSIsoft stands as market leader specialized in dosimetry software in Radiation Oncology and Nuclear Medicine to improve cancer patient safety and treatment quality. DOSIsoft provides the most competitive patient-specific quality assurance and medical imaging solutions in over 600 hospital centers in 60 countries. Spin-off between Gustave Roussy and Curie Institute in France, DOSIsoft constantly innovates in partnership with leading cancer institutes and research centers in the world, like recently through the Thera4Care European project. www.dosisoft.com.

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Contact:
Mme Xiaolu Chen
Service Marketing
xiaolu.chen@dosisoft.com