DOSIsoft PLANET Onco Dose receives FDA Clearance and CE MDR Mark

April 7, 2025 — DOSIsoft, a provider of patient-specific imaging and dosimetry software solutions, recently announced the latest release of PLANET Onco Dose version 3.2 – multi-radionuclide, personalized, voxel-based dosimetry platform for SIRT and MRT – has received FDA 510(k) clearance in the U.S. and is now approved for market in EU under CE MDR Mark.

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 Feb. 17, 2025.

PLANET Onco Dose is US FDA 510(k) cleared since March 14, 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.Click here to 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."