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

On April 17, 2025, DOSIsoft, a leading provider of patient-specific software solutions in medical imaging and dosimetry for radiation oncology and nuclear medicine, proudly announced the launch of its latest version of PLANET® Onco Dose. This innovative platform has recently been granted both the CE MDR mark for the EU market and 510(k) clearance from the FDA in the United States.

A Breakthrough in Patient-Specific Dosimetry

The new version 3.2 of PLANET® Onco Dose is specifically designed to provide integrated multiradionuclide dosimetry through a voxel-based approach. This technology is intended for use in Selective Internal Radiation Therapy (SIRT) and Molecular Radiotherapy (MRT), making it incredibly versatile and compatible with any manufacturer’s workflow.

One of the standout features of this upgraded software is its ability to integrate multiple radionuclides, which supports a host of therapeutic modalities. This latest version allows clinical centers to treat a wider variety of therapies, as it facilitates voxel-based dose calculations for isotopes such as 90Y, 177Lu, 166Ho, and 131I. Additionally, it remains flexible enough to incorporate new beta/gamma emitters, paving the way for future advancements in radiotherapy

Enhanced Clinical Workflows

DOSIsoft's PLANET® Onco Dose offers optimized workflows for dosimetry at multiple time points along with a new single-point dosimetry feature. This update is designed to alleviate the workload of healthcare providers while enhancing patient comfort and streamlining clinical processes without sacrificing accuracy. The software has been validated utilizing extensive Monte Carlo simulations, ensuring that it meets the highest standards of clinical performance. GPU-accelerated operations further enhance its readiness for routine clinical use.

Customizable Treatments for Patients

This comprehensive dosimetry solution is tailored for theranostics—treatment highly personalized to meet the specific needs of each patient. Treatments made possible include 177Lu-PSMA, 177Lu-PRRT, 90Y radioembolization, and therapies using 166Ho and 131I. The CE mark under the new EU MDR Regulation 2017/745 was received on February 17, 2025, while the FDA approval was granted on March 14, 2025. This expanded marketing authorization introduces a wealth of features aimed at enhancing the precision and effectiveness of radioactive therapies as detailed in FDA regulations pertaining to radiopharmaceutical therapy (RPT).

Commitment to Safety and Performance

Marc Uszynski, CEO of DOSIsoft, expressed the company’s pride in this achievement, stating, “It’s a historic milestone and a collaborative effort to provide all necessary responses to the EU Notified Body and the FDA. Thanks to our enhanced internal quality system and commitment to the highest standards of safety, performance, and compliance, DOSIsoft is successfully on track to complete this project.” Uszynski emphasized hopes for patients worldwide to benefit from the safe and efficient use of this device in routine clinical settings.

About DOSIsoft

Founded in 2002, DOSIsoft has established itself as a market leader specializing in dosimetry software for radiation oncology and nuclear medicine. The goal is to improve the safety and quality of treatment for cancer patients. DOSIsoft offers the most competitive quality assurance and patient-specific imaging solutions across over 600 hospitals in 60 countries. As a spin-off from Gustave Roussy and the Curie Institute in France, the company continually seeks innovation in partnership with leading oncology institutes and research centers globally, including contributions to the recent European project Thera4Care. www.dosisoft.com