- March 25, 2025
- Category: Press release
Cachan, France | March 25, 2025
DOSIsoft, SA, a leading provider of patient-specific imaging and dosimetry software solutions for radiation oncology and nuclear medicine, is proud to announce its latest product release, PLANET® Onco Dose version 3.2 received FDA 510(k) Clearance on March 14, 2025 from the US Food and Drug Administration, following its EU MDR CE Mark certification.
The novel PLANET® platform is designed to incorporate a multi-radionuclide approach, implement multi-workflow solutions, and support multi-therapy applications for both SIRT (Selective Internal Radiation Therapy) and MRT (Molecular Radiation Therapy) while ensuring compliance with U.S. standards.
Extended to ¹⁷⁷Lu -¹³¹I Targeted Radionuclide-based Therapies (TRT)
Although a previous version of PLANET® Onco Dose was FDA 510(k)-cleared for use with 90Y resin and glass microspheres, this new clearance for the latest software version expands clinical capabilities to include dose computation for ¹³¹Iodine and ¹⁷⁷Lutetium. It also offers the flexibility to integrate additional beta- and gamma-emitting isotopes, adapting to evolving clinical needs.
Introducing new Multiple & Single-Time Point Workflows for Systemic Therapy
Already clinically marketed in the US for oncology features and 90Y-SIRT post-treatment dosimetry, the new version of PLANET® Onco Dose enhances MRT dosimetry (177Lu and 131I) workflows. It implements full 3D and 2D/3D hybrid methods for multi-time point workflows, as well as the newly introduced single-time point workflow to reduce workload, enhance patient comfort, and streamline clinical processes. In this context, the user can benefit from two approaches to perform dosimetry from a single-time point image acquisition: leveraging pharmacokinetics from the prior cycle or applying the population-based/Hänscheid approach.”
Expanded to Support a Broad Range of Treatments
The software can support multiple therapies including 177Lu-PSMA (prostate-specific membrane antigen) therapy, 177Lu-PRRT (peptide receptor radionuclide therapy), 90Y radioembolization, ¹³¹I therapies, enabling highly personalized treatment for each patient.
Additionally, PLANET® Onco Dose version 3.2 operates on a new, long-term supported operating system with enhanced cybersecurity, ensuring compatibility with the latest workstation generations. Validated against thorough Monte-Carlo simulations, this new release also benefits from GPU acceleration to deliver significantly improved performance.
“PLANET® Onco Dose is now available for clinical implementation in the U.S., supporting multiple therapies, radionuclides, and workflows. This achievement is the result of a collective effort by DOSIsoft to meet all U.S. FDA requirements” highlights Jean-Elie Kafrouni, CEO at DOSIsoft Inc., “This new version positions PLANET® Onco Dose ahead of the competition, offering clinicians a comprehensive and adaptable solution for precision dosimetry. We look forward to seeing US patients benefit from this safe and effective device designed for Radiopharmaceutical Therapy (RPT).”
To learn more about PLANET® Onco Dose, the patient-specific Theranostics solution, visit DOSIsoft at the SNMMI Annual Meeting (Booth #1503, June 21–25, 2025)
About PLANET®
PLANET® Onco Dose Edition 3 is developed by DOSIsoft SA in France. It is a Class IIb CE-marked medical device under MDR (EU) 2017/745 and is US FDA 510(k) cleared. Availability of the product or specific features may vary by country and regulatory approval status.
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 & treatment quality. We provide 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 the major cancer institutes and research centers in the world. www.dosisoft.com
Press contact Xiaolu CHEN | xiaolu.chen@dosisoft.com
DOSIsoft SA +33 (0)1 41 24 26 26 | 45/47, Avenue Carnot, 94230 Cachan – France
DOSIsoft Inc. +1 (844) 772-3674 | 2525 Ponce de Leon Ste 300, Coral Gables, FL 33134 – USA