DOSIsoft's PLANET® Onco Dose Achieves CE MDR Mark and FDA 510(k) Approval
DOSIsoft, a prominent developer of software solutions for imaging and dosimetry in radiation therapy and nuclear medicine, has made headlines with its latest announcement regarding the PLANET® Onco Dose version 3.2. This comprehensive dosimetry platform is specifically tailored for voxel-scale imaging and allows for multi-radionuclide applications in selective internal radiation therapy (SIRT) and molecular radiotherapy (MRT).
Recently, PLANET® Onco Dose has gained significant recognition by acquiring the CE mark under the EU Medical Device Regulation (MDR) and a 510(k) clearance from the FDA in the United States. These approvals mark a pivotal point in the company's journey, allowing them to broaden their market reach and offer advanced solutions in oncology.
The new version of PLANET® introduces improvements that allow clinics to efficiently accommodate a wider range of therapies. It supports voxelized dose calculations for isotopes such as 90Y, 177Lu, 166Ho, and 131I, showcasing flexibility with the option to incorporate new beta/gamma emitters. This capability is crucial for modern clinical workflows, as it helps to optimize dosimetry processes, thereby enhancing patient comfort and simplifying clinical procedures.
The latest software release has been validated using robust Monte Carlo simulations and provides accelerated performance through GPU acceleration, making it ready for clinical implementation. This all-in-one dosimetry solution is essential for personalized theranostics, ensuring tailored treatment approaches for conditions like Yttrium-90 radioembolization and other therapies involving Lutetium-177.
DOSIsoft's efforts have culminated in achieving the CE mark on February 17, 2025, and the FDA's 510(k) authorization on March 14, 2025. These regulatory approvals validate the company’s commitment to maintaining the highest standards of quality, safety, and compliance in patient care. As emphasized by Marc Uszynski, CEO of DOSIsoft, the achievement reflects a collective effort within the organization and highlights its dedication to innovation and excellence in ensuring patient safety.
New dosimetry workflows introduced in this version facilitate multi-time point dosimetry, alongside a unique single-time point dosimetry workflow that combines efficiency with user-friendly processes. The progressive features aim to significantly reduce the workload of clinicians while guaranteeing optimal precision in dose delivery, all designed to enhance the patient experience in clinical settings.
Founded in 2002 and emerging from a spin-off of prestigious institutions like Gustave Roussy and Curie Institute in France, DOSIsoft has been a leader in dosimetry software for radiation therapy and nuclear medicine. The company aims to improve cancer treatment outcomes and patient safety by providing competitive quality assurance and imaging solutions. The company services over 600 hospital centers across 60 countries, underscoring its wide-reaching impact on global healthcare.
DOSIsoft continues to partner with leading cancer research centers, contributing to projects like the European Thera4Care initiative, which further strengthens its position in the market. The announcement of PLANET® Onco Dose's new features is poised to make a positive impact on patient treatment protocols.
With the CE mark and FDA 510(k) authorization now achieved, DOSIsoft's PLANET® Onco Dose is set to transform the clinical landscape for radiation therapy. As hospitals around the world adopt this innovative platform, the future of patient care in oncology looks more promising than ever. DOSIsoft stands at the forefront of this technological evolution, ensuring safe and effective treatment options are available to patients globally.
Recently, PLANET® Onco Dose has gained significant recognition by acquiring the CE mark under the EU Medical Device Regulation (MDR) and a 510(k) clearance from the FDA in the United States. These approvals mark a pivotal point in the company's journey, allowing them to broaden their market reach and offer advanced solutions in oncology.
Comprehensive Solutions
The new version of PLANET® introduces improvements that allow clinics to efficiently accommodate a wider range of therapies. It supports voxelized dose calculations for isotopes such as 90Y, 177Lu, 166Ho, and 131I, showcasing flexibility with the option to incorporate new beta/gamma emitters. This capability is crucial for modern clinical workflows, as it helps to optimize dosimetry processes, thereby enhancing patient comfort and simplifying clinical procedures.
The latest software release has been validated using robust Monte Carlo simulations and provides accelerated performance through GPU acceleration, making it ready for clinical implementation. This all-in-one dosimetry solution is essential for personalized theranostics, ensuring tailored treatment approaches for conditions like Yttrium-90 radioembolization and other therapies involving Lutetium-177.
Regulatory Approvals
DOSIsoft's efforts have culminated in achieving the CE mark on February 17, 2025, and the FDA's 510(k) authorization on March 14, 2025. These regulatory approvals validate the company’s commitment to maintaining the highest standards of quality, safety, and compliance in patient care. As emphasized by Marc Uszynski, CEO of DOSIsoft, the achievement reflects a collective effort within the organization and highlights its dedication to innovation and excellence in ensuring patient safety.
New dosimetry workflows introduced in this version facilitate multi-time point dosimetry, alongside a unique single-time point dosimetry workflow that combines efficiency with user-friendly processes. The progressive features aim to significantly reduce the workload of clinicians while guaranteeing optimal precision in dose delivery, all designed to enhance the patient experience in clinical settings.
The Company's Legacy
Founded in 2002 and emerging from a spin-off of prestigious institutions like Gustave Roussy and Curie Institute in France, DOSIsoft has been a leader in dosimetry software for radiation therapy and nuclear medicine. The company aims to improve cancer treatment outcomes and patient safety by providing competitive quality assurance and imaging solutions. The company services over 600 hospital centers across 60 countries, underscoring its wide-reaching impact on global healthcare.
DOSIsoft continues to partner with leading cancer research centers, contributing to projects like the European Thera4Care initiative, which further strengthens its position in the market. The announcement of PLANET® Onco Dose's new features is poised to make a positive impact on patient treatment protocols.
Conclusion
With the CE mark and FDA 510(k) authorization now achieved, DOSIsoft's PLANET® Onco Dose is set to transform the clinical landscape for radiation therapy. As hospitals around the world adopt this innovative platform, the future of patient care in oncology looks more promising than ever. DOSIsoft stands at the forefront of this technological evolution, ensuring safe and effective treatment options are available to patients globally.
Topics Health）
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