DOSIsoft Announces Major Advancements in Onco Dose Technology
DOSIsoft, a leader in developing patient-specific imaging and dosimetry software solutions for radiation oncology and nuclear medicine, has recently achieved noteworthy milestones. The company proudly presents the latest version of its innovative software, PLANET® Onco Dose, which has successfully received the CE MDR Mark for markets within the European Union and attained the FDA 510(k) clearance for use in the United States.
Key Features of PLANET® Onco Dose Version 3.2
Designed for multi-radionuclide therapies, PLANET® Onco Dose version 3.2 is a versatile platform that simplifies the process of personalized voxel-based dosimetry, which is crucial for selective internal radiation therapy (SIRT) and molecular radiotherapy (MRT). This comprehensive software solution allows healthcare providers to adapt to various treatment protocols effectively.
Enhanced Therapeutic Capabilities
Clinics utilizing this advanced software can optimize their treatment offerings by supporting dosage calculations for isotopes such as 90Y, 177Lu, 166Ho, and 131I. The framework provides flexibility to include new beta and gamma emitters, enhancing its usability for various clinical applications.
Optimized Workflows for Improved Patient Care
The new version introduces optimized multi-time point options alongside newly implemented single-time point dosimetry workflows, which serve to alleviate the burdens on clinicians. These modifications not only enhance the patient's experience but also promote efficiency within clinical settings, ensuring that accuracy remains a priority. The software's capabilities have been validated against rigorous Monte Carlo simulations, confirming its readiness for clinical use.
Future-Proofing Dosimetry in Oncology
One of the standout features of the PLANET® Onco Dose platform is its all-in-one dosimetry solution tailored for patient-specific theranostics. This innovative technology offers adaptability in treatments, allowing for personalized approaches for therapies including 177Lu-PSMA, 177Lu-PRRT, 90Y radioembolization, and more. As more therapies get developed, the software remains equipped to integrate these advancements seamlessly.
Achievements in Regulatory Compliance
The successful approval of PLANET® Onco Dose under the new EU MDR Regulation showcases DOSIsoft's commitment to delivering high-quality, compliant technological solutions. Achieving CE marking as of February indicates that the software meets essential safety and efficacy standards in Europe, a significant milestone for the company.
FDA 510(k) Clearance Expands Market Options
Additionally, the FDA's 510(k) clearance issued in March represents a significant expansion of the software's features and capabilities. With this approval, the platform is further positioned to support its intended role in the practical application of radiopharmaceutical therapy, focusing on accurate absorbed dose calculations for already approved radioactive products.
Commitment to Quality and Patient Safety
Marc Uszynski, CEO of DOSIsoft, emphasizes the importance of this achievement, noting that the validation process involved comprehensive collaboration with regulatory bodies. This innovative approach aimed at reinforcing the internal Quality Management System ensures compliance with the highest standards, ultimately enhancing the treatment experience for oncology patients worldwide. The company is eager to see its device widely adopted within routine clinical practice.
About DOSIsoft
Founded in 2002, DOSIsoft is recognized as a market leader in developing dosimetry solutions tailored for Radiation Oncology and Nuclear Medicine, enhancing the quality of cancer patient care. With a reach encompassing over 600 hospital centers across 60 countries, DOSIsoft remains at the forefront of innovation in partnership with various esteemed cancer research institutes globally.
Frequently Asked Questions
What is the significance of the CE MDR Mark for DOSIsoft?
The CE MDR Mark indicates compliance with European safety and performance standards for medical devices, enhancing the credibility of the PLANET® Onco Dose platform.
How does the FDA 510(k) clearance benefit the use of Onco Dose?
The FDA 510(k) clearance allows for the use of PLANET® Onco Dose in the U.S. healthcare market, expanding its availability and operational features for practitioners.
What are voxel-based dosimetry calculations?
Voxel-based dosimetry calculations involve breaking down a volume into smaller units to deliver precise dosage metrics for individual patients based on their specific treatment needs.
What types of therapies can PLANET® Onco Dose support?
This platform supports various therapies, including but not limited to 177Lu-PSMA, 177Lu-PRRT, and 90Y radioembolization, providing flexible treatment options.
How can patients and clinics benefit from PLANET® Onco Dose technology?
Clinics benefit from increased efficiency and accuracy in treatment protocols, while patients can expect personalized care that prioritizes their safety and therapeutic outcomes.
