QDOSE® USFDA Announcement

QDOSE® Multi-purpose Voxel Dosimetry Software (Personalized Dosimetry in Molecular Radiotherapy) received USFDA 510(k) clearance in August 2023. Developed by ABX-CRO (Dresden, Germany) in collaboration with Quantinm AB (Stockholm, Sweden), this software provides state-of-the-art assessment of radiation absorbed dose to organs and tissues of the body from medically administered radiopharmaceuticals. It is a complete, one-stop solution for all internal dosimetry needs with multiple parallel workflows. QDOSE® features fully automated organ segmentation, single time-point dosimetry, and one-click hybrid dosimetry capabilities, supported by algorithms for fast data processing and an extensive radionuclide database. Integrated with IDAC-DOSE2.1, QDOSE® provides reliable estimates of organ absorbed dose and effective dose for clinical applications in nuclear medicine and molecular radiotherapy.

Versant Medical Physics, the US distributor for QDOSE® Multi-purpose Voxel Dosimetry Software, reflects the software’s reliability and efficacy in radiation dose assessment. Their distribution emphasizes the software’s suitability for medical physicists, radiologists, and nuclear medicine physicians given its user-friendly and versatile design.

Dr. Darrell Fisher, a nuclear medicine physicist at Versant Medical Physics, highlights the software’s proven performance and versatility. “QDOSE®,” he explains, “is a comprehensive and standalone dosimetry software suite. It efficiently calculates radiation absorbed doses to the human body following the administration of radiopharmaceutical products. It simplifies dosimetry by integrating steps from image data import to processing, analysis, and reporting. The software supports a variety of workflows, including planar (2D), hybrid (2.5D), and volumetric (3D) dosimetry, and a specialized module for yttrium-90 selective internal radiation therapy (SIRT). QDOSE®, in conjunction with IDAC-Dose2.1, adheres to the MIRD schema, stylized models, and processes as established by the International Commission on Radiological Protection (ICRP). With both FDA clearance and the European CE Mark, QDOSE® stands out as a comprehensive tool for diagnostic and therapeutic radiopharmaceutical dosimetry.”

QDOSE® serves as a demonstration of Quantinm AB’s commitment to delivering safe and effective solutions to the theragnostic community and Versant Medical Physics is proud to be the sole vendor of QDOSE® for North America. 

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