Radiopharmaceutical Imaging and Dosimetry (Rapid®) receives FDA clearance for its first 3D-RD™ product: 3D-RD-S
Baltimore, Maryland – Rapid is pleased to announce that it has received FDA 510(k) market clearance for its first software product: 3D-RD-S, the first web-browser based application that implements the MIRD Schema to perform radiopharmaceutical dosimetry calculations. It is based on the most recent ICRP phantoms and data, supports 1,252 radionuclides, and incorporates features that enable alpha-emitter dosimetry, including straight-forward accounting for the fate of daughter radionuclides, and supports use of surrogate radionuclide PK data.
“3D-RD-S implements the MIRD Committee’s S-value based dosimetry; it is the dosimetry software we have all been waiting for. It is available via a web browser and will properly handle dosimetry of alpha-emitting radionuclides and their daughters. It uses the latest and most rigorously vetted ICRP phantoms and data and has a great interface for multi-user calculation and review of dosimetry. Availability of this software takes us one step closer to making dosimetry simple so that cancer patients can benefit by a personalized and precise implementation of radiopharmaceutical therapy.” said Dr. George Sgouros, Chief of Radiologic Physics Division of the Department of Radiology at Johns Hopkins University and Rapid co-founder.
Key functions of 3D-RD-S:
3D-RD-S incorporates S-values based on the latest generation of internationally adopted ICRP phantoms, specific absorbed fractions for adult and pediatric phantoms, and decay data. This software is designed to be especially suited to alpha-particle emitter dosimetry, including flexible accounting for daughter radionuclides and their distribution and incorporation of relative biological effectiveness (RBE) weights. 3D-RD-S is equipped with flexible curve fitting and integration. It provides an investigational mode* that allows calculation of biologically effective dose (BED) & equivalent dose to x-Gray fraction (EQDx) values.
The web application is a platform for dosimetry calculations that enables collaboration that is well-suited for a range of use cases from multi-center, multi-organization clinical trials to a single investigator. The modern web-based interface provides secure access to dosimetry calculations from any location. Full logging of changes is provided. Security features include encryption of data in transit and at rest and 2-factor authentication. Subscription plans and pricing options are available to meet customer needs and budgets. For a demo and pricing options, please email email@example.com
Rapid’s mission to help make cancer curable by providing simplified, accurate and standardized dosimetry that enables routine precision dosing of RPT. Rapid brings more than 90 years of experience in the fields of quantitative imaging and dosimetry to market. Rapid is advancing the standards of dosimetry in radiopharmaceutical therapy (RPT). Rapid provides comprehensive expert services and software solutions related to quantitative imaging, dosimetry, in support of pre-clinical and clinical studies needed for regulatory approval and for the effective and safe clinical implementation of radiopharmaceuticals.
3D-RD-S was designed and developed with support from a loan from the Maryland Technology Development Corporation and by the National Cancer Institute of the National Institutes of Health under award numbers and R43CA224643, R43-CA213782, and R44-CA213782. The product is solely the responsibility of Rapid and does not represent official views of the National Institutes of Health.
*For Investigational Use Only – not part of the 510(k) clearance.
Michael Ghaly, Ph.D.
CTO and Co-Founder