Rapid® Receives FDA 510(k) Clearance for Integrated, End-to-End Radiopharmaceutical Therapy Dosimetry Platform

New 3D-RD-S imaging functionality brings image review, segmentation, quantification, and MIRD S-value dosimetry together in a single web-based platform

Baltimore, Maryland – September 11, 2026 – Radiopharmaceutical Imaging & Dosimetry, LLC (Rapid) announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for 3D-RD-S, which includes its new optional imaging functionality, 3D-RD-Si. The clearance expands Rapid’s 3D-RD™ platform to provide a more integrated, end-to-end workflow for radiopharmaceutical therapy (RPT) dosimetry.

With the addition of 3D-RD-Si, an optional component that supports image display and analysis, 3D-RD-S now supports the full dosimetry workflow. The new functionality enables users to upload and review DICOM images, generate and edit volumes of interest, extract quantitative imaging statistics, and use those results directly within 3D-RD-S for MIRD S-value dosimetry calculations, all within a single secure, multi-user, multi-role, web-based platform.

The integrated workflow reduces reliance on separate imaging and segmentation software and minimizes manual data transfer between systems. 3D-RD-S provides users with a centralized environment for managing the RPT dosimetry process by consolidating image review, segmentation, quantification, dosimetry calculation, reporting, and data management.

3D-RD-Si also includes initial segmentation to accelerate segmentation while maintaining user oversight. Users must review, modify as needed, and confirm contours before using them for quantitative analysis and dosimetry. Once volumes of interest are finalized, users can extract quantitative values and incorporate them directly into the existing 3D-RD-S workflow.

“With this clearance, we are integrating the steps of the dosimetry workflow that have traditionally required multiple tools and manual data transfer. This increases efficiency and reduces the chance of errors,” said Eric Frey, Ph.D., CEO and Co-Founder of Rapid®. “Our goal with 3D-RD-S has always been to make high-quality radiopharmaceutical dosimetry simple. Integrating imaging display, segmentation, quantification, and dose calculation into one platform represents an important step toward that goal.”

3D-RD-S: One Web-based Platform for the RPT Dosimetry Workflow
3D-RD-S is a secure, browser-based platform designed to support radiopharmaceutical dosimetry without requiring local software installation. With the newly cleared optional imaging functionality (3D-RD-Si), the platform brings together:

  • DICOM image upload and review
  • Interactive image segmentation and contour editing
  • Contour generation to assist user-defined segmentation
  • Quantitative imaging analysis
  • Integration of image-derived data into MIRD S-value dosimetry calculations
  • Dosimetry reporting and centralized data management
  • Multi-user, browser-based access

Together, these capabilities provide a streamlined path from medical images to dosimetry results while maintaining user review and control throughout the process.

Rapid plans to make the newly cleared imaging functionality available in a future software release.

To explore Rapid’s full suite of software and quantitative imaging and dosimetry services, visit: www.rapiddosimetry.com

About Rapid
Rapid provides a growing suite of software solutions alongside comprehensive expert services in quantitative imaging and dosimetry. The company supports both pre-clinical and clinical studies required for regulatory approval and for the safe, effective clinical implementation of radiopharmaceutical therapies. Rapid’s team brings decades of experience in nuclear medicine, quantitative imaging, and dosimetry science.

Media Contact:
Denis Sgouros
Radiopharmaceutical Imaging & Dosimetry, LLC (Rapid®)
dsgouros@rapiddosimetry.com