Rapid

The Rapid system is an image processing software package designed to provide physicians with advanced visualization and analysis of CT and MRI data, including specialized perfusion and diffusion studies, to support diagnostic decision-making, particularly in acute stroke care. Its methodology involves automated processing of DICOM images through various modules, leveraging algorithms to quantify parameters like tissue perfusion and blood volume, and enabling qualitative assessment of cerebral hemodynamics from C-arm CT in the angiography suite.

Rapid, developed by iSchemaView Inc., is an advanced medical image management and processing software system designed for use by trained professionals, including physicians and medical technicians, to aid in diagnosis for adult patients. The software, operable on standard or virtual platforms, processes DICOM-compliant images from CT and MRI scanners to facilitate viewing, quantification, analysis, and reporting of tissue changes. Its core functionality encompasses a suite of modules for various imaging modalities such as CT Perfusion (CTP), CT Angiography (CTA), C-arm CT Perfusion, MRI Diffusion Weighted Imaging (DWI), and dynamic contrast-enhanced imaging. The system aims to streamline complex image processing tasks by automatically identifying scanning modalities and applying suitable processing modules, providing tools for volumetric analysis, time-intensity plotting, and mismatch measurements. Key applications of the Rapid software include aiding in the selection of acute stroke patients for endovascular thrombectomy using CT and MR perfusion data, and qualitatively assessing cerebral hemodynamics in the angiography suite via C-arm CT Perfusion. The system also generates NCCT maps for hypodense/hyperdense tissue and visualizes water diffusion properties through its DWI module. Technologically, Rapid functions as a Software as a Medical Device (SaMD), typically involving a Rapid Server (physical or virtual) connected within a hospital's network. It supports various image analysis methods including CTP/MRP/C-arm CTP, CTA, ASPECTS, ICH, LVO, and NCCT Stroke. The system's architecture includes secure data handling, with an iSchemaView Server providing a central, encrypted repository for data and facilitating secure connections. Phantom validation testing has confirmed its ability to accurately represent key processing parameters, including for the newly added C-arm CT perfusion capability, which provides qualitative data.

AI Regulatory Concerns

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• Q1. What are the specific quantitative thresholds and imaging criteria used by Rapid CT Perfusion and MR Perfusion modules to aid in the selection of acute stroke patients for thrombectomy?; How does the qualitative assessment of cerebral hemodynamics using Rapid C-arm CT Perfusion compare in diagnostic utility and limitations to quantitative methods available from conventional CT or MR perfusion in non-angiography settings?; What is the typical processing time for a complete analysis of CTP, CTA, and DWI datasets for an acute stroke patient, and how does this integrate into time-critical stroke workflows?; Can the Dynamic Analysis Module be customized to calculate novel or research-specific perfusion and permeability parameters beyond standard tissue flow and blood volume?; What are the differences in image processing algorithms and outputs between the standard CT Perfusion module and the C-arm CT Perfusion module, particularly concerning the handling of temporal resolution and potential artifacts specific to C-arm acquisitions?