AIBOLIT 3D+

Aibolit 3D+ is a web-based medical imaging software that transforms CT DICOM data into interactive 3D anatomical models to aid in preoperative surgical planning, training, and intraoperative visualization. The system employs a radiologist-driven workflow, incorporating features like organ segmentation, transparent viewing, and AI-assisted annotation, to provide clinicians with enhanced spatial understanding of patient anatomy.

Aibolit 3D+ is a medical imaging software system designed for the processing, review, analysis, and communication of multi-dimensional digital images acquired from CT imaging devices. Its primary purpose is to support healthcare professionals in preoperative surgical planning, training, patient education, and as an intraoperative display tool, ultimately assisting clinicians in making final patient management decisions. The system operates as a web-based, stand-alone application that processes DICOM CT images to generate interactive 3D anatomical models. These models can be manipulated for viewing from various perspectives, offering features like transparent views of structures, identification of artifacts such as ducts, vessels, lesions, and entrapped calcifications, and differential coloration for highlighting regions of interest. The scientific basis of Aibolit 3D+ involves advanced image processing to convert standard CT scans into detailed 3D visualizations that can be manipulated for viewing, including features like organ segmentation, dimensional and volume references, multi-axis image rotation, organ transparency, and organ retraction animation. The workflow initiates with a physician uploading DICOM images and specifying desired anatomical segments. A radiologist then annotates these images, with the option of using AI/ML algorithms under their control and approval. Subsequently, an imaging technician generates a multi-axis rotatable image and retraction model. After a final review by the radiologist, the enhanced images, which can include organ structure dimensions, volume, labels, patient ID, and CT date, are made available to the requesting physician. This process aims to improve the surgeon's decision-making during planning, review, and conduct of surgical procedures by enhancing the identification of anatomical structures and their positional relationships.

AI Regulatory Concerns

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Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. How does the performance (e.g., accuracy, processing time) of Aibolit 3D+'s AI-assisted annotation compare to purely manual annotation by radiologists for various anatomical regions?; What specific quantitative benefits, such as reduction in surgical planning time or improvement in anatomical landmark identification accuracy, have been observed with the use of Aibolit 3D+ compared to standard 2D CT review?; Can Aibolit 3D+ integrate with other surgical navigation or robotic systems, and what is the process for exporting models for such use?; What are the limitations of the "organ retraction animation" feature, particularly in complex cases with significant adhesions or anatomical variations?; How does the system ensure the fidelity and accuracy of the 3D models, especially concerning measurements of critical structures like vessels or tumor margins, across different CT scanner protocols?