TumorSight Viz

by SimBioSys · Based in United States → — An AI-driven precision medicine company revolutionizing how cancer is understood and treated.

General Surgery Oncology Radiology

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Subscription-based

Regulatory Status Disclosed

Overview

TumorSight Viz by SimBioSys is an AI-powered, cloud-based 3D visualization and image processing platform designed to assist in preoperative planning for early-stage breast cancer patients. The software is FDA-cleared to process standard dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) studies, converting traditional 2D scans into interactive, spatial 3D models.

The platform is primarily built for breast surgeons, surgical oncologists, and multidisciplinary clinical teams operating in hospital and outpatient surgical settings. It serves as a clinical decision support tool prior to surgical interventions, such as breast-conserving surgery or mastectomies.

Workflow Integration & Capabilities:

Automated Image Transfer: Integrates directly with hospital Picture Archiving and Communication Systems (PACS) to automate DICOM image transfers, minimizing manual administrative tasks.
AI-Driven Segmentation: Automatically segments the tumor alongside surrounding anatomical structures, including fibroglandular tissue, adipose tissue, skin, blood vessels, and the chest wall.
Quantitative Clinical Metrics: Calculates key physical measurements, such as total tumor volume, tumor-to-breast volume ratios, and exact distances from the tumor to critical landmarks like the skin, chest wall, and nipple.
Surgical Margin Planning: Features a convex hull tool that allows surgeons to visualize hypothetical resection margins to guide surgical approaches.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

3D spatial visualizations of breast cancer
Converts standard breast MRI into intuitive 3D models
Automatic segmentation and quantification of tumor characteristics
Calculates tumor volume and distances to anatomical features
Supports breast conservation surgery planning
Enables shared decision-making between surgeon and patient
Research-use application to convert prone imaging to supine operative position
AI-driven segmentation for enhanced preoperative planning
Provides same-day results and insights
PACS connectivity for automated image transfer

Use Cases

Preoperative planning for breast cancer surgery
Enhancing surgical decision-making (margins, incisions, reconstruction)
Patient education and shared decision-making
Determining breast conservation versus mastectomy options
Improving consistency, precision, and efficiency in breast cancer surgery
Research applications in tumor modeling and visualization

What Physicians Need to Know

Key Capabilities

Provides 3D spatial visualization and AI-driven automatic segmentation of breast tumors and surrounding anatomical structures (fibroglandular, adipose tissue, skin, chest wall, blood vessels). Offers accurate tumor and breast volume measurements, along with critical tumor-to-landmark distances (e.g., tumor-to-nipple). Includes Clinical Decision Support (CDS) features to visualize hypothetical resection margins (convex hulls) and supports the evaluation of various surgical options. A research-use application allows conversion of prone MRI imaging to a supine position.

Clinical Utility

Enhances preoperative planning by providing a clearer, 3D understanding of tumor anatomy, leading to more informed decisions regarding margins, incisions, and reconstruction. It supports breast-conserving surgery when appropriate, potentially improving cosmetic and functional outcomes. The tool facilitates timely, informed patient conversations, fostering trust and understanding, and aims to improve consistency, precision, and efficiency in breast cancer surgery.

Integration Options

Integrates with standard imaging pipelines, accepting routine breast MRIs as input. It features Picture Archiving and Communication System (PACS) connectivity to automate image transfer and reduce manual tasks, designed to fit seamlessly into existing radiology and surgical workflows. There are ongoing explorations for integration with Augmented Reality (AR) platforms like Magic Leap 2 for immersive viewing.

Compliance Status

FDA 510(k) cleared. The platform has received multiple clearances, with its latest being the third FDA 510(k) clearance for TumorSight Viz 1.3, expanding its capabilities for breast cancer surgery.

Pricing Model

The specific pricing model for TumorSight Viz is not explicitly detailed in the provided information.

User Experience

Features an intuitive design and is reported to be easy to use, integrating naturally into existing workflows. Surgeons generally become comfortable with the system after a short onboarding session. An internal survey indicated that 70% of surgeons rated TumorSight Viz as valuable or very valuable, particularly for complex cases like multi-focal/multi-centric tumors or those near critical structures.

Support Quality

Supported by guided training and ongoing clinical support provided by the SimBioSys team.

Implementation Complexity

Designed for simplified implementation into surgical workflows. Its integration with standard imaging pipelines and new PACS connectivity aims to automate image transfer and reduce manual tasks, thereby minimizing disruption and improving efficiency.

Evidence Base

A clinically validated platform with a growing body of evidence. Studies have demonstrated strong concordance with radiologist annotations, accurate delineation of tumor size relative to breast volume, and consistent performance across over 1,600 retrospective cases from more than nine institutions. Findings have been published in NPJ Breast Cancer, and formal outcome studies are underway. The platform aligns with updated NCCN guidelines for individualized, data-supported treatment planning.

Physician Tip

Leverage the 3D visualizations for comprehensive preoperative planning, especially for complex cases like multifocal tumors, to optimize surgical margins and approaches. Utilize the tool for enhanced patient education and shared decision-making, as the 3D models can help patients better visualize their condition and treatment options. Integrate TumorSight Viz early in the planning process to inform discussions with radiology, plastics, and oncology teams, fostering a collaborative approach. Pay attention to the tumor-to-landmark measurements and volume calculations to guide decisions on breast-conserving surgery versus mastectomy and to plan for oncoplastic procedures.

TumorSight Viz is designed for seamless integration with existing PACS systems and standard MRI imaging workflows, aiming to minimize disruption to current clinical processes. Future integrations are exploring augmented reality platforms for even more immersive surgical planning experiences.

At a glance

Pricing Subscription-based

Deployment Cloud Based Platform

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Details

Category	Oncology AI
Pricing	Subscription-based — Contact vendor for details; different tiers based on specific tool utilized.
Deployment	Cloud-based platform
Compliance
BAA Available	Unknown AI-estimated
HIPAA Compliant	Unknown AI-estimated
FDA Status	1 AI-estimated TumorSight Viz has received multiple FDA 510(k) clearances, with the first clearance in January 2024. The latest clearance (version 1.3) expands its ability to convert standard breast MRI into 3D visualizations to support more informed and individualized surgical decision-making in breast cancer. The FDA 510(k) number K251766 refers to TumorSight Viz as 'Automated Radiological Image Processing Software'.
Integrations
EHR	Not specified
Specialties	General Surgery, Oncology, Radiology

What the Web Says

TumorSight Viz is an AI-powered, FDA-cleared platform that converts standard breast MRI into detailed 3D visualizations for surgical planning in breast cancer. It aims to enhance precision in surgery, improve patient understanding, and facilitate collaborative decision-making between surgeons and patients. The platform has received positive feedback from surgeons, with 70% rating it as valuable or very valuable in internal surveys.

Overall: Positive

Strengths

Provides 3D spatial visualizations of breast cancer, aiding in surgical planning.
Automatically identifies tumor tissue and calculates breast/tumor volume and distances to anatomical features.
Enhances collaborative decision-making between surgeons and patients.
May minimize surgery severity and improve patient quality of life by providing additional information for breast conservation options.
Demonstrates strong concordance with radiologist annotations and accurate delineation of tumor size.
Features PACS connectivity to automate image transfer and reduce manual tasks, improving efficiency.

Limitations

Patient management decisions should not be made based solely on the results of TumorSight Viz, requiring clinician review.
The study cohort for validation was limited to subjects eligible for neoadjuvant chemotherapy, which might affect generalizability.
No specific reviews from G2, Capterra, Reddit, or independent tech reviewers were found, limiting external perspectives beyond company-provided information and medical publications.

Based on reviews from: SimBioSys, FDA, PR Newswire, Ricoh USA, ResearchGate, Medical AI Tools for Physicians

Last updated: 2026-07-19

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Press & Coverage

Targeted Oncology

FDA Clears AI-Based Visualization Software for Surgical Breast Cancer Care

The FDA has granted 510(k) clearance to TumorSightu2122 Viz, an AI-based tool, to convert standard breast MRI into 3D visualizations for breast cancer surgery. Version 1.3 expands capabilities, offering superior AI-driven segmentation and same-day results to aid preoperative planning and patient discussions.

2025-07

PR Newswire

SimBioSys Secures Third FDA Clearance for TumorSightu2122 Viz, Advancing AI-Powered Precision Surgery in Breast Cancer Care

SimBioSys announced its third FDA 510(k) clearance for TumorSightu2122 Viz, enhancing its ability to convert standard breast MRI into intuitive 3D visualizations for individualized surgical decision-making. The latest version, 1.3, introduces improved AI-driven segmentation, faster case processing, and streamlined workflow integration with PACS connectivity.

2025-07

MD+DI Online

SimBioSys Earns 3rd FDA OK for TumorSight Viz AI Breast Cancer Tool

SimBioSys has received its third FDA 510(k) clearance for TumorSight Viz, a cloud-based digital medicine platform for breast cancer. The newly cleared TumorSight Viz 1.3 software improves accuracy in lesion segmentation and tumor volume estimation, providing rapid insights for surgical planning.

2025-07

SimBioSys

SimBioSys and Ricoh 3D for Healthcare announce strategic alliance expanding access to TumorSightu2122 Viz for breast cancer surgery

SimBioSys and Ricoh 3D for Healthcare have formed a strategic alliance to broaden market access to TumorSightu2122 Viz, SimBioSys' FDA-cleared 3D surgical visualization platform for breast cancer. This partnership aims to accelerate the adoption of AI-powered surgical visualization tools in breast cancer care.

2025-08

BioSpace

SimBioSys and Ricoh 3D for Healthcare to Spotlight AI-Powered 3D Visualization in Webinar Featuring Clinical Use of TumorSightu2122 Viz

SimBioSys and Ricoh 3D for Healthcare announced an upcoming educational webinar highlighting the real-world clinical use of TumorSightu2122 Viz. This webinar will showcase how the FDA-cleared 3D surgical visualization platform aids surgeons in evaluating breast-conserving options and engaging patients.

2025-12

AuntMinnie

U.S. FDA clears latest version of SimBioSys's breast cancer platform

Chicago-based AI developer SimBioSys has received FDA clearance for the latest version of its MRI breast cancer platform, TumorSight Viz. Version 1.3 includes improved AI-driven segmentation, faster case processing, and new PACS connectivity.

2025-07

npj Breast Cancer (via PMC)

Performance of an AI-powered visualization software platform for precision surgery in breast cancer patients

This peer-reviewed article evaluates TumorSight Viz, a medical device software platform that provides detailed 3D renderings of tumors for clinical decision-making in breast cancer. The study demonstrates that TumorSight Viz segmentations and surgical margin visualizations are comparable to expert radiologists.

2024-11

PR Newswire

SimBioSys Achieves Second FDA Clearance for TumorSightu2122 Viz and Introduces TumorSightu2122 Clinical Decision Support for Breast Cancer Surgery

SimBioSys announced its second FDA 510(k) clearance for TumorSightu2122 Viz, expanding its use for breast surgeons. The updated platform features enhanced AI-driven tumor segmentation, rapid image processing, PACS connectivity, and a new clinical decision support (CDS) feature.

2024-11