MedPath

SimBioSys Receives FDA Clearance for AI-Enhanced TumorSight Viz with Clinical Decision Support

• SimBioSys has obtained its second FDA 510(k) clearance for TumorSight Viz, expanding its utility for breast surgeons with AI-driven enhancements. • The updated TumorSight Viz features rapid AI image processing, improved tumor segmentation, direct MRI access via PACS, and clinical decision support (CDS). • The CDS application is designed to aid treatment planning and optimize surgical decisions for early-stage breast cancer patients, aligning with NCCN guidelines. • TumorSight Viz aims to enhance precision surgery, reduce variability, and support breast conservation by providing advanced imaging insights and best practices.

SimBioSys, a TechBio company focused on digital precision medicine for cancer care, announced its second FDA 510(k) clearance for TumorSight Viz, designed to enhance breast cancer surgery planning. The updated platform now includes AI-driven tumor segmentation, rapid image processing, seamless MRI access, and a clinical decision support (CDS) feature.
The new CDS application is designed to provide data-driven insights for informing breast surgeons' planning and preparation for surgery. This aims to optimize treatment decisions for early-stage breast cancer patients undergoing surgery.

Enhanced Capabilities of TumorSight Viz

TumorSight Viz now incorporates several key enhancements:
  • Enhanced AI-Driven Segmentation: Utilizes AI to deliver accurate and efficient tumor and tissue segmentation, enabling detailed 3D spatial visualization to support treatment planning.
  • Clinical Decision Support (CDS) Application: The new CDS application is designed to provide data-driven insights for informing breast surgeons' planning and preparation for surgery.
  • Direct MRI Access via PACS Systems: TumorSight Viz now supports integration with middleware software as well as direct to PACS systems, allowing automated access to MRI images for analysis within the TumorSight platform and seamless fit into the clinician workflow.

Clinical Impact and Alignment with Guidelines

Recent NCCN guideline updates emphasize individualized, data-supported treatment planning to support breast reconstruction and oncoplastic surgery as safe and effective options for eligible patients. TumorSight Viz aligns with these recommendations by enabling volume and anatomical measurements that assist surgeons in utilizing volume displacement techniques with a goal to achieve optimal cosmetic and functional outcomes. With the new CDS capability, surgeons are now better equipped with output measurements from TumorSight Viz that are aligned with standard of care guidelines to help plan lumpectomies more precisely, supporting both effective tumor removal and preservation of breast appearance.
According to Dr. Freya Schnabel from NYU, "TumorSight Viz's clinical decision support functionality provides a groundbreaking resource to assist breast surgeons and oncologists in considering the best possible approaches for each patient, fostering shared decision-making and precision care."

Addressing Breast Cancer Care Needs

With over 300,000 patients affected by breast cancer annually in the U.S., SimBioSys's enhanced TumorSight platform aims to provide surgeons and patients with greater confidence in treatment decisions. The platform combines AI-driven visualizations with CDS tools to support more informed choices.
"This second FDA clearance represents a significant milestone in our mission to redefine precision medicine for cancer," said Barry Rosen, MD, Chief Medical Officer at SimBioSys. "TumorSight Viz's latest capabilities elevate the standard of breast cancer care by allowing surgeons to make more informed choices, moving closer to an era of precision surgery that reduces variation and supports breast conservation when desired by the patient."
Subscribe Icon

Stay Updated with Our Daily Newsletter

Get the latest pharmaceutical insights, research highlights, and industry updates delivered to your inbox every day.

Related Topics

SyntheticMR's SyMRI 15 Receives FDA 510(k) Clearance for Diagnostic Image Replacement

SyntheticMR's SyMRI 15 has received FDA 510(k) clearance, enabling its use for diagnostic image replacement of conventional MRI images.
The technology enhances MRI workflows by replacing conventional 3D imaging and providing tissue quantification.

FDA Approves Caris Life Sciences' MI Cancer Seek as Companion Diagnostic

The FDA has approved Caris Life Sciences' MI Cancer Seek, a comprehensive genomic profiling assay, as a companion diagnostic to identify cancer patients who may benefit from targeted therapies.
MI Cancer Seek utilizes simultaneous whole-exome and whole-transcriptome sequencing to analyze solid tumors, providing a comprehensive molecular blueprint in a single workflow.

Antelope Surgical Solutions Receives FDA IND Approval for Radiofluorescent Prostate Cancer Drug AS1986NS

Antelope Surgical Solutions has received FDA approval for its Investigational New Drug (IND), AS1986NS, a radiofluorescent drug targeting prostate cancer.
AS1986NS combines therapeutic radioisotopes and imaging agents with a fluorescent linker to enhance surgical precision by illuminating cancer margins.

Momentis Surgical Receives FDA Clearance for Second-Generation Anovo Robotic Surgery Platform

Momentis Surgical secured FDA 510(k) clearance for its second-generation Anovo robotic surgery platform, enhancing surgical capabilities through a single incision.
The upgraded Anovo system offers improved ergonomics, sensory feedback, and a video annotation layer to boost surgical team communication and learning.

MRIMath's AI-Powered Glioblastoma Tool Receives FDA Clearance

MRIMath LLC's _i_ 2Contour, an AI-powered tool for glioblastoma mapping and measurement, has received FDA clearance, allowing its marketing to potential customers.
The tool, co-developed by Rowan University and the University of Alabama at Birmingham, aims to improve efficiency and accuracy in tumor contouring, potentially reducing healthcare costs.

Caris Life Sciences' MI Cancer Seek Receives FDA Approval as Companion Diagnostic

Caris Life Sciences' MI Cancer Seek receives FDA approval as a companion diagnostic for targeted cancer therapies, benefiting both adult and pediatric patients.
MI Cancer Seek is the first assay to simultaneously use Whole Exome Sequencing (WES) and Whole Transcriptome Sequencing (WTS) with FDA-approved CDx indications.

AMC Health Receives FDA Clearance for AI-Powered Virtual Care Platform

AMC Health secured its third FDA 510(k) clearance for its virtual care and clinical decision support solution, marking it as a Class II medical device.
The clearance covers both the clinician dashboard and patient mobile app, enabling hospital-level, acute-care-at-home and continuous monitoring.

SimBioSys Receives FDA Clearance for TumorSight Viz with Clinical Decision Support for Breast Cancer Surgery

SimBioSys has obtained its second FDA 510(k) clearance for TumorSight Viz, expanding its utility for breast surgeons across the U.S.
The updated TumorSight Viz features AI-driven image processing, enhanced tumor segmentation, and direct MRI access via PACS systems.

Lumicell's LumiSystem Approved by FDA for Real-Time Breast Cancer Margin Assessment

The FDA has approved Lumicell's Direct Visualization System (LumiSystem) for intraoperative detection of cancerous tissue during lumpectomy surgery.
LumiSystem utilizes LUMIGHT, a novel fluorescent imaging agent, to identify residual tumor tissue in real-time, improving cancer resection.

Siemens Healthineers' Mammomat B.brilliant Receives FDA Approval for 3D Mammography

Siemens Healthineers' Mammomat B.brilliant has received FDA premarket approval for its tomosynthesis, enhancing breast imaging capabilities.
The system features PlatinumTomo technology, enabling rapid 3D image acquisition and reducing blur for more confident diagnoses.

Reference News

[1]
SimBioSys Achieves Second FDA Clearance for TumorSight™ Viz and ... - Longview News-Journal
news-journal.com · Nov 4, 2024

SimBioSys announces second FDA 510(k) clearance for TumorSight™ Viz, enhancing AI-driven tumor segmentation, direct MRI ...

© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy