SimBioSys has obtained its third US Food and Drug Administration’s (FDA) 510(k) clearance for TumorSight Viz, an artificial intelligence (AI) platform designed to enhance precision in breast cancer surgery.
The latest version, TumorSight Viz 1.3, converts standard breast MRI scans into 3D visualisations that aid in surgical decision-making.
TumorSight Viz offers surgical oncologists 3D spatial visualisations using standard-of-care medical imaging, such as dynamic contrast-enhanced magnetic resonance imaging (DCE MRI). It provides critical measurements important for procedures like Breast Conservation Surgery.
The platform automatically generates ‘digital twin’ renderings that clearly display the tumour in relation to auto-segmented anatomical structures, including skin, vessels, chest, fat, and gland, aiming to improve surgical outcomes through greater precision and efficiency.
Its new capabilities include improved AI-driven segmentation for better lesion and tumour volume estimation, which enhances preoperative planning. It processes cases more rapidly, delivering results within minutes to facilitate timely patient discussions, said SimBioSys.
Additionally, the updated version is said to integrate seamlessly with PACS systems, streamlining workflow by automating image transfers.
SimBioSys claimed that TumorSight Viz addresses the need for precise surgical planning in breast cancer care by transforming complex MRI data into clear, anatomy-specific insights. This enables surgeons to perform with greater consistency and personalisation, meeting rising expectations for precision and cosmetic outcomes.
SimBioSys president and CEO Stacey Stevens said: “This latest clearance represents a pivotal step forward in our mission to bring greater precision and progress in the fight against breast cancer.
“As the leading cancer diagnosed in women worldwide, breast cancer presents a complex and urgent challenge—demanding tools that enhance surgical clarity and enable more individualised care.
“TumorSight Viz 1.3 delivers a new level of intelligence and insight, helping surgeons see what’s possible with greater confidence and enabling care that’s truly aligned with each patient’s unique anatomy and goals.”
In November 2024, SimBioSys announced a second FDA clearance to widen the platform’s accessibility among US breast surgeons.
The previous update introduced faster image processing, advanced AI-driven segmentation, direct connectivity to PACS systems, and an innovative clinical decision support feature. This addition aims to optimise treatment planning and improve surgical decisions for early-stage breast cancer patients.
