By Stacey Stevens, President & CEO, SimBioSys
Every October, pink ribbons remind us of how far we’ve come in the fight against breast cancer — and how far we still have to go. Despite remarkable progress in awareness, screening, and treatment, breast cancer remains the most commonly diagnosed cancer among women worldwide. In 2025 alone, more than 316,000 women in the U.S. are expected to be diagnosed with invasive disease, and nearly 42,000 will lose their lives to it.
These numbers represent mothers, daughters, sisters, and friends — and they underscore why continued innovation is not optional. It’s essential.
At SimBioSys, our mission is to transform cancer care through AI-powered, image-based solutions that help clinicians see beyond the surface. And this Breast Cancer Awareness Month, we’re reflecting on a major milestone that embodies that mission: the recent FDA clearance of TumorSight Viz 1.3 in July. This achievement marked a pivotal step forward in the movement toward more personalized, precise surgical care—and we’re now seeing that progress begin to take hold in operating rooms and hospitals across the country.
A Clearer View for Smarter Surgery
Surgery is often the first and most critical step in a woman’s breast cancer journey. Yet for decades, surgical planning has relied on limited visualization, subjective interpretation, and incomplete information about the full extent of disease.
TumorSight Viz 1.3 changes that.
Built on advanced AI segmentation and spatial biophysics, TumorSight Viz transforms a standard breast MRI into a 3D digital model that allows surgeons to visualize the tumor and surrounding tissue in precise detail — helping them plan procedures that are both oncologically sound and cosmetically optimal.
The new version, cleared by the FDA this summer, delivers major improvements in performance, usability, and integration. It gives surgeons the ability to interpret complex MRI data in minutes and make more informed decisions about breast-conserving surgery, margins, and reconstruction options.
In the words of one of our clinical collaborators, Vincent Reid, MD, FACS, Mercy Cedar Rapids, “TumorSight Viz has transformed the way I plan breast surgeries — taking what was once more art than science and grounding it in precision.”
That’s exactly what we aim to achieve: moving from intuition to insight, from averages to individuals.
From Awareness to Action
Awareness saves lives when it’s coupled with access and advancement. While screening and early detection have driven mortality down nearly 40% over the past three decades, one in eight women will still develop breast cancer in her lifetime.
Behind those statistics lies an evolving landscape:
- Younger women are being diagnosed more frequently, with incidence rates rising about 1% per year.
- Black women continue to experience 38% higher mortality, despite similar rates of diagnosis.
- And too many patients still face repeat surgeries due to positive margins or uncertainty about tumor extent.
These gaps remind us that awareness alone is not enough — we need precision. Precision in detection, diagnosis, and surgical execution. Precision that empowers clinicians to preserve both life and quality of life.
TumorSight Viz was designed with this in mind: to make every decision better informed, every resection more precise, and every patient’s journey more personalized.
The Next Frontier in Personalized Cancer Care
At SimBioSys, we believe the future of cancer care lies in understanding not only what a tumor is, but where it is, how it behaves, and how best to treat it.
TumorSight Viz 1.3 represents the latest proof point in this vision. It’s the first in a growing suite of AI-driven solutions designed to personalize care at every stage. Our next product, TumorSight Risk, is advancing toward clinical validation and FDA submission—bringing the same image-based approach to help clinicians better assess recurrence risk and guide treatment decisions in breast cancer.
Together, these technologies create a foundation for precision oncology that goes beyond molecular data, integrating imaging, physics, and AI to give clinicians a multidimensional view of each patient’s disease.
A Month to Reflect — and Recommit
Breast Cancer Awareness Month is a time of remembrance and resilience. It’s also a time to ask ourselves what more we can do — as innovators, clinicians, policymakers, and advocates — to close the gap between what’s possible and what’s real.
For us at SimBioSys, that means continuing to deliver technologies that make complex information simple, actionable, and personal. It means building partnerships with leading cancer centers, health systems, and advocacy organizations that share our commitment to progress grounded in evidence. And it means ensuring that every woman, regardless of where she lives or the resources available to her, can benefit from innovations like TumorSight Viz.
We envision a future where every patient’s cancer is understood in full color, full context, and full dimension — where awareness is no longer the goal, but the foundation for action.
Because when we can truly see cancer — in all its complexity and individuality — we can finally begin to defeat it.
References:
- https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2025/2025-cancer-facts-and-figures-acs.pdf
- https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/breast-cancer-facts-and-figures/2024/breast-cancer-facts-and-figures-2024.pdf
- https://www.cancer.org/cancer/types/breast-cancer/about/how-common-is-breast-cancer.html
- https://hms.harvard.edu/news/breast-cancer-increasing-among-younger-women-latest-data-show
- https://www.bcrf.org/about-breast-cancer/breast-cancer-racial-disparities/
- https://www.cancer.org/cancer/types/breast-cancer/about/how-common-is-breast-cancer.html
- https://jamanetwork.com/journals/jama/fullarticle/1104931
