SimBioSys®, a pioneering TechBio company at the forefront of digital precision medicine for cancer care, has officially secured its second FDA 510(k) clearance for TumorSight™ Viz to expand its use among breast surgeons across the US.
According to certain reports, the stated solution can now process images with AI in a matter of minutes, and at the same time, integrate enhanced AI-driven tumor segmentation, Not just that, it also has a first of its kind clinical decision support (CDS) feature which informs providers of evidence-based treatment options. More on the same would reveal how TumorSight Viz should now be able to enhance treatment planning, while simultaneously boasting the means to optimize oncologists’ decisions for early-stage breast cancer patients’ surgery.
Talk about what the given approval might mean on a slightly deeper level, it is likely, for instance, to conceive enhanced AI-driven segmentation. In essence, leveraging AI, TumorSight Viz can seamlessly deliver accurate and efficient tumor and tissue segmentation so to enable detailed 3D spatial visualization and support treatment planning.
We referred to the solution’s CDS application facility and how it can provide data-driven insights to aid in breast surgeons’ planning and preparation for surgery, but what we haven’t touched upon yet is its bid to offer Direct MRI Access via a PACS system. Basically, TumorSight Viz now supports integration with middleware software, as well as direct to PACS systems. This it does to enable access of MRI images for analysis within the TumorSight platform and seamless fit into the clinician workflow.
“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.”
To understand the significance of such a development, we must take into how the recent FDA mandate now requires breast density reporting for all women to undergo a mammogram, causing the demand for MRI as a supplementary screening tool to rise by a substantial margin.
Against that, TumorSight Viz brings to the fore a powerful platform which is well-equipped to visualize MRI data in 3D and support breast surgeons in tailoring treatment decisions as per each patient’s unique tumor characteristics. You see, the solution can make it possible for healthcare providers to access advanced imaging insights and best practices for breast-conserving surgeries, aligning with updated NCCN guidelines and promoting minimally invasive approaches when feasible and desired by patients.
In case you weren’t aware, recent NCCN guideline updates emphasize the importance of individualized, data-supported treatment planning to support breast reconstruction and oncoplastic surgery as safe and effective options for eligible patients.
TumorSight Viz address this need big time through better volume and anatomical measurements that assist surgeons in utilizing volume displacement techniques with a goal to achieve optimal cosmetic and functional outcomes. Furthermore, surgeons are now also better positioned with output measurements that are more complementary of the standard of care guidelines to help plan lumpectomies more precisely. The stated system, as a whole, supports, both effective tumor removal and preservation of breast appearance.
Another detail relaying the importance of this development is rooted in data that reveals how breast cancer affects more than 300,000 patients across U.S. on an annual basis.
“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,” said Dr. Freya Schnabel from NYU.
