by:
Dr. Janel Gordon, M.D., DipABOM, DipABLM
Posted: Oct 19, 2026 / 06:18 PM EST / Updated: Oct 19, 2026 / 06:20 PM EST
INDIANAPOLIS — A new AI tool could help doctors better predict whether breast cancer will return, and it’s now received FDA approval.
SimBioSys created TumorSight Risk, an AI-powered, MRI-derived, prognostic tool, using NVIDIA technology to assess breast cancer recurrence risk in individuals with early-stage hormone receptor-positive, HER2-negative breast cancer.
This specific type of cancer accounts for over 70% of breast cancer diagnoses in the United States.
FDA approval comes following a multi-site study of over 2,000 patients. TumorSight Risk can assess the risk of recurrence of the cancer at five and 10 years after diagnosis using data from breast MRI.
This is great news for the patients battling a new cancer diagnosis and fears of recurrence. Standard testing requires surgery for tissue samples and could take weeks to determine what the tool can do in a couple of hours prior to the patient having an operation. This information can then be used by a patient’s care team to develop a personalized treatment plan.
Information regarding insurance coverage is currently unavailable. Interested individuals should speak with their oncologist and cancer care team.
