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FDA clears first AI-powered MRI-derived breast cancer recurrence risk tool

FDA clears first AI-powered MRI-derived breast cancer recurrence risk tool

New Capabilities

SimBioSys's TumorSight Risk gives five- and ten-year recurrence estimates from a routine breast MRI, before surgery

September 25th, 2026: FDA clears TumorSight Risk

Overview

Updated Oct 19

The Food and Drug Administration cleared TumorSight Risk, the first AI tool that estimates breast cancer recurrence from an MRI a patient already has. SimBioSys's software turns routine MRI, pathology and clinical data into five- and ten-year recurrence estimates, available before surgery.

In a 2,129-patient study, five-year recurrence-free survival was 95.5% for patients the tool ranked low-risk and 89.6% for those ranked high-risk; at ten years, 88.9% and 69.6%. The score stayed linked to recurrence after adjusting for stage, grade, age, race and treatment. The clearance covers a prognostic tool, not proof that it improves outcomes or predicts who benefits from chemotherapy.

Why it matters

For women with early-stage breast cancer, this could mean faster, cheaper recurrence risk insight that helps decide on chemotherapy or extended endocrine therapy.

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Key Indicators

2,129
Patients in validation study
Multi-institutional study from Mayo Clinic, Emory, Stanford, and Mercy Medical Cedar Rapids.
3.3x
Recurrence risk, high vs. low
High-risk patients had 3.3-fold greater recurrence risk than low-risk patients.
22%
Risk increase per 10-point score rise
Each 10-point increase in the 0-100 score raised relative recurrence risk by 22%.
97%
Negative predictive value at 5 years
97.0% of patients the tool ranked low-risk had no recurrence within five years; the 10-year figure was 91.4%.
13.6%
5-year risk, top score band
Patients scoring 58-100 on the 0-100 scale; the lowest band, 0-10, had a 2.2% five-year risk.
75%
Share of US breast cancers targeted
HR+, HER2-negative early-stage disease is about 75% of US breast cancers.

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People Involved

SS
Stacey Stevens
President and CEO of SimBioSys
Leading the company through the FDA clearance
PS
Poornima Saha
Breast medical oncologist at Endeavor Health
Independent clinician commenting on the tool

Organizations Involved

SimBioSys
SimBioSys
AI precision medicine company
Developer of TumorSight Risk

Chicago-based AI company that develops software to analyze medical imaging for cancer treatment planning.
U.S. Food and Drug Administration
U.S. Food and Drug Administration
Federal regulator
Granted 510(k) clearance

The US Food and Drug Administration regulates medical devices, including AI-based software.

Timeline

2023 September 2026

4 events Latest: September 25th, 2026 · 2 months ago
Tap a bar to jump to that date

  1. FDA clears TumorSight Risk

    Latest Regulatory

    FDA grants 510(k) clearance (decision dated Sept. 25 in the FDA database), making it the first AI-powered MRI-derived recurrence risk tool for breast cancer. SimBioSys announced the clearance on Oct. 15.

  2. SimBioSys files 510(k) for TumorSight Risk

    Regulatory

    Company submits application K260023 to the FDA for the MRI-derived recurrence risk tool.

  3. Validation study presented at ASCO

    Research

    Results from 2,129 patients across four institutions shown at the ASCO Annual Meeting.

  4. FDA clears TumorSight Viz

    Regulatory

    SimBioSys's first FDA clearance, the 3D tumor visualization platform that TumorSight Risk builds on.

Scenarios

1

TumorSight Risk becomes a standard pre-surgery tool

Likely Resolves by End of 2027

Discussed by: SimBioSys leadership and breast oncologists quoted in coverage

Major cancer centers adopt the tool for pre-surgery treatment planning. It becomes a routine complement to genomic testing, particularly for patients where genomic assays are less validated, such as premenopausal and lymph node-positive women.

2

Reimbursement and cost barriers slow adoption

Possible Resolves by End of 2027

Discussed by: Healthcare analysts and oncologists concerned about added cost

Without clear insurance coverage, hospitals may be slow to adopt. The tool adds a new cost in a care pathway already using genomic tests, and its clinical utility beyond existing methods will need to be demonstrated in practice.

3

Competing MRI-based recurrence tools reach the market

Possible Resolves by End of 2027

Discussed by: Industry observers tracking AI/ML FDA clearances

Rivals file 510(k)s for similar MRI-derived prognostic tools, eroding TumorSight Risk's first-mover advantage. The FDA's growing comfort with AI prognostic tools, shown by clearances like ArteraAI Prostate, makes this path more likely.

Historical Context

2 moments from history that rhyme with this story — and how they unfolded.

2004

Oncotype DX (2004)

Genomic Health launched Oncotype DX, a test that analyzes the expression of 21 genes in tumor tissue to predict breast cancer recurrence and chemotherapy benefit. It was validated through large clinical trials and became a standard of care for early-stage breast cancer.

Then

Oncologists gained a tissue-based recurrence score that helped decide whether chemotherapy was worth its side effects.

Now

Genomic assays became the reference standard for recurrence risk, but they require tissue shipment, cost thousands of dollars, and have fewer validated options for some patient groups.

Why this matters now

TumorSight Risk is designed to complement genomic assays like Oncotype DX with an imaging-based estimate that is faster, cheaper, and available before surgery.

July 2025

ArteraAI Prostate (2025)

The FDA cleared ArteraAI Prostate, the first AI-based prognostic tool in oncology, which analyzes digitized pathology slides to predict treatment outcomes for prostate cancer patients.

Then

The clearance established a regulatory path for AI prognostic tools that combine imaging analysis with clinical data.

Now

It signaled the FDA's willingness to clear AI tools that inform treatment decisions, paving the way for similar tools in other cancers.

Why this matters now

ArteraAI Prostate set the regulatory precedent that TumorSight Risk followed, and its clearance shows the FDA's growing comfort with AI-based cancer prognosis.

Sources

(10)
+4
PR Newswire US Food and Drug Administration Good Morning America Innolitics SimBioSys EconoTimes Innolitics ASCO AI in Oncology ITN Online OncoDaily