MarginProbe helped surgeons remove cancer left at lumpectomy margins

In a randomized trial that FDA reviewed, MarginProbe raised complete re-excision of positive margins from 22.4% to 71.8%. A 5-point drop in re-operations was not statistically significant.

  • 2 an organization

    Surgeons in the device arm achieved complete re-excision of positive margins in 71.8% of patients who had them, against 22.4% in the control arm.

  • Not rated a person

    Re-operations fell from 25.8% to 20.8%, a difference that was not statistically significant.

Depth runs from 1, a convenience or time saved, to 5, a life or a livelihood preserved.

Status
Reported and intended benefits.
Evidence

foundstudiedreportedclaimed

An independent regulatory document supports the benefit.

Compared with

Standard care in the randomized control arm. Measured.

Without the system
25.8% of patients had a further excision (94/298)
With it
20.8% (82/298)
The system’s part
Not isolated. Patients were randomized, but FDA reviewers write that the contribution of the device was not assessed, because surgeons did not record why they took each extra shave. The decision line of the classification algorithm was set and tuned on tissue measurements matched to pathology, a simple classifier fitted to data.
Limits
Not yet checked.
Costs and harms
Not yet checked.
Later
Not yet checked.

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Benefit type
Improved Task Accuracy
System
MarginProbe System
Made by
Dune Medical Devices, Inc.
Used by
Surgical sites in the randomized trial in Israel and the United States (596 women undergoing lumpectomy)
Where
Israel and United States
Stage
In a pilot
Date
, when the source was published
Kind
Aggregate result
Broad benefit
Identifying Objects, Actions, and Events
Collections
Scrutiny and findings, Cross-border records
Last revised
31 October 2026

Sources

  1. Regulatory document, by authors with no tie to the system.

    U.S. Food and Drug Administration, Center for Devices and Radiological Health. Summary of Safety and Effectiveness Data (SSED), P110014: Dune Medical Devices MarginProbe System. Approved 2012-12-27.

    The results from the pivotal clinical study indicate that the device when used as an adjunctive tool for identification of cancerous tissue at the margins (≤ 1mm) of the ex-vivo lumpectomy specimen following primary excision of breast cancer, there was a 5 percentage point reduction in re-operation.

Details

AI system

Workflow

Surgeons probed the margins of the main specimen right after excision. Surgeons completed a training phase before they randomized patients.

Follow-up

Conditions for replication

The patient has previously diagnosed breast cancer and undergoes lumpectomy. The surgeon does not routinely shave every cavity margin in the same operation.

Entry details

Sector

Healthcare.

Purpose

Dune Medical Devices built the MarginProbe System to help surgeons identify cancerous tissue at the margins of the main lumpectomy specimen during surgery.

Not yet checked: model, release, provider, role, configuration, inputs and outputs, autonomy, human oversight, AI contribution, beneficiaries, reach, distribution and access, duration, every measurement question, every money question, ownership and control, dependencies, cross-border connections, geopolitical implications, replication attempts, availability, institutional decision, grounds, action and result, success criterion, every evidence question, observed or intended, alternative assessments, related entries, other identifiers, category mappings.

Cite this record

Peter H. Vartanian. (2026). MarginProbe helped surgeons remove cancer left at lumpectomy margins (AIBD-0794). Artificial Intelligence Benefits Database, edition of 31 October 2026. https://petervartanian.xyz/aibd/records/AIBD-0794.html (archived at https://doi.org/10.7910/DVN/AADSII, version 4.0)

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