Galen Second Read caught prostate cancers missed on a first read

In FDA's review of Galen Second Read, pathologists' sensitivity rose from 90.5% to 93.9% and specificity fell from 91.1% to 87.9%. It flagged 46 cases of cancer or atypia among 347 called benign.

  • 2 an organization

    With the software, pathologists' sensitivity rose from 90.5% to 93.9% while their specificity fell from 91.1% to 87.9%.

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

Status
Reported benefit.
Evidence

foundstudiedreportedclaimed

An independent regulatory document supports the benefit.

Compared with

The same 12 pathologists reading the same cases without the software. Measured.

Without the system
Sensitivity 90.5%, specificity 91.1%
With it
Sensitivity 93.9%, specificity 87.9%
The system’s part
In AIDER-1 each pathologist read every case with and without the software in random order, with a two-week washout, so the change in calls is attributed to the software.
Limits
Not yet checked.
Costs and harms
Not yet checked.
Later
Not yet checked.

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Benefit type
Improved Task Accuracy
System
Galen Second Read
Made by
Ibex Medical Analytics Ltd.
Used by
Ibex Medical Analytics (AIDER-2 study at three sites and AIDER-1 reader study with 12 pathologists at four sites)
Where
Pathology sites in the United States, with one site outside the US in each study
Stage
Tested in a laboratory
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. 510(k) substantial equivalence determination decision summary for Galen Second Read (K241232). Cleared 2025-01-24.

    The AIDER-1 clinical study demonstrated a statistically significant improvement in sensitivity of 3.5% with 95%CI: (2.3%; 4.5%) and statistically significant decrease in specificity of –3.2% with 95%CI: (-4.3%; -1.9%).

Details

AI system

Reported configuration

3.1-US

Workflow

Slides were scanned on a Philips Ultra Fast Scanner at 40x magnification. The software analyzed only cases that a pathologist had already diagnosed as benign.

Follow-up

Conditions for replication

A pathologist makes the final diagnosis after reviewing the flagged slides. The slides are H&E-stained prostate core needle biopsies.

Entry details

Sector

Healthcare.

Purpose

Ibex Medical Analytics built Galen Second Read to identify prostate biopsy cases first diagnosed as benign for further review by a pathologist.

Not yet checked: model, provider, role, configuration, inputs and outputs, autonomy, human oversight, 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). Galen Second Read caught prostate cancers missed on a first read (AIBD-0801). Artificial Intelligence Benefits Database, edition of 31 October 2026. https://petervartanian.xyz/aibd/records/AIBD-0801.html (archived at https://doi.org/10.7910/DVN/AADSII, version 4.0)

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