Galen Second Read
by Ibex Medical Analytics
· Based in Israel →
— Transforming cancer diagnostics with AI.
Contact for pricing
Regulatory Status Disclosed
Overview
Galen™ Second Read™, now known as Ibex Prostate Detect in the US, is a software-only device developed by Ibex Medical Analytics. It is designed to analyze scanned histopathology whole slide images (WSIs) from prostate core needle biopsies (PCNB) prepared from hematoxylin & eosin (H&E) stained formalin-fixed paraffin embedded (FFPE) tissue. The tool’s primary purpose is to identify cases initially diagnosed as benign for further review by a pathologist.
Utilizing advanced AI algorithms, Galen™ Second Read™ detects tissue morphology suspicious for prostate adenocarcinoma (AdC), providing case- and slide-level alerts which include heatmaps highlighting areas likely to contain cancer. This functionality acts as a crucial safety net, assisting pathologists in ensuring accurate and timely diagnoses, enhancing diagnostic accuracy, streamlining workflows, and ultimately improving patient outcomes. The platform is deployed globally in routine clinical use, supporting pathologists in managing increasing workloads and diagnostic complexities.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- AI-powered analysis of whole slide images (WSIs)
- Detection of prostate adenocarcinoma (AdC)
- Identification of potentially missed cancers
- Case- and slide-level alerts for suspicious findings
- Heatmaps to highlight areas likely to contain cancer
- Quality control system for pathology diagnoses
- Enhances diagnostic accuracy and consistency
- Streamlines pathology workflows and improves efficiency
- Cloud-hosted solution for accessibility
- Supports pathologists in managing increasing diagnostic workloads
Use Cases
- Second read system for prostate cancer diagnosis
- Quality control in pathology laboratories
- Assisting pathologists in identifying small and rare prostatic cancers
- Improving diagnostic accuracy and consistency in prostate biopsies
- Reducing turnaround times for prostate cancer diagnosis
- Empowering pathologists to manage increasing diagnostic workloads effectively
What Physicians Need to Know
Key Capabilities
Analyzes scanned histopathology whole slide images (WSIs) from H&E stained prostate core needle biopsies, identifying cases initially diagnosed as benign for further pathologist review. It detects tissue morphology suspicious for prostate adenocarcinoma (AdC), providing case- and slide-level alerts with heatmaps highlighting areas likely to contain cancer. The system supports detection and grading, including Gleason score, tumor size, and associated morphologies. It functions as a 'second read' quality control system, running in parallel to routine workflows.
Clinical Utility
Acts as a safety net against diagnostic errors, significantly improving accuracy and safety. In validation studies for prostate cancer, it identified 13% of missed cancer cases in cohorts initially diagnosed as benign. It demonstrates high accuracy in distinguishing benign from prostate adenocarcinoma (AUC 0.988) and in Gleason grading (AUC 0.901). The tool improves diagnostic efficiency, reducing time-to-diagnosis and overall turnaround times, and boosts pathologist productivity and confidence.
Integration Options
The solution is cloud-hosted and designed for integration with existing digital pathology infrastructure. It utilizes WSIs from various digital scanners (e.g., Philips Ultra Fast Scanner, 3DHISTECH P1000) and is ready for integration with scanning platforms, pathology workflow systems, and Laboratory Information Systems (LIS). Ibex has strategic partnerships with companies like Philips and Roche for integrated workflows, and the platform now supports DICOM.
Compliance Status
Ibex Prostate Detect (formerly Galen Second Read in the US) has received U.S. FDA 510(k) clearance for prostate cancer diagnosis. The broader Galen platform, including prostate, breast, and gastric solutions, is CE-IVD certified (per IVDR framework) and registered with regulatory bodies in the UK (MHRA), Australia (TGA), and Brazil (ANVISA). Other solutions within the Ibex platform may be Research Use Only (RUO) in the United States.
Pricing Model
Specific pricing models (e.g., subscription, per-case) are not publicly detailed. Customer feedback suggests it may be perceived as cost-prohibitive, indicating a commercial, likely enterprise-level, offering.
User Experience
Designed to run in parallel with pathologists' routine workflows, providing alerts and heatmaps to guide review. Users report improved interfaces, enhanced diagnostic confidence, and increased employee satisfaction. It is described as an 'AI assistant' that provides a higher safety net with minimal additional effort.
Support Quality
Customers have reported positive experiences with Ibex Medical Analytics, highlighting knowledgeable staff and timely support responses.
Implementation Complexity
Described as 'easy to deploy,' the system is cloud-hosted, reducing on-premise hardware management for the AI component. It requires existing digital pathology infrastructure (scanners for WSIs) and integration with current lab systems. AI deployment can also serve as a driver for full digital transformation of pathology labs.
Evidence Base
Supported by rigorous, blinded, multi-site clinical studies published in peer-reviewed journals (e.g., Lancet Digital Health, Modern Pathology, Pathology). Algorithms are trained on extensive datasets (e.g., >2 million image samples for prostate) from diverse sources, manually annotated by senior pathologists. Studies demonstrate a 99.6% positive predictive value for cancer heatmap accuracy in prostate, and a 13% rate of identifying missed cancers in initially benign prostate cases.
Physician Tip
For pathologists considering Galenu2122 Second Readu2122 (now Ibex Prostate Detect for prostate in the US), leverage its 'second read' capability as a robust quality control measure to catch missed cancers and improve diagnostic accuracy, particularly in challenging cases. Utilize the AI-generated heatmaps and alerts to efficiently focus your review on suspicious areas, enhancing workflow without replacing your expert judgment. Embrace the digital pathology workflow, as this AI tool thrives in a fully digitized environment, potentially leading to increased productivity and reduced turnaround times. Remember that while the prostate solution is FDA-cleared, verify the regulatory status for other tissue types or 'First Read' applications if considering broader use.
Galenu2122 Second Readu2122 is designed for seamless integration into existing digital pathology ecosystems. It is cloud-hosted and compatible with leading whole slide image (WSI) scanners (e.g., Philips Ultra Fast Scanner). The platform offers enhanced interoperability, including DICOM support, and can integrate with pathology workflow systems and Laboratory Information Systems (LIS) to streamline operations. Strategic partnerships with major healthcare technology providers like Philips and Roche further facilitate its adoption into diverse clinical environments.
Details
| Category | Oncology AI, Pathology AI |
| Pricing | Contact for pricing — Contact vendor for detailed pricing plans. |
| Deployment | Cloud-hosted |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated Galen™ Second Read™ received U.S. Food and Drug Administration (FDA) 510(k) clearance (K241232) on February 10, 2025, under its current name, Ibex Prostate Detect. It is cleared as an in vitro diagnostic medical device that uses AI to generate heatmaps identifying small and rare missed prostatic cancers, serving as a safety net for pathologists. |
| Integrations | |
| EHR | Not specified |
| Specialties | Oncology, Pathology, Urology |
Ratings & Reviews
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Press & Coverage
RadAI Slice
Galenu2122 Second Readu2122 | FDA Radiology AI Device - X-ray Interpreter
Galenu2122 Second Readu2122 is an FDA-approved software tool that analyzes digital images of prostate biopsy slides to identify regions suspicious for prostate cancer, flagging slides initially diagnosed as benign for further review. It uses a deep convolutional neural network and is intended to improve cancer detection by augmenting pathologist review, not replacing diagnosis.
2025-01
Innolitics
AI/ML in Digital Pathology and the Software-as-an-IVD Paradigm: 2026 Snapshot - Innolitics
This article discusses the regulatory landscape for AI/ML in digital pathology, highlighting that Ibex Medical Analytics' Galenu2122 Second Readu2122 (K241232, January 2025) was the first 510(k) to clear under the QPN product code, established by Paige Prostate. It emphasizes that De Novo authorizations are crucial for creating regulatory pathways for new pathology AI devices.
2026-04
accessdata.fda.gov
510(k) Premarket Notification - FDA
This FDA document details the 510(k) clearance for Galenu2122 Second Readu2122 (K241232) by Ibex Medical Analytics Ltd., approved on January 24, 2025. It specifies the device's intended use to analyze scanned histopathology whole slide images from prostate core needle biopsies to identify cases initially diagnosed as benign for further pathologist review.
2025-01
Journal of Clinical and Translational Pathology
A Lifecycle Framework for Digital Pathology Implementation: Integrating Infrastructure, Workflow, Regulatory Compliance, and AI Readiness for Sustainable Adoption
This peer-reviewed article highlights Ibex Galenu2122 Second Readu2122 as an FDA-cleared AI-powered digital pathology software algorithm designed to assist in detecting prostate cancer on whole-slide images. It discusses the importance of integrating AI systems with existing platforms and addressing practical implementation strategies for sustainable adoption in digital pathology.
2026-03
accessdata.fda.gov
510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
This FDA decision summary for K241232 confirms the substantial equivalence determination for Galenu2122 Second Readu2122 by Ibex Medical Analytics Ltd. It reiterates the device's intended use to analyze prostate core needle biopsy WSIs to flag cases initially diagnosed as benign for further pathologist review, providing case- and slide-level alerts with heatmaps.
2025-01
Innolitics
Definitive Guide to AI/ML SaMD Ground Truthing - Innolitics
This article, published in September 2025, references Galenu2122 Second Readu2122 (K241232, Ibex Medical Analytics Ltd.) in the context of ground truth determination for AI/ML SaMD. It notes that for Galenu2122 Second Readu2122, ground truth for a slide was determined by two independent expert pathologists, with a third pathologist reviewing in cases of disagreement to reach a majority rule.
2025-09
skywork.ai
Anu00e1lisis de Ibex Medical Analytics: La IA que Transforma el Diagnu00f3stico del Cu00e1ncer en 2025
This analysis from November 2025 states that Ibex Prostate Detect (Galenu2122 Second Readu2122) received 510(k) authorization (K241232) from the U.S. FDA in February 2025. It also mentions that Ibex's solutions for prostate, breast, and gastric cancer have IVDR certification in the EU and registration in the UK, Australia, and Brazil.
2025-11
Barco
MDPC-8127 - Digital pathology displays - Barco
Barco's product page for the MDPC-8127 digital pathology display lists FDA-cleared WSI systems compatible with it, including the Philips IntelliSite Pathology Solution with Philips Image Management System and Galenu2122 Second Readu2122 AI, cleared under K241232.
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Videos
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Frequently Asked Questions
Galenu2122 Second Readu2122, now known as Ibex Prostate Detect, functions as an AI-powered 'second read' system after a pathologist's initial review of whole slide images (WSIs) from prostate core needle biopsies. It analyzes scanned H&E-stained FFPE tissue slides, identifies suspicious areas for prostate adenocarcinoma, and provides case- and slide-level alerts with heatmaps to guide the pathologist to areas of interest for further review. This integration acts as a quality control tool, aiming to enhance diagnostic accuracy and efficiency without replacing the pathologist's final diagnosis.
In the United States, Galenu2122 Second Readu2122 (now Ibex Prostate Detect) has received FDA 510(k) clearance as a Class II medical device. This clearance indicates it is substantially equivalent to legally marketed predicate devices for assisting pathologists in identifying suspicious areas in prostate biopsies. For other tissue types like breast and gastric, Ibex's Galen solutions are CE-IVD certified in Europe and registered in other regions, but are for Research Use Only (RUO) in the United States unless specified otherwise.
A key limitation is that Galenu2122 Second Readu2122 is not intended for standalone diagnosis; its outputs are meant to assist and not replace the pathologist's assessment or preclude standard of care. It is specifically designed for prostate core needle biopsies and requires images digitized with compatible scanners, such as the Philips Ultra Fast Scanner. While highly accurate, no AI software can guarantee 100% accuracy, and human oversight remains crucial.
Galenu2122 Second Readu2122 is part of the broader Ibex Galen platform, which is a widely deployed AI-powered platform in pathology, offering solutions for prostate, breast, and gastric cancer. Other notable AI solutions in digital pathology include Paige Prostate and Paige Breast suites, and Aiforia, which also aim to enhance diagnostic accuracy and workflow efficiency. While specific comparative metrics can vary, Ibex's solutions have demonstrated high sensitivity and specificity in clinical validation studies.
Specific pricing details for Galenu2122 Second Readu2122 are not publicly disclosed, as is common for enterprise healthcare software. Generally, AI solutions like this are offered through licensing agreements, which may involve subscriptions, per-case fees, or institutional licenses. The cost would likely depend on the volume of cases, the scope of deployment, and the specific features integrated into a pathology lab's digital workflow.
Galenu2122 Second Readu2122 is explicitly designed as a 'second read' system and not a standalone diagnostic tool. Its purpose is to act as an AI assistant, providing alerts and heatmaps to pathologists to identify potential areas of concern that may have been missed during an initial review. The final diagnosis and clinical decision-making always remain the responsibility of the human pathologist.
Ibex Medical Analytics, the developer of Galenu2122 Second Readu2122, emphasizes its commitment to data security and privacy, holding certifications such as HITRUST, Cyber Essentials Plus, ISO 27001, and ISO 13485. These certifications indicate adherence to rigorous international standards for information security management and quality management systems for medical devices. The system typically processes de-identified whole slide images, and its cloud-hosted nature implies robust data protection protocols.
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| Last Verified: 2026-04-18 | First Added: 2026-04-18
Investors who backed Galen Second Read
Funded through the company that built this tool.
