The algorithm is ready. The question is whether our departments are.
As a pathologist, this feels to me like one of the most important moments our specialty has seen in decades.
Not because AI in pathology is new. Most academic departments have been thinking about computational pathology, biomarker quantification, and digital workflows for the last few years. What feels different now is that these tools are no longer being discussed primarily as research infrastructure or future possibilities. They are beginning to shape real treatment decisions.
Roche’s acquisition of PathAI is a significant signal that computational pathology has moved into the center of precision oncology strategy. The implications are larger than a single acquisition.
For years, pathologists have understood something that the broader healthcare ecosystem is only now fully appreciating: the biopsy is not simply supporting information for oncology care. Increasingly, it is where therapeutic eligibility is determined. As AI-enabled companion diagnostics become regulatory-grade clinical tools, pathology workflows are becoming directly connected to treatment access.
The emerging generation of ADCs and biomarker-driven therapies illustrates this clearly. Many of these treatments depend on increasingly nuanced tissue-based interpretation — quantitative scoring, spatial context, low-expression biomarkers, and patterns difficult to assess reproducibly through conventional microscopy alone. The pathologist remains central to interpretation, but the infrastructure around that interpretation is changing rapidly.
The Real Challenge: Deployment Over Development
An algorithm may be developed in a research environment, but it ultimately it has to function inside a clinical department. It must integrate into the daily workflow of pathologists, connect to existing laboratory systems, support regulatory and reporting requirements, and operate within institutions that have already made long-term infrastructure decisions. That deployment challenge is likely to become one of the defining questions of computational pathology over the next several years.
The academic medical centers where many of these patients are diagnosed are extraordinarily complex environments. They are simultaneously delivering clinical care, running trials, training residents and fellows, conducting translational research, supporting tumor boards, and managing large-scale image archives. Any AI companion diagnostic that hopes to achieve broad adoption will need to fit naturally into that ecosystem.
This is why workflow and institutional trust matter as much as algorithmic performance.
Pathology departments do not adopt infrastructure lightly. The systems that succeed over time are the ones that integrate cleanly into clinical operations, support a wide range of departmental needs, and earn confidence through years of daily use. In practice, the operational realities of pathology often determine whether even highly sophisticated technologies can meaningfully reach patients.
None of this diminishes what companies like Roche and PathAI have accomplished. The field needs validated, clinically deployable AI systems, and the progress being made is genuinely exciting for pathology and oncology alike.
But the next phase of the field may be defined less by whether these algorithms can be built, and more by how effectively they can be deployed within the institutions where precision oncology is actually practiced.
About the Author
Dr. Rajendra Singh is a Professor of Pathology at the University of Pennsylvania and co-founder of PathPresenter. He serves as a member of the Digital and Computational Pathology Committee of the CAP, Editorial Board of the WHO for Classification of tumors, 5th Edition and the Board of Digital Pathology Association.
Success Story: Expanding Access to Expert Cancer Diagnostics Through Digital Pathology Consultations
How The Ohio State University Comprehensive Cancer Center and PathPresenter enabled faster, more equitable second opinions across a regional network
In Brief
Access to subspecialty pathology expertise can significantly influence cancer diagnosis, treatment planning, and patient outcomes. Yet many regional and community hospitals lack the depth of specialized pathology resources available at large academic medical centers. The Ohio State University Comprehensive Cancer Center-Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC-James) addressed this gap by launching a digital pathology second opinion consult service across its James Cancer Network.
By partnering with PathPresenter, OSUCCC-James implemented a scalable, digital-first consultation workflow that eliminates traditional barriers such as physical slide transport, redundant data entry, and incompatible systems between institutions. At the center of this solution is PathPresenter’s clinical consultation module, enhanced with OCR-driven case accessioning that automatically extracts patient and case metadata directly from slide labels.
This innovation allows partner sites like Wooster Community Hospital to seamlessly submit cases for expert review without requiring a shared laboratory information system (LIS) or additional administrative burden. Subspecialist pathologists at OSUCCC-James can review cases within hours, dramatically reducing turnaround time compared to legacy workflows that could take days or weeks.
The result is a more connected, efficient, and equitable diagnostic network: one that extends advanced cancer expertise into local communities, improves clinical decision-making, and opens new pathways to clinical trials and specialized care.
The Goal: Bringing Specialist Expertise Closer to Patients
Accurate pathology interpretation is foundational to effective cancer care. Subtle diagnostic nuances can determine treatment pathways, eligibility for targeted therapies, and access to clinical trials. While academic centers like OSUCCC-James house world-class subspecialty expertise, many smaller or regional hospitals operate with limited pathology resources.
Recognizing this disparity, OSUCCC-James included remote pathology consultations in the services it offers through The James Cancer Network, a collaborative initiative designed to extend advanced oncology services beyond its main campus. Through this network, partner institutions gain access to training, research opportunities, and, critically, expert diagnostic support.
The need for consultations was clear. However, delivering this capability at scale required overcoming several operational and technical challenges. Among OSUCCC-James’s requirements for a successful solution:
Rapid turnaround times to support timely clinical decisions
Minimal logistical complexity, especially eliminating physical slide transport
Reduction of manual data entry and administrative overhead
Flexibility to integrate with diverse systems across partner institutions
A seamless and reliable experience for consulting pathologists
Strong privacy, security, and regulatory compliance
Scalability to support a growing network
Digital pathology was the obvious foundation, but implementing it effectively required more than simply digitizing slides.
The Challenge: Fragmented Systems and Inefficient Workflows
While digital pathology enables remote viewing of whole slide images (WSIs), the surrounding workflow, particularly case accessioning and data management, often remains fragmented.
In typical consultation workflows, when a regional hospital submits a case for consultation, there is plenty of work besides the actual slide scanning. Staff must create or export a case record from their local LIS, and often re-enter patient and case information into the receiving institution’s system.
This process introduces delays, increases the risk of transcription errors, and places additional strain on already limited staff resources. The problem is compounded when partner institutions use different LIS platforms or lack such systems altogether.
For OSUCCC-James, these inefficiencies posed a significant barrier to scaling their consultation program. They needed a solution that could:
Work across heterogeneous or absent LIS environments
Automate case creation without duplicating effort
Maintain data integrity and compliance
Fit naturally into existing clinical workflows
The Solution: PathPresenter’s Consultation Module with Automated Case Accessioning
To address these challenges, OSUCCC-James partnered with PathPresenter, leveraging a long-standing relationship built on educational, research, and clinical deployments of PathPresenter’s IMS.
PathPresenter’s platform already offered a robust, FDA-cleared clinical viewer and class-leading consultation capabilities. For this initiative, the collaboration focused on extending these capabilities to streamline remote case submission and management.
The key innovation was an OCR-based case accessioning workflow.
In this approach, PathPresenter extracts relevant metadata, such as patient identifiers and case details, directly from the labels present on the scanned slide images. This information is automatically interpreted and structured into a digital case record, eliminating the need for manual data entry.
This automated workflow has several immediate advantages:
No reliance on a shared LIS or complex integrations: Partner institutions do not need to use the same system as OSUCCC-James
Reduced administrative burden: Staff are not required to manually enter patient and case details
Improved accuracy: Automated data capture reduces transcription errors
Faster case submission: Cases can be created and transmitted in minutes
Once a case is submitted, the digital case is automatically ingested into OSUCCC-James’ central EPIC LIS and assigned to the requested subspecialist pathologist or an appropriate subspecialist based on case requirements. The pathologist reviews the case using PathPresenter’s IMS and FDA-cleared viewer, and signs out the diagnosis, with the report automatically transmitted back to the LIS and the referring hospital, closing the loop.
This end-to-end workflow transforms what was once a multi-day or multi-week process into one that can be completed within hours.
With this program’s implementation, announced by OSUCCC in April, remote centers like Wooster Community Hospital can now submit cases without needing an LIS at all, relying instead on the automated workflow built into the platform to handle the flow without increasing the administrative burden.
Results and Impact: Faster Diagnoses, Broader Access, Better Care
The implementation of PathPresenter’s digital consultation workflow brings measurable impact across the James Cancer Network.
Dramatically Reduced Turnaround Times Consultation timelines can reduce from days or weeks to just hours. This acceleration enables faster clinical decision-making, which is especially critical in oncology where timely intervention can significantly affect outcomes.
Elimination of Physical Logistics The need to transport glass slides has been effectively removed. This not only reduces delays but also minimizes the risk of damage or loss during transit.
Streamlined Workflows and Reduced Administrative Burden Automated case accessioning eliminates redundant data entry, freeing up staff to focus on higher-value clinical tasks. It also improves consistency and data quality.
Interoperability Across Diverse Systems The solution accommodates a wide range of partner institutions, regardless of their existing IT infrastructure. This flexibility is essential for scaling across a regional network.
Enhanced Pathologist Experience Consulting pathologists can review cases within a familiar, integrated environment. The workflow aligns with existing diagnostic practices, ensuring efficiency without disruption.
Strong Security and Compliance The platform meets stringent requirements for privacy protection, regulatory compliance, and data security, critical factors in handling sensitive patient information.
Scalable Foundation for Network Growth With a proven digital infrastructure in place, OSUCCC-James can continue expanding its network, bringing advanced diagnostic capabilities to more communities.
Enabling the Future of Connected Cancer Care
Beyond operational improvements, the broader impact of this initiative lies in its ability to connect patients to more advanced care pathways.
By making subspecialty expertise readily accessible, the program ensures that patients in regional hospitals receive the same level of diagnostic insight as those treated at a major academic center. This can influence not only diagnosis but also eligibility for targeted therapies and clinical trials.
Importantly, it also strengthens collaboration between institutions. Community hospitals become more deeply integrated into the academic center’s ecosystem, benefiting from shared knowledge, resources, and innovation.
As OSUCCC-James continues to expand the James Cancer Network, digital pathology consultations serve as a cornerstone of its strategy, demonstrating how technology can bridge gaps in access and elevate the standard of care across an entire region.
Conclusion
The partnership between OSUCCC-James and PathPresenter illustrates how thoughtful application of digital pathology can overcome longstanding barriers in healthcare delivery. By focusing on automation, interoperability, and user-centered design, the solution transforms complex workflows into seamless, scalable processes.
The result is not just faster consultations, but a more equitable healthcare system, one where geography no longer limits access to expert cancer diagnostics.
More information
Interested in learning more about how solutions like this can help solve your own challenges? Contact us at pathpresenter.com/contact
The Pathologist as the Architect of Clinical Intelligence
Last week, I was invited to serve as a judge for a “Shark Tank” style competition at the University of Pennsylvania. At the conclusion of several spectacular presentations, all of which featured the innovative use of AI, a resident in the audience asked the million-dollar question: “Do I have a future as a pathologist?”
It is a question often framed with uncertainty—will AI replace us or commoditize our work? My answer is that the role of the pathologist is not diminishing but quietly expanding. We are moving from a diagnostic service to becoming the most valuable data engine in medicine. For decades, pathology has been the “ground truth” where cells and microenvironments are observed directly. Yet, this richness has historically been a computational dead end because we digitized images without digitizing meaning.
That transition is occurring now through three converging technological shifts that turn the image management system into an active collaborator. First, Foundation Models now read whole-slide images directly to extract critical features like TIL density and tumor burden. Second, Structured Narrative tools utilizing large language models convert our narrative prose into governed data with accuracy exceeding manual abstraction. Finally, Agentic Frameworks allow for cohort definition in plain language, delivering traceable results in minutes and removing traditional operational bottlenecks. Together, these technologies ensure that everything visible on a slide becomes computable.
The true power of these technologies lies in their invisibility; intelligence is embedded directly into the Image Management System (IMS) rather than being siloed in a dashboard. While the pathologist focuses on the diagnosis, background agents handle the operational heavy lifting. Specimen Logistics agents follow specimens through the lab to identify delays or staining inconsistencies before they breach turnaround times. Predictive Metadata Enrichment anticipates clinical pathways by identifying likely immunostains or molecular tests, suggesting CPT codes, and pre-filling reports. By surfacing relevant literature and potentially providing “virtual stains” that eliminate 48-hour waits, the platform ensures expertise is supported by a comprehensive data layer without interrupting workflow. Even the complex ontologies and data standards that once took years of committee work to codify can now be harmonized on the fly. By utilizing supervisory agents that map local findings to global standards in the background, we ensure that a diagnosis rendered in one institution carries the same precise, computable meaning in another. This background alignment allows the pathologist to focus entirely on the tissue while the system ensures the resulting data is instantly interoperable and research-ready.
This evolution reframes our impact from “throughput” to “leverage”. Each diagnosis is no longer a discrete event; it becomes a computable data point in a multimodal dataset. Because we see the disease itself in its structural context, we are uniquely positioned to lead this transformation. The future of healthcare will be built around the data that pathologists already hold. Our opportunity is to remain operationally central by shaping how these systems are designed and how meaning is preserved. Pathology is no longer just a service; it is the most valuable data asset in medicine, and those who build this capability first will hold the keys to the future of personalized care.
The future of pathology has never been brighter; we are moving from the basement of the hospital to the very epicenter of precision medicine, where our insights will drive every major clinical decision in the digital age.
About the Author
Dr. Rajendra Singh is a Professor of Pathology at the University of Pennsylvania and co-founder of PathPresenter. He serves as a member of the Digital and Computational Pathology Committee of the CAP, Editorial Board of the WHO for Classification of tumors, 5th Edition and the Board of Digital Pathology Association.
Success Story: Clinical Validation of AI in Dermatopathology with Primaa and PathPresenter
PathPresenter platform enables a smooth study; Primaa CLEO model brings measurable improvements in efficiency and diagnostic agreement
Artificial intelligence is rapidly transforming the field of pathology, but demonstrating its real-world clinical value requires carefully designed validation studies. When AI developer Primaa set out to evaluate the impact of its CLEO dermatopathology model through a clinical study, their team needed a robust platform capable of delivering whole slide images, enabling structured evaluation, and capturing detailed performance metrics from participating pathologists.
PathPresenter was proud to partner with Primaa to support this initiative, providing the secure digital infrastructure that made smooth operation of the study possible.
Evaluating the Impact of AI on Diagnostic Performance
In late 2025, Primaa began a clinical validation study to measure how its CLEO AI model could support pathologists in real-world dermatopathology diagnostic situations. The study compared diagnostic performance when pathologists reviewed cases with and without access to CLEO’s AI-powered assistance.
The goal was twofold: measure improvements in efficiency and assess gains in diagnostic effectiveness.
On the efficiency side, the study evaluated time savings per case and examined how CLEO affected specific diagnostic tasks, including:
Classification of lesions
Mitotic counting
Lesion measurement
For effectiveness, the study focused on key diagnostic quality metrics, including:
Interobserver agreement among pathologists
Sensitivity in detecting mitoses
Accuracy in classifying lesions
Cases included a range of dermatopathology diagnoses such as melanoma, nevus, squamous cell carcinoma (SCC), basal cell carcinoma (BCC), and other benign lesions, providing a realistic clinical mix for evaluation.
To conduct the study successfully, Primaa needed a platform that could provide participating pathologists with seamless access to cases, whole slide images (WSIs), and the CLEO AI model while also capturing detailed interaction data and performance metrics.
A Purpose-Built Platform enabling Clinical Studies
PathPresenter’s Image Management System (IMS) Clinical Module served as the platform for the study, with Primaa’s CLEO model seamlessly integrated into the image viewer. Given both companies’ commitment to interoperability, the integration was quickly and easily done.
Using PathPresenter, participating pathologists were able to access all study materials, including digital slides and associated case information, through a single, intuitive interface that gave easy access to the CLEO model. The platform delivered a consistent experience for each participant, ensuring standardized workflows across the study.
Equally important, the PathPresenter environment provided the security and compliance required for clinical research, meeting strict privacy and data auditability and traceability standards. This allowed Primaa to confidently share study data with participating experts while maintaining full regulatory compliance.
Beyond simple access to slides, PathPresenter enabled the structured collection of study data. The platform captured detailed metrics, including time spent per case and time required for specific diagnostic tasks, allowing the Primaa team to precisely quantify the impact of AI assistance on workflow efficiency.
Because the platform centralized all case review activity, it also made it easier for study organizers to monitor participation, ensure consistency across reviewers, and aggregate results for analysis.
Measurable Improvements in Efficiency and Diagnostic Agreement
The full results of the study are forthcoming, but in the early results from phase 1, the study has already demonstrated positive value for AI-assisted pathology workflows.
Primaa’s CLEO model enabled faster turnaround times per case, helping pathologists complete reviews more efficiently. The study also showed significant improvements in mitotic counting speed, one of the most time-consuming and tedious tasks in dermatopathology evaluation. Overall CLEO enabled a 25% reduction in analysis time.
In addition to efficiency gains, CLEO enabled a 6% improvement in diagnostic accuracy. Pathologists using the AI model demonstrated:
Increased interobserver agreement when classifying lesions
Higher sensitivity in detecting mitoses
Improved accuracy in lesion classification
These findings highlight the potential for AI tools like CLEO to not only accelerate pathology workflows but also enhance diagnostic reliability across practitioners.
Enabling the Future of AI Validation in Pathology
As AI continues to enter clinical practice, rigorous validation studies will play a crucial role in demonstrating safety, effectiveness, and real-world value. Platforms that enable secure collaboration, standardized workflows, and precise measurement are essential to making these studies possible.
PathPresenter is proud to support and partner with organizations like Primaa that are pushing the field forward through transparent, quantitative research.
The full results of Primaa’s CLEO validation study will be available when all phases are complete. More information about the study and Primaa’s work in AI-driven pathology, including skin and breast models, can also be found at primaalab.com.
See it in action at USCAP 2026
Primaa and PathPresenter will demonstrate their solutions at USCAP 2026 in San Antonio, March 23-25. Visit PathPresenter at booth #349 or Primaa at booth #836 for live demonstrations of the full suite of modules and integrations and more on the study results. Interested in a personal demo? Reach out to us at www.pathpresenter.com/contact
PathPresenter Invites Pathologists to Expect More from their IMS with Image Biorepository Management Module at USCAP 2026
Updated module delivers powerful new data integration, multimodal imaging, governance, and AI capabilities for organizations across the biomedical research ecosystem
Montville, NJ — March 11, 2026 — PathPresenter today announced it will debut its enhanced Image Biorepository Management module at the USCAP 2026 Annual Meeting (March 23–25) in San Antonio, inviting pathologists to expect more from their IMS and get more with PathPresenter. The updated module is a key component of PathPresenter’s comprehensive image management system, which supports digital pathology across primary diagnosis, clinical consultations, biomedical research, and education.
Academic centers, AI developers, pharmaceutical companies, CROs, and tissue banks generate vast volumes of data, including whole slide images (WSIs), annotations, and detailed slide-level metadata. Yet without strong organization and governance, these valuable assets are often siloed in disconnected systems, limiting collaboration and downstream research value.
PathPresenter’s enhanced Image Biorepository Management module provides a centralized, secure environment for organizing, searching, analyzing, and sharing pathology datasets, giving institutions greater control over their digital assets. Developed with input from leading research institutions, the platform is designed for organizations seeking stronger data governance and visibility. It enables controlled data discovery and sharing while maintaining compliance with approved research protocols, and its HIPAA-compliant infrastructure supports complex research workflows to improve efficiency and accelerate discovery.
Key features include:
Image Data and Metadata Management: Tools to store and organize diverse image datasets beyond WSIs within structured research collections. The FDA 510(k)-cleared clinical viewer supports multiplex immunofluorescence, DICOM, electron microscopy, and other modalities.
Data Governance: Controls to manage dataset access, support institutional governance requirements, and enable read-only discovery of curated datasets with request-based access for research or educational use.
EMR Data Integration and Abstraction: Secure connectivity to electronic medical record (EMR) systems to extract and structure clinical data, such as diagnoses, molecular results, and longitudinal patient history, so that it can be linked with imaging datasets and made usable for research and cohort discovery.
AI Application Integration: Support for running WSI-based AI applications directly within the research environment to enable analysis and discovery.
“Throughout my career in academia, pharma, and AI development, I saw how difficult it was to access high-quality pathology images. Data was shipped on hard drives, images had to be manually linked to metadata, slides were physically sent between sites, and there was often little visibility into image inventories. In many cases, teams even purchased large numbers of specimens just to find the few they needed while many others sat unused in freezers. The process wasted enormous time, effort, and investment for everyone involved,” said Dr. Cory Batenchuk, PathPresenter co-founder and SVP of Operations. “We built this module for organizations facing these challenges every day, making governed image access simple, scalable, and accessible. Feedback from our pilot program shows researchers love what it makes possible.”
Expect more from your IMS. Get more with Pathpresenter.
PathPresenter invites pathologists to get more of what they need. Get more power for primary diagnosis with our FDA-cleared and CE-IVDR-certified clinical viewer. Get more interoperability with leading LIS systems. Get more integration with the best AI models. Get more ROI with our consult module. PathPresenter’s comprehensive platform supports clinical practice, research, and education through modules that function independently or seamlessly together, helping institutions maximize their digital pathology investments.
See us at USCAP
Attendees will be welcomed at booth #349 during USCAP 2026 for live demonstrations of the full suite of modules and integrations. Interested in a personal demo? Reach out to us at www.pathpresenter.com/contact.
About PathPresenter
PathPresenter is an enterprise-grade digital pathology platform designed by pathologists for pathologists. It provides a vendor-neutral image management and workflow solution supporting clinical diagnosis, remote consultation, education, and research. Its Clinical Viewer has earned FDA 510(k) clearance and CE-IVDR certification for primary diagnosis in approved configurations. By enabling integration with best-in-class AI tools and fostering interoperability, PathPresenter helps laboratories adopt advanced digital pathology workflows confidently and efficiently. Learn more at www.pathpresenter.com.
The next generations of pathologists are demanding digital education now
As medicine becomes more precise and data-driven, pathology is undergoing a transformative shift toward digital technology. This transition promises to revolutionize how pathologists work, improving accuracy, efficiency, and collaboration, while ultimately enhancing patient outcomes. Nowhere is this transformation happening faster or more profoundly than in pathology education. And increasingly, it is pathology trainees—residents and fellows—who are driving the demand.
A recent example from the Yale School of Medicine puts this shift into clear focus. When distinguished Yale professor and internationally recognized genitourinary pathologist Dr. Peter A. Humphrey, MD, PhD, retired in 2025, he left behind a spectacular and unique collection of pathology slides that he had used to educate generations of trainees about rare and complex cases. Over 40 years of practice, consultation, and teaching, Dr. Humphrey amassed not just slides, but insight: annotations, diagnostic pearls, and pattern-recognition wisdom refined over decades.
Through a project led by Dr. Roxanne Wadia, these slides are now being digitized (using the PathPresenter platform), along with Dr. Humphrey’s annotations, so that his experience can continue to guide new generations of residents and fellows at Yale and beyond.
“Dr. Humphrey’s slide collection represents a lifetime of mastery, an extraordinary legacy that deserves to be more than preserved,” said Dr. Raj Singh, professor of pathology and PathPresenter co-founder. “It deserves to be shared.”
This kind of knowledge sharing is admirable, but for today’s trainees, that sharing is not just inspiring, it is becoming expected and even essential. At Yale and many other institutions, digital platforms are no longer viewed as optional enhancements. They are becoming core infrastructure for training pathologists in a world that is already digital.
The Advantages of Digital for Pathology Education
When it comes to delivering pathology education, a digital platform such as PathPresenter offers compelling benefits. But viewed through the lens of trainees, these advantages become even clearer: digital tools directly address the daily challenges residents and fellows face.
Eliminating Physical Constraints
Residents learn pathology by seeing cases—lots of them. Yet traditional training models often limit access. Glass slides are tied to specific microscopes, labs, and physical locations. Rare cases may be archived and difficult to retrieve. Multi-headed scopes allow small-group teaching, but only for those physically present.
Digital platforms eliminate these constraints. With whole-slide imaging, specimens can be digitized at high resolution and shared almost instantly with learners anywhere in the world. Instead of crowding around a microscope, trainees can review cases independently, revisit them after sign-out, and study them before board exams. They can zoom, pan, and explore at their own pace, without worrying that the slide must be returned to circulation.
For busy residents balancing clinical service, conferences, research, and exam preparation, this flexibility is transformative. Learning is no longer limited to “when the slide is available.” It becomes on-demand and continuous.
Pathology depends heavily on visual pattern recognition. Even the most detailed written description of a cellular structure cannot match the power of an image. When trainees and attendings view the exact same digital slide simultaneously, discussions are more precise. Feedback is clearer. Diagnostic reasoning becomes more transparent.
Digital images also preserve rare and valuable cases that trainees might otherwise never encounter. Instead of being stored in a single institutional archive, these collections can be shared globally. For residents preparing for subspecialty fellowships or boards, exposure to rare entities is invaluable.
This is precisely what Yale envisions for Dr. Humphrey’s collection: preserving and sharing his legacy so it can continue to guide and challenge future pathologists. Open access to world-class pathology knowledge is not just a philosophical goal, it directly supports trainee growth and confidence.
Unlocking Interactive Learning
Today’s trainees do not want to passively observe, they want to interact.
Digital platforms enable educators to annotate directly on slide images, highlight key diagnostic features, add measurements, and create guided tours through complex cases. For trainees, these annotations become enduring teaching points that can be revisited long after the live session ends.
Learners can also engage actively, leaving comments, asking questions, and even participating in real-time chats. Instead of fleeting conversations at a microscope, discussions become documented and searchable. Slide metadata, clinical history, and diagnostic commentary can travel with the image, ensuring that context is never lost.
For residents preparing for tumor boards, unknown conferences, or board examinations, this depth of context is critical. It allows them to connect morphology with clinical implications, immunohistochemistry, molecular findings, and outcomes.
Digital platforms also support structured curriculum delivery. Organized modules, case libraries, integrated quizzes, and assessments provide clarity in a training environment that can otherwise feel overwhelming. Immediate feedback helps trainees identify knowledge gaps early. Progress dashboards and certification tracking bring transparency to competency development.
In an era where pathology training varies across institutions, digital platforms help standardize access to high-quality content. For trainees, that consistency means greater confidence, regardless of where they train.
Enabling Global and Remote Learning
Trainees today are part of a global medical community, and digital pathology platforms break down geographic barriers, allowing residents and fellows to learn from experts far beyond their home institutions. A trainee in a resource-limited setting can now access the same high-quality cases and instruction as a learner at a major academic center.
Virtual tumor boards, international conferences, and cross-border case discussions are no longer rare events, they are increasingly routine. For fellows pursuing subspecialty expertise, exposure to diverse case material and global perspectives strengthens both diagnostic skill and professional networks.
For many trainees, remote learning is not a compromise; it is an opportunity, and perhaps even a necessity.
Integrating Artificial Intelligence into Training
The pathologists of tomorrow will practice in environments shaped by artificial intelligence. AI models are already being integrated into clinical workflows and research applications, from image analysis to diagnostic support.
Trainees recognize this shift. They want to understand not only how to interpret slides, but how to evaluate and leverage AI tools responsibly.
Comprehensive digital platforms provide a natural environment for this integration. In a digital workspace, residents can explore AI-assisted analyses, compare algorithmic outputs with their own interpretations, and develop the critical thinking skills necessary to use these tools wisely.
Exposure during training ensures that future pathologists are fluent in both traditional morphology and digital augmentation. Digital literacy is becoming as fundamental as microscopic technique.
Meeting Trainee Expectations
Today’s residents and fellows are digital natives. They expect intuitive interfaces, instant access to resources, and collaborative tools that resemble the platforms they use in other aspects of their lives.
They also understand that their future employers (academic centers, hospitals, laboratories) are moving toward digital pathology workflows. They want their training environment to reflect that reality.
Institutions that embrace digital platforms signal to trainees that they are forward-looking and invested in preparing them for modern practice. Those that do not risk falling behind, not only technologically, but competitively in recruiting top talent.
The Digital Future Is Now
The shift toward digital pathology education is already underway, and trainees are at its center. The benefits are clear: expanded access, interactive learning, global collaboration, standardized curricula, AI integration, and preparation for real-world practice.
As the practice of pathology becomes increasingly digital, education must mirror that evolution. For residents and fellows, digital platforms are not optional enhancements. They are essential tools for mastering the discipline.
Let Us Help You on Your Path
PathPresenter was created specifically to unlock the opportunities that a digital education platform offers. With tens of thousands of users, our public platform is the world’s largest pathology education community. For institutions, our enterprise education module enables organizations to manage, deliver, and generate measurable ROI on digital pathology education, while integrating seamlessly with clinical practice and research.
Whether you are modernizing your residency curriculum, digitizing legacy collections, hosting global conferences, or building a private learning portal for trainees, PathPresenter has a powerful platform to help you. We would be delighted to discuss your pathology education goals.
The next generation of pathologists is ready for a digital future. Let us help you build it.
Why a Vendor-Agnostic IMS Is Key to a Future-Proof AI Strategy
by Patrick Myles, MBA CEO, PathPresenter
As AI adoption accelerates in digital pathology, many institutions are facing a strategic decision that will shape their technology stack for years to come: how tightly should AI be coupled to the core imaging and workflow platform?
At PathPresenter, we’ve taken a very deliberate position. On the AI side, we are intentionally AI-agnostic at the IMS and workflow level. That decision is rooted not in theory, but in hard-earned lessons from the field.
The Hidden Cost of Closed AI Ecosystems
Over the years, we’ve seen multiple institutions make large investments in closed scanning and workflow ecosystems, often driven by early regulatory approvals or the promise of an “end-to-end” solution. In the short term, those systems worked. But over time, they frequently became bottlenecks.
When institutions later wanted to onboard additional scanners, integrate third-party tools, or adopt stronger algorithms from competing vendors, those closed platforms made change slow, expensive, or in some cases impossible. The result was delayed deployments, integration failures, and ultimately costly replacement projects that disrupted operations far more than anyone anticipated.
That model simply doesn’t hold up in today’s AI landscape.
AI Is Changing Too Quickly for Locked-In Platforms
AI is moving at a pace we’ve never seen before. Many algorithms deployed in production today are CNN-based, while the next wave of capability is clearly shifting toward foundation-model approaches. As performance improves and new vendors emerge, the “best” solution will continue to change.
In that environment, locking the core IMS and workflow layer to a specific AI vendor is a strategic risk. Our view is simple: the IMS should remain independent of the AI layer.
A Future-Proof Strategy that Keeps the Platform Stable While AI Evolves
To make that separation practical, we’ve invested heavily in building an AI middleware layer designed to be future-proof. This middleware can ingest, normalize, and orchestrate the clinical and operational data required to deploy AI at scale, including integrations built on HL7, FHIR, and DICOMweb. By abstracting these complexities away from the core platform, institutions can adopt new AI models and workflows over time without needing to rebuild integrations or re-platform each time the ecosystem evolves.
Just as importantly, this approach is informed by real-world experience. We’ve worked with a wide range of institutions and organizations and have seen multiple generations of digital pathology and AI vendors come and go. Some early companies were highly innovative, but struggled to scale or keep pace with market shifts.
Those experiences have consistently reinforced the same conclusion: workflow platforms must remain stable, while the AI layer must remain flexible.
In an AI landscape defined by constant change, future-proofing isn’t about predicting which algorithm will win. It’s about designing systems that can evolve, without disruption, as the technology does.
About the Author
Patrick Myles is CEO of PathPresenter. Previously, he was CEO of Huron Digital Pathology, and Vice President of Business Development for Teledyne DALSA. He served as a board member of the Digital Pathology Association.
Remote second opinions can be a gateway to proving the value of digital pathology
Digital pathology has reached an important inflection point. Adoption is rising, evidence of clinical and operational value is strong, and digitization is widely accepted as the future of pathology. Yet as Imogen Fitt of Signify Research pointed out in her recent analysis of the market, near-term adoption remains uneven. For many institutions, digital pathology still feels like something to plan for tomorrow rather than act on today.
The reasons are well understood. High upfront costs, complex and lengthy implementations, interoperability challenges and heavy administrative overhead all combine to slow decision-making. Even organisations that are philosophically aligned with digital pathology often struggle to justify investment when budgets are under pressure from other enterprise-scale initiatives such as LIS replacements, oncology platforms or radiology IT refreshes. The result is a persistent gap between recognised long-term value and near-term return on investment.
What many organizations are seeking is not another abstract promise about future AI or biomarker discovery, but a way to realise tangible benefits quickly, in a form that aligns with their specific clinical and operational realities. This is where a more targeted, use-case-driven approach to digital pathology can make a meaningful difference.
Thinking outside the building
For institutions with significant subspecialty expertise, remote second opinion services represent one of the most compelling and immediately actionable applications of digital pathology. They address real clinical needs today: managing rising case complexity, improving access to scarce expertise (just locally but even globally), supporting workforce sustainability and generating new, scalable revenue streams. PathPresenter’s ConsultConnect was designed specifically to unlock this opportunity while removing many of the barriers that slow broader digital pathology adoption.
ConsultConnect is a secure, “zero-footprint” cloud-based platform built to enable remote pathology consultation at scale, allowing consulting institutions with specialty expertise to take referral cases from remote organizations with ease. Rather than requiring a full digital pathology rollout, it allows organisations to start with a focused, high-value workflow that delivers rapid impact. This fundamentally changes the cost–value equation.
First, ConsultConnect eliminates the issue of high upfront costs. There is no capital expenditure on IT infrastructure and partners such as Grundium can provide pathways to cost-efficient slide scanners optimized for rapid deployment. Instead of large initial outlay and a long procurement cycle, the ConsultConnect model is based on a minimal annual commitment with simple, transparent “per-consult” pricing. This makes financial planning easier and aligns cost directly with value generated.
Second, it removes the burden of complex implementations. Traditional DP projects can take months or years to move from approval to production, often involving shared IT infrastructure, local software installation and extensive validation. ConsultConnect deploys in days, not months. Because it is “zero-footprint” cloud-native and requires no shared infrastructure between organisations, it avoids many of the technical bottlenecks that stall progress.
Interoperability is another major friction point in digital pathology adoption, particularly as laboratories seek to simplify fragmented IT environments. ConsultConnect removes this barrier by accepting images from virtually any whole slide scanner or file format. Institutions do not need to standardise on a single vendor or invest in expensive integration work to participate, making it an ideal solution in heterogeneous or transitional environments.
Administrative hurdles will always vary by organization, but ConsultConnect significantly reduces their impact by minimising IT, funding, and operational complexity. Importantly, it also offers something many DP initiatives lack: a fast, credible path to revenue generation. By enabling institutions to scale remote second opinion services securely and efficiently, the platform turns digital pathology from a cost centre into a potential revenue driver.
The result is a low-risk, high-impact entry point into digital pathology. Institutions can support referring pathologists, extend the reach of their subspecialty expertise, and deliver measurable ROI in the near term, without waiting for large-scale transformation programs to clear internal hurdles.
From “Why Now?” to “Yes, Now”
In a market where “why now?” remains one of the hardest questions to answer, ConsultConnect provides a practical response. It demonstrates that digital pathology does not have to mean extra work, excessive risk or deferred value. Instead, it can be a rational, incremental step that delivers tangible benefits today while laying the foundation for broader digital adoption tomorrow.
Does your institution have expertise to share, ambitions to scale, and aspirations for digital transformation? ConsultConnect could be right for you. We’d love to discuss your needs.
Digital Pathology Basics: What is Digital Pathology
From Glass Slides to Intelligent Diagnostics
Pathology sits quietly at the center of modern medicine. Although patients may never meet a pathologist, roughly 70% of clinical decisions are influenced by pathology reports, earning pathologists the nickname “the doctor’s doctor.” For more than a century, however, the core pathology workflow has remained largely unchanged: tissue is mounted on a glass slide, examined under a microscope, diagnosed by a specialist, and then physically stored for future reference.
Digital pathology represents a fundamental shift beyond this analog process toward a data-driven, connected, and computational future.
What Is Digital Pathology?
Digital pathology refers to the acquisition, management, sharing, and analysis of pathology information in a digital environment. At its core, this involves converting traditional glass slides into high-resolution digital images using specialized scanners, a process known as whole slide imaging (WSI). Once digitized, these images can be viewed, shared, analyzed, and archived electronically rather than handled and stored physically.
But digital pathology is more than simply scanning slides. Digital pathology and informatics combine imaging, laboratory data, information systems, and advanced analytics including artificial intelligence (AI) to support diagnosis, research, and patient care.
The Traditional Pathology Workflow…and Its Limits
The conventional workflow has been largely unchanged for over 100 years: a tissue sample is prepared on a glass slide, reviewed by a pathologist under a microscope, diagnosed, and then placed into long-term storage. The final pathology report becomes part of the patient’s medical records, which are increasingly migrating to electronic health record (EHR) systems.
While this process has delivered reliable diagnoses for decades, it comes with limitations:
Physical slides must be manually transported, stored, and retrieved
Sharing cases for consultation or second opinions is slow and logistically complex
Access is limited to the location of the microscope and slides
Slide information remains firmly analog. Without images, slide information is inaccessible to computational analysis
These constraints have become more apparent as healthcare systems seek faster workflows, remote collaboration, and data-driven insights.
The Digital Pathology Workflow
A digital pathology workflow begins with slides like the traditional process, but quickly adds key digital enhancements:
Tissue Preparation – Samples are still prepared on glass slides using standard histology techniques.
Slide Scanning – Slides are scanned using high-resolution scanners, producing extremely large image files. Scanner capabilities vary widely in throughput, resolution, and file format, creating opportunities (and challenges) for standardization and quality control.
Image Upload and Management – Digital slides are stored and organized within image management systems (IMS), which must handle massive data volumes and integrate with laboratory information systems (LIS), picture archiving systems (PACS), and EHRs
Diagnosis – Pathologists review images through digital viewers, usually part of an IMS and ideally directly integrated with the organization’s LIS. The digital format enables remote access, rapid consultation, and the use of AI-based decision support tools.
Reporting – Diagnostic reports flow back into the LIS and onward to treating clinicians, with opportunities for automation of routine administrative tasks
This end-to-end digital flow reduces friction, increases accessibility, and creates a foundation for computational analysis.
The Benefits of Digital Pathology
The benefits of digital pathology extend beyond convenience. Key advantages include:
Operational efficiency – Digital slides eliminate much of the manual handling, transport, and physical storage required for glass slides.
Speed and accessibility – Digital data moves faster than physical specimens, enabling quicker diagnoses and easier sharing across locations.
Remote work and collaboration – Pathologists can review cases from anywhere, supporting telepathology, virtual tumor boards, and global second opinions.
Automation and integration – Digital workflows can connect pathology data with other clinical systems, reducing administrative burden and errors.
Advanced analytics – Digitized images unlock AI-driven image analysis, supporting tasks such as quantification, pattern recognition, and quality control
Together, these capabilities help address growing diagnostic workloads and workforce shortages while improving consistency and scalability.
Digital Pathology as Big Data
Once pathology becomes digital, it becomes data, and a lot of it. Whole slide images are each often multiple gigabytes in size and are among the largest data objects in healthcare. Indeed, file storage can become a significant issue and one of the largest cost drivers in digital pathology. When combined with other data types, WSIs form part of a rapidly expanding biomedical data ecosystem.
Done properly, digital pathology data can be integrated with:
Genomics and molecular data
Radiology images (radiomics)
Clinical history and treatment outcomes
Institutional and population-level datasets
This convergence enables new fields such as pathomics, where computational analysis extracts quantitative features from pathology images at a scale impossible for human observers alone.
These datasets power research, clinical trials, drug discovery, and AI model development across academia, healthcare systems, and the life sciences industry.
The Hidden Complexity of Going Digital
Despite its promise, digital pathology is not a simple “plug-and-play” transformation. Purchasing scanners and viewing software is only the visible tip of the iceberg. Successful implementation requires alignment across technology, people, and processes.
Key challenges include:
Managing massive image storage and data transfer
Integrating multiple systems and vendors
Ensuring regulatory compliance and validation
Training pathologists and laboratory staff
Adapting workflows that have been stable for decades
Hidden complexities often emerge mid-implementation, making domain expertise and flexible system design essential, and highlighting the need for organizations to carefully choose a workflow partner with deep domain knowledge, flexibility and expertise.
Pathology: at the Center of Personalized Medicine
At its full potential, digital pathology becomes a central hub for personalized medicine. By connecting diagnostic images with molecular profiles, clinical history, and treatment response, healthcare systems can move toward more precise diagnoses, better risk stratification, and tailored therapies.
Digitization breaks down data silos and creates new opportunities across clinical care, research, and education, positioning pathology not just as a diagnostic service, but as a foundational data science discipline in modern healthcare.
More Information
Are you or your organization considering a digital pathology project? We’d love to discuss your unique needs and help you explore the best solution.
Behind the Scenes of a Successful FDA 510(k): PathPresenter’s Clinical Viewer Journey
by Brian Matcheski Regulatory Manager, PathPresenter
FDA 510(k) clearance is often described as a milestone in digital pathology. What’s discussed less is how you actually get there, especially for software-only image viewers, where regulatory expectations differ meaningfully from scanners and other hardware-based systems.
With the recent FDA 510(k) clearance of the PathPresenter Clinical Viewer, we wanted to share some perspective on our journey: what mattered most, what surprised us, and why a disciplined approach to the process ultimately pays dividends. This isn’t a detailed how-to guide, and there are no shortcut hacks to share (with the possible exception of “get good advice from a qualified regulatory expert with experience in digital pathology”). But for those involved in navigating FDA clearance for digital pathology software, these insights from our journey may prove interesting.
Why FDA Clearance Matters in Digital Pathology
As digital workflows in pathology move from research into routine clinical use, regulatory oversight becomes essential to building trust and enabling adoption. FDA regulation of digital pathology software ensures that clinical tools meet standards for safety, effectiveness, and reliability.
The FDA has several pathways for market clearances, but to date, digital pathology devices have concentrated on just two: de novo and 510(k). The de novo (Latin for “new”) pathway is used for new devices with no existing precedent (or predicate). The 510(k) pathway applies when a new device can demonstrate substantial equivalence to an existing, legally marketed predicate. Clearly, the 510(k) pathway is only available when a predicate already exists; it clears a new component to do an equivalent job in an existing system. Not surprisingly, de novo clearances typically involve greater regulatory uncertainty, broader risk justification, and longer timelines than 510(k).
Neither clearance pathway represents FDA “approval,” nor do they validate clinical outcomes, but clearance is a critical prerequisite for deploying software in regulated diagnostic environments.
For pathologists and labs, FDA clearance provides confidence that a viewer can be used in primary diagnostic workflows. For healthcare systems and enterprise customers, it reduces risk and enables broader clinical integration. For PathPresenter customers, our 510(k) clearance unlocks the ability to deploy our Clinical Viewer in regulated clinical settings with confidence.
Understanding Classification, Intended Use, and Predicates
One of the earliest and most important steps in the process for PathPresenter was clearly defining intended use. Digital pathology viewers are regulated differently from whole slide imaging (WSI) scanners. While scanners capture the image, viewers render, display, and enable interpretation of that image, and the FDA evaluates them separately.
That distinction drives selection of the appropriate predicate device. Substantial equivalence hinges not only on features, but on intended use, performance characteristics, and risk profile. Getting alignment here early set the foundation for the entire submission.
Planning to Succeed: Following the FDA’s Guidance
One of the best decisions we made was to anchor our submission directly to FDA guidance documents, including:
Technical Performance Assessment of Digital Pathology Whole Slide Imaging (WSI) Devices
Content of Premarket Submissions for Device Software Functions
Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions
These documents do more than list requirements, they provide a window into how FDA reviewers think about risk, safety, and effectiveness. By structuring our submission around this guidance, we weren’t guessing what the FDA wanted to see. We were aligning with how the agency approaches review.
A strong 510(k) submission is not about volume. It’s about completeness, traceability, and clarity.
Working with FDA Reviewers
Going into the review, we were cautious. In mid-2025, widely reported austerity measures affecting HHS and the FDA raised concerns across the industry about review timelines and resource constraints.
In our experience, those concerns did not materialize. The FDA’s feedback throughout the review was timely, thoughtful, and constructive. Importantly, our submission was reviewed and cleared within the FDA’s stated 90-day service level.
That experience reinforced our confidence in both the process and the people behind it. Even in a challenging operating environment, the review team remained focused on scientific rigor, patient safety, and predictable execution.
Investing Early Where It Mattered Most: Pixel-Wise Image Comparison
For software-only digital pathology viewers, one of the most scrutinized aspects of a 510(k) submission is pixel-wise image comparison to the predicate viewer. This is an area where other OEMs have historically faced delays.
For a clinical viewer, the primary safety risk is not image acquisition but image presentation. Even small rendering differences, such as altered color balance, contrast, or interpolation, could theoretically influence a pathologist’s interpretation. Pixel-wise comparison evaluates whether the same whole slide image (WSI), when rendered by two different viewers, produces image outputs that are effectively the same at the pixel level. The goal is to show that the subject viewer does not introduce image artifacts, distortions, or rendering differences that could impact clinical interpretation.
We anticipated scrutiny in this area and invested significant effort upfront. That meant carefully defining our comparison methodology, validating our approach, and presenting results that were clear, reproducible, and defensible.
That investment paid off. When FDA reviewers conducted their own image evaluations, they were able to quickly confirm that our viewer met performance expectations, without prolonged back-and-forth. It was one of the most valuable early investments we made in the process.
Responding Quickly and Completely to FDA Feedback
Even with a thorough submission, FDA reviewers are trained to identify areas of potential risk or ambiguity (and they should). We treated every FDA comment as an opportunity to strengthen the submission.
We made our responses timely, direct, and supported by data. There are no shortcuts here. That responsiveness helped maintain momentum and avoid unnecessary review cycles, which can otherwise add weeks or months to the process.
Treating Pre-Submission Feedback as a Contract
Part of the submission process includes Pre-Submission (Pre-Sub) meetings with the FDA. These can be very valuable, but only if the feedback is taken seriously. We treated Pre-Sub input as a contract, not a suggestion.
Every item raised during those discussions was addressed explicitly, point by point, in the final submission. If you’re not prepared to incorporate or directly respond to Pre-Sub feedback, it’s fair to ask why you’re having the meeting at all. Alignment early pays off later.
Building Clinical Trust Through Regulatory Excellence
For PathPresenter, FDA 510(k) clearance is not just a regulatory checkbox. It reflects our commitment to building clinical software that pathologists can trust in real-world diagnostic workflows.
We’re proud of the clearance, and equally proud of the disciplined, transparent approach that got us there. As digital pathology continues to evolve, we remain committed to quality, safety, and innovation, grounded in a regulatory process that exists for a reason.
If you’d like to learn more about the PathPresenter Clinical Viewer or see it in action, we invite you to request a demo or reach out to our team.
