Here is January’s Digital Pathology round-up with Imogen Fitt of Signify Research.

FDA Clearances: Paige received FDA 510(k) clearance for its FullFocus™ digital pathology viewer to support additional scanners, the Leica Aperio GT 450 DX and the Hamamatsu NanoZoomer S360MD. Previously cleared for the Philips IntelliSite Pathology Solution, this approval expands Paige’s flexibility in the competitive U.S. market. Similarly, Roche’s VENTANA DP 600 slide scanner gained FDA clearance, boasting a 240-slide capacity, surpassing its predecessor and strengthening Roche’s commercial positioning in the U.S.

FDA Breakthrough Designations: Modella AI’s PathChat DX, a generative AI co-pilot for pathology, received FDA Breakthrough Device Designation. Developed at Mass General Brigham’s Mahmood Lab, PathChat DX builds on previously published research in Nature. However, this designation does not imply FDA clearance or guarantee future approval, with only 10% of such designations historically succeeding. The news underscores the growing role of generative AI in pathology while cautioning against premature assumptions about regulatory success.

Platform Integrations: HistoWiz integrated AI tools from Aiosyn and AIRA Matrix into its PathologyMap platform, targeting research markets where AI adoption is more widespread. Unlike the clinical sector, research environments have seen fewer AI partnerships, but this move signals a trend toward broader AI collaborations in pathology research.

Funding: Deciphex raised $32.3M in Series C funding, led by Molten Ventures and others, to support global expansion, platform development, and new AI models. The company also launched Diagnexia Analytix for drug development pathology. Meanwhile, Bioptimus secured $41M, bringing its total to $76M in under a year. Targeting biotech, medical, and cosmetic industries, Bioptimus plans to launch a new multi-scale, multi-modal foundation model in 2025. While AI advancements continue to generate excitement, commercial success depends on real-world clinical efficacy beyond just superior accuracy.

Imogen Fitt from Signify Research joins us for her predictions for Digital Pathology in 2025.

Trend 1 – Genomics and Digital Pathology Markets Becoming Inextricably Linked

Genomics and digital pathology are converging as distinct yet complementary fields. Increasingly, vendors are developing solutions that bridge the gap between these areas—for example, algorithms are being commercialized to extract genomic biomarkers directly from digital pathology images. Pharmaceutical companies are also collaborating with diagnostic and imaging firms, integrating multi-modal data from whole slide images to create digital companion diagnostics. Furthermore, strategic partnerships and investments (e.g., between molecular diagnostics firms and digital pathology vendors) are helping to merge the two fields. This integration not only enhances personalized medicine by providing a more comprehensive view of patient physiology but also improves laboratory workflows and pre-screening processes. Regions like Northern Europe have already started incorporating genomic data into digital pathology information management systems, demonstrating the growing market demand for such integration.

Trend 2 – Generative AI Boosting Lab Productivity

Generative AI (GenAI) is beginning to reshape lab operations by enhancing productivity and efficiency. Health tech and life sciences companies are actively exploring GenAI applications to automate report generation, consolidate knowledge, and streamline audit and quality control processes. Early initiatives from leading institutions like the Mayo Clinic and companies such as Sanofi illustrate the experimental use of GenAI in laboratory settings, particularly within digital pathology image analysis. Although the commercial impact of GenAI remains in its early stages, its potential to reduce manual tasks and enhance operational workflows is becoming increasingly recognized, indicating that GenAI will soon play a vital role in laboratory productivity improvements.

Trend 3 – Continued Consolidation in the Marketplace

The healthcare technology market is witnessing ongoing consolidation as vendors seek to strengthen their market positions by acquiring complementary businesses. This trend is driven by the need to expand capabilities and streamline product offerings, allowing companies to better meet the evolving demands of the industry. Such acquisitions enable vendors to combine expertise, reduce redundancies, and create more integrated solutions, thereby accelerating innovation and market penetration.

Trend 4 – Digital Pathology’s Clinical Growth Driven by Adjacent Stakeholders and Vendor Types

Although clinical adoption of digital pathology is still emerging, growth is being propelled by stakeholders from adjacent markets. BigTech companies—such as AWS, Microsoft, Google, and Dell—are entering the space, drawn by the revenue potential of whole slide image storage and real-world data management. Pharmaceutical firms are strategizing to secure reimbursement for digital companion diagnostics and exploring deployment models that integrate low-throughput pathology scanners in clinical settings. Additionally, radiology vendors are advocating for standardization efforts (like DICOM and Vendor Neutral Archives), which facilitate the integration of digital pathology systems with broader enterprise imaging platforms. New players in microscopy, laboratory information management systems (LIMS), teleradiology, and image exchange further underscore the expansive growth trajectory of digital pathology.

Overall, while challenges remain, these four trends illustrate a dynamic and transformative future for healthcare, promising significant advancements in patient care, research, and operational efficiency.

Happy Holidays Everyone! Here is the Digital Pathology Round-Up covering events in November with Imogen Fitt of Signify Research.

There will be no December roundup but rather an assessment of the state of the industry and Predictions for 2025 coming in January.

Customer Expansions: Ibex Medical Analytics announced significant expansions with existing customers. Alverno Laboratories, operating in Illinois and Indiana, launched Ibex’s AI-based breast cancer diagnostic platform, building on its earlier adoption of prostate diagnostics. A gastric platform is also in development. Meanwhile, France’s Institut Curie deployed Ibex’s prostate solution, with further expansions planned. These updates highlight the slow but steady adoption of AI in pathology, reinforcing its value despite lengthy validation processes.

Partnerships: OptraSCAN secured $30M in Series B funding, led by Molbio Diagnostics, to accelerate R&D, expand global sales, and enhance AI pathology tools. Partnerships between genomics and digital pathology firms are expected to deepen as AI solutions advance. Lunit Oncology also announced a collaboration with AstraZeneca to develop AI-powered digital pathology tools for assessing non-small cell lung cancer (NSCLC) risks. Using Lunit’s SCOPE Genotype Predictor, this partnership focuses on identifying key mutations, marking Lunit’s first direct deal with a global pharmaceutical company.

Third-Party Integrations: Owkin launched its MSIntuit CRC v2 test for colorectal cancer screening on Proscia’s Concentriq platform and joined the Proscia Ready alliance. The focus now shifts to the implementation of these integrations, whether as pop-ups or embedded tools, and the timeline for deployment. PathAI also announced the integration of tools from Deep Bio, DoMore Diagnostics, Paige, and Visiopharm into its AISight platform. With many IMS platforms adding third-party AI tools, differentiation strategies for vendors in an increasingly crowded market remain a key question

Imogen Fitt from Signify Research joins us for the October Digital Pathology Roundup, which highlights significant developments in digital pathology and related fields, focusing on funding, telepathology, generative AI, and enterprise imaging.

Funding: Mindpeak GmbH secured $15.3 million in Series A funding led by ZEISS Ventures and other notable investors, aiding product development and geographic expansion. Aignostics raised €31.4 million in Series B funding, backed by Athos Partners and Mayo Clinic Ventures, to enhance its platform for translational research and companion diagnostics, following a partnership with Bayer. StratifAI obtained €1.5 million in pre-seed funding from Neulogy Ventures and others to support digital biomarker development for breast cancer and biopharma services.

Telepathology Services: Inify Laboratories announced its expansion into the UK market, focusing on prostate cancer diagnostics, backed by SEK 150 million funding to develop AI for gastrointestinal diagnostics. Originally part of ContextVision AB, Inify pivoted to telepathology using AI. In the US, NorDx adopted PreciPoint's Advanced Digital Pathology Solutions for frozen section diagnostics, emphasizing AI’s role in improving diagnostic turnaround times, a trend supported by investments from major players like Quest Diagnostics.

Generative AI: Proscia introduced "Concentriq Embeddings" and a Developer Toolkit to assist AI development for life sciences. These tools use foundation models like DINOv2 and ConvNext to generate data embeddings from slide images, enabling customized AI workflows and integration.

Enterprise Imaging: Gestalt partnered with Optum to integrate its PathFlow solution into Optum’s Enterprise Imaging Suite. This collaboration, involving Change Healthcare (acquired by Optum), represents a strategic move to advance digital pathology within enterprise healthcare platforms.These advancements underline the growing role of AI and digital solutions in pathology, fostering innovation and collaboration across the industry

September's round-up highlights significant advancements in AI integration, structured reporting, real-world data (RWD), hematology, and funding in the digital pathology space.

Aiforia Technologies partnered with Assistance Publique–Hôpitaux de Paris (AP-HP) to introduce AI-based prostate solutions into clinical use, backed by regional funding from Île-de-France. This initiative aims to study AI's impact in clinical care, with the potential for broader AI implementation across France, as AP-HP plans to expand AI usage across all its pathology departments.

Proscia and Smart Reporting GmbH also joined forces, integrating SmartReports, a structured reporting tool, into Proscia’s Information Management System (IMS). Structured reporting enables the generation of standardized medical reports that facilitate large-scale data comparison and analysis. This tool is crucial for precision medicine and better understanding diseases in RWD studies. Smart Reporting has a strong presence in the radiology field and was highlighted in a comprehensive Imaging IT round-up.

Proscia further introduced an RWD solution on its Concentriq® platform, integrating over 10 million pathology images with clinical and genomic data. This tool offers life sciences organizations access to de-identified patient data for drug development and marks a pivotal step toward making IMS platforms essential links between research and clinical applications.

In hematology, Beckman Coulter Diagnostics and Scopio Labs expanded their partnership, adding the Full-Field Bone Marrow Aspirate (FF-BMA) application to their existing automated hematology solutions. This marks a successful continuation of their collaboration, which began in 2023.

Imogen Fitt from Signify Research joins us to recap the news and events of August.

Paige recently announced several key changes, starting with the appointment of Razik Yousfi as the new CEO. Paige is transitioning its diagnostic AI applications to a standalone solution compatible with other digital pathology platforms. Additionally, the company partnered with Indica Labs, integrating AI models into Indica’s workflow software and focusing on joint commercial efforts in pharma services, preclinical, and translational applications. This shift away from the IMS follows challenges such as market demand for interoperability and slow clinical growth. Paige also announced that its cancer research models, Virchow and PRISM, will be open-source, while advanced versions remain commercially licensed, aiming to boost algorithm usage through its collaboration with Microsoft.

Roche expands its digital pathology open environment by integrating over 20 AI algorithms from eight collaborators to enhance cancer diagnostics and precision medicine.

On the funding front, PreciseDx secured $20 million in a Series B round to commercialize PreciseBreast™ risk assessment. Labcorp and Quest Diagnostics' involvement signals growing interest from major labs in digital pathology (DP). Similarly, SigTuple raised $4 million to expand geographically, focusing on its AI-powered diagnostics product AI100, which received FDA clearance and is expanding into various global markets.

In partnerships, Tribun Health teamed up with Ibex Medical Analytics to integrate Ibex’s AI solutions into its CaloPix platform, offering services in the EU, US, and Canada. Tribun Health’s future AI strategy emphasizes workflow efficiency, strategic collaborations, and interoperability, positioning the company for broader platform integration.

Lastly, Ibex Medical Analytics and PathAI both received IVDR certifications, marking growth milestones for their prostate, breast, and gastric AI solutions. PathAI also announced new developments regarding its IMS platform. These moves highlight a growing momentum in AI-driven diagnostics and partnerships in the healthcare sector.

The July Digital Pathology Round-up with Imogen Fitt of Signify Research is here.

Nucleai and Proscia Partnership: Nucleai and Proscia have partnered to integrate Nucleai's AI Predictive Biomarker algorithms into Proscia's Concentriq platform. This collaboration aligns with the rising interest in digital companion diagnostics (CDx) in clinical trials and diagnostics. The demand for imaging biomarkers is driving rapid investments, especially from pharmaceutical companies, which will influence the digitization of clinical labs. Proscia also updated its digital pathology software, adding DICOM image support and a multi-AI overlay feature, enabling the use of multiple AI tools in the pathology workflow.

UK Pathology and Genomics Collaboration: The National Pathology Imaging Co-operative (NPIC) partnered with CellPath to install two Whole Slide Imaging (WSI) scanners, connecting them to NPIC's national digital pathology system. These scanners will create a digital archive for the 100,000 Genomes Project, a precision medicine initiative. This integration aims to enhance genomics research and develop prognostic algorithms for patient stratification.

Asia-Pacific Developments: 3DHISTECH announced Epredia China as its new distributor. Indica Labs announced new reseller agreements in the Asia-Pacific region, covering the Philippines, Thailand, Vietnam, and Malaysia. Indica Labs plans to pursue IVD registrations, indicating growth opportunities in the APAC region.

Generative AI in Digital Pathology: Scientists from Weill Cornell Medicine and Dana-Farber Cancer Institute developed generative AI tools based on ChatGPT for digital pathology. These tools provide accurate responses to digital pathology queries and help pathologists with PathML, a library for DP image analysis. While impactful in academic circles, concerns about accountability and regulation limit their clinical application.

Philips received 510(k) clearance for its IntelliSite Pathology Solution 5.1, signaling potential competitive dynamics in the US digital pathology market.

Funding Announcements: Scopio Labs raised $42 million in a Series D round led by Fortissimo Capital, aiming to expand globally with a focus on the US market. Clarapath secured $36 million in a Series B-1 round to commercialize its automated microtomy system, SectionStar.

A lot to talk about in June…

ZayaAI introduced a Pathology Laboratory Information System (LIS), addressing integration issues between digital pathology IMS and outdated lab software. The acquisition of Visonex by PreciPoint further indicates market convergence.

PathAI launched two AI products: PathExplore™ Immuno-Oncology Profiling (IOP) and IHC Explore1™, aimed at single-cell image analysis for biomarker discovery and companion diagnostics.

Roche gained FDA 510(k) clearance for its VENTANA DP 200 scanner, marking rapid growth in the US market amidst increased regulation.

Tempus AI went public, providing digital pathology services and patient data access, competing with vendors like Paige and PathAI through advanced algorithms for IHC and H&E staining.

Imogen Fitt is Senior Market Analyst at Signify Research. During her tenure Imogen has completed studies on digital pathology, LabIT and the use of AI in drug development, expanding Signify Research’s diagnostics and life sciences business coverage.

Moving digital pathology to the cloud. We're talking about cloud computing the features and components of the cloud and how it differs from on premise computing. What are the barriers and overlooked considerations in moving your operations to the cloud? What is the truth about storage costs in 2024? Is it still a concern or have the gains been eaten away by the increasingly large amounts of data we continue to generate?

How can cloud computing unlock exciting new applications at a lower cost for organizations? And finally we discuss regulatory considerations for the cloud from the perspective of the FDA EU, GD CP and GCP in developing new drugs and diagnostics.

Alan Lorimer, started his professional journey as an electronics engineer at the BBC. Over his 40-year career, he's founded or led four successful businesses. Notably, he drove an IT hosting company to a successful exit in 2011. He then specialized in IT due diligence for around 60 European companies going through some kind of transaction, sharpening his analytical prowess.

In 2016, Alan pivoted to digital pathology, creating the innovative QDPconnect with OracleBio, leading to the launch of Sciento Technology. Alan's journey from the BBC to cloud computing exemplifies his relentless drive for tech innovation and industry impact.

Today we are discussing how treatment decisions can be personalized through artificial intelligence and digital pathology. Our guest is Andre Esteva of Artera. Atera’s first product is in prostate cancer. We discuss how AI can improve upon the current state of the practice which largely relies on making decisions based on clinical nomograms.

We discuss the concepts prediction and prognosis and how both are incorporated into treatment decisions; what goes into developing and validating AI based algorithms in digital pathology and the importance of validating these algorithms in the appropriate studies specifically randomized clinical trials.

There is one huge advantage of AI based digital pathology tools over genomics and molecular tools. Image based tools can be performed instantaneously rather than waiting days to weeks.

Andre Esteva is a researcher and entrepreneur in medical artificial intelligence. He currently serves as CEO of Artera and was previously Head of Medical AI at Salesforce Research. He has worked at Google Research, Sandia National Labs, GE Healthcare, and has founded four companies.

His research efforts have largely focused on medical AI diagnostics and precision medicine. His publications have made the covers of Nature and Nature Medicine, and have been featured in Cell, The Lancet, NeurIPS, and similar venues. These works have been widely covered by the WSJ, Fortune, BBC, The Economist, and hundreds of other news outlets.