Elizabeth Bourn and I have finished tallying up all of this month's Digital Pathology news, cutting through the noise to provide you a concise summary of the industry's major developments.
But first - are you heading to #HIMSS25? If you're attending and would like to connect, Steve Holloway and the Signify Research Ltd team will be there and happy to chat! ??
If you're particularly interested in the evolution of cloud and enterprise imaging I also encourage you to stop by GE HealthCare's booth (#1725) on Tuesday, March 4th at 12:00 PM for "Unlocking Cloud Potential: Mastering Enterprise Imaging". Steve will be sharing insights on how to leverage cloud technology to optimise enterprise imaging strategies. Don't miss it! ??
With that, here’s February's Digital Pathology news round-up:
- We kicked off the month with Indica Labs announcing it had partnered with Versant Diagnostics to deploy the HALO AP platform across Versant's network of laboratories in the US. The press release highlighted case annotation, collaboration features, usability, and the platform's flexibility in AI integration as key factors in the purchasing decision. This reflects a clear emerging preference among Digital Pathology customers for ergonomic and user-friendly solutions that integrate seamlessly into pathologists' workflows. I've said before, such features will soon become essential for market competitiveness! Versant Diagnostics will be utilising HALO AP as a laboratory-developed test (LDT) for primary diagnosis. This highlights a key point: many Digital Pathology labs have already integrated scanners from various vendors. Indica Labs may have secured FDA approval for use with the NanoZoomer? S360MD slide scanner, there are plenty of other scanners installed and being sold to potential clinical customers in the US. Whilst FDA approval remains a significant milestone for companies, this shows the path to implementation for customers remains far from straightforward today.
- Next Myriad Genetics and Lumea announced a collaboration to integrate Myriad's 'Prolaris prostate cancer' and 'MyRisk hereditary cancer' tests into Lumea's digital pathology platform. The partnership was launched to streamline the ordering process for these tests, enabling pathologists to request them directly through the platform. As I’ve previously noted, in some global markets the pathology IMS is already evolving into a centralised diagnostic cockpit for pathologists, and so it’s encouraging to see US vendors investing in this vision! Across 2025 I expect to see more partnerships between Digital Pathology and Genomics vendors emerge. Send me your guesses for which vendors will be next!
- On a similar note, we saw two other Digital Pathology - Genomics partnerships also appear this month. Imagene and ArteraAI, both Digital Pathology AI start-ups, announced separate collaborations with Tempus AI. Through these partnerships, both vendor's AI-powered assays will be distributed nationwide in the US as part of an integrated molecular testing solution. Two critical aspects emerge from these announcements: firstly, Tempus' digital-pathology-as-a-service platform will help both vendors circumvent traditional adoption hurdles by directly connecting them with digitally equipped customers. Secondly this would also potentially provide access to Tempus' extensive real-world datasets to refine models and potentially expand portfolios across Tempus' broad datasets. Given Tempus' history of strategic acquisitions, including Ambry Genetics and radiology AI company Arterys (Acquired by Tempus Labs), this collaboration could potentially set the stage for a future acquisition if things go well!
- Continuing the trend of AI vendor announcements, Paige has recently expanded PanCancer Detect from 17 to over 40 tissue and organ types. This development aligns with one of Signify Research Ltd's key predictions for 2025: that Digital Pathology AI vendors would leverage generative AI to accelerate portfolio expansion. The enhancement was driven by Virchow V2, trained on 3.1 million slides and over 630 million parameters. While Paige’s competitive positioning has been somewhat uncertain in recent months, it's worth noting that its FullFocus image viewer—through which PanCancer Detect is available—received 510(k) clearance last month for two additional scanners, bringing the total to three. Furthermore, Paige's products will soon be accessible on established platform partners, including PathPresenter, Aiforia, Indica Labs, PathAI, and Gestalt. Despite recently turning its attention back to pharmaceutical collaborations it's clear that Paige hasn't given up on strengthening its position in the clinical space.
- Next, congratulations to Ibex Medical Analytics, which received its first 510(k) clearance from the US Food and Drug Administration (FDA) for Ibex Prostate Detect. This AI-powered software generates heatmaps to assist in identifying small and rare prostate cancers which may otherwise have been missed. Ibex has positioned the technology as a "safety net" for pathologists, presenting it as a low-risk entry point for AI integration into the pathology workflow. FDA approvals for Digital Pathology AI remain rare, making this a significant milestone for the company. However, as I previously highlighted, widespread adoption is still a challenge. Beyond regulatory approval, ongoing market education, the evolution of sales channels and business models, and clinical studies demonstrating direct improvements in patient outcomes will likely play a more critical role in driving vendor success and technology uptake in the long term. With the workforce at the FDA reportedly (somewhat) reinstated I'm sure we'll see more approvals to come this year!
- Sectra announced a customer win this month, with the William Osler Health System in Brampton, Ontario, initiating a digital pathology pilot project in collaboration with Sectra, an imaging IT provider. This initiative is part of Osler’s 10-year enterprise imaging strategy, designed to enhance diagnostic workflows by seamlessly integrating digital pathology into existing imaging systems. Over the past few years, several Enterprise Imaging–Digital Pathology vendor partnerships have been announced. While these collaborations have yet to significantly impact revenue growth, digital pathology is increasingly being included in enterprise imaging tenders across key global markets. As a result, vendors that have invested in these solutions are likely to start seeing the rewards of their efforts in the long-term as long-term strategies like this unfold. In my recent conversations with pathologists, many have emphasised that seamless integration of pathology software with existing PACS and VNA infrastructure is critical for future healthcare implementations. If you're keen to know more about this market I'd encourage you to reach out to Amy Thompson to learn more about our coverage of the enterprise imaging landscape.
- Deciphex has extended a prior partnership with Charles River Laboratories. This collaboration aims to deliver an integrated solution, powered by the Patholytix platform across the CRO's network, allowing users to manage, share, and archive toxicologic pathology data. Building on the 2024 launch of Foresight, the partnership will further refine Deciphex’s AI-powered solutions for toxicologic pathology. These enhancements will expand tissue and lesion coverage while utilising foundational models to extend AI applications into new areas, such as screening tools for acute toxicity and carcinogenicity studies. Deciphex has established a strong market presence in pharmaceutical toxicology applications, making it a challenging competitor for new entrants in this domain.
- Optiscan Imaging Ltd launched its latest product, InForm. InForm is a microscopic medical imaging device that digitally images tissue samples without needing to produce a slide. The company is targeting clinical use with this system, citing intraoperative consultations. Further developments with InForm are expected in the coming months, including integration into a cloud-based telepathology streaming platform. This could be especially beneficial in Australia, where pathology samples are often transported to major cities for analysis, improving access for rural and remote areas. Solutions like this are set to compete with low-throughput scanners and direct-to-digital systems from companies such as SamanTree Medical and Grundium. While direct-to-digital scanning offers the appealing prospect of bypassing certain aspects of slide preparation, Optiscan’s samples will still require topical staining. For a deeper analysis of how these technologies are expected to shape the broader Digital Pathology market in the long term, please feel free to get in touch to learn more about our Emerging Technologies in Pathology topical report.
- Next, Aiforia Technologies has obtained In Vitro Diagnostic Regulation (IVDR) certification securing access to the European market. Alongside this milestone, Aiforia has introduced three new CE-IVD marked AI models designed to support pathologists in breast and prostate cancer diagnostics. These include the Aiforia? Breast Cancer HER2 AI model, which assists in evaluating HER2 status in breast cancer tissue samples, and the Aiforia? Prostate Cancer Gleason 4 Cribriform and Perineural Invasion (PNI) AI models, which help identify specific patterns in prostate tissue. Having multiple algorithms with regulatory approval is important as it enables companies to broaden commercial pricing strategies, enabling economies of scale in purchasing models and encouraging broader adoption.
- Finally, DoMore Diagnostics has been awarded a NOK 16 million grant from the Research Council of Norway's Innovation Project for the Industrial Sector 2024. This funding will support a project titled "Novel AI-based biomarker to predict minimal residual disease and personalize treatment in colorectal cancer". The initiative seeks to evaluate and validate the prognostic value of the company's digital biomarker, Histotype Px? Colorectal, both independently and in combination with circulating tumour DNA (ctDNA), in stage II and III colorectal cancer patients. As more companies introduce similar solutions, digital companion diagnostics (CDx) are edging closer to routine clinical practice. These solutions have a higher likelihood of securing reimbursement, as seen with other algorithms in the US, which, in turn, could drive greater adoption of Digital Pathology and encourage labs to scale up scanning infrastructure.
?That’s all for this month!
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Imogen joined Signify in 2018 as part of the Healthcare IT team. She holds a 1st class Biomedical Sciences degree from the University of Warwick. Since joining the team Imogen has studied various healthcare markets and is now expanding Signify Research’s coverage in Diagnostic and Life Science markets. She has published reports on Breast Imaging, General Radiography, AI in Drug Development and Clinical Trials, LIS/LIMS, digital pathology, oncology IT, and Real-World Data.
Lizzie joined Signify Research in January 2025 as a Market Analyst within the Diagnostics & Life Sciences team. She holds a BSc in Biology from the University of Leeds with an industrial placement year at Amgen where she worked in patient safety. In her free time, Lizzie enjoys travelling, experimenting with new recipes, watching sports and learning how to play golf.
The Diagnostics and Lifesciences team provides market intelligence and detailed insights on the multiple healthcare technology markets where the clinical world intersects with the preclinical. Our areas of coverage include digital pathology, laboratory information systems, clinical Real-World Data (cRWD) platforms, oncology information systems, tumour board software, oncology decision support software and radiotherapy IT. Each report provides a data-centric and global outlook of its markets with granular country-level insights. Our research process blends primary data collected from in-depth interviews with healthcare professionals and technology vendors, to provide a balanced and objective view of the market.
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Solutions Architect, Full stack developer, Pathologist and future ML/AI engineer
1 天前Thank you for putting this together. very helpful.