PathAI

From Manual to Digital: AISight®’s Fast, Flexible Onboarding 🔬 Moving to digital pathology isn’t just a tech upgrade. It is a workflow transformation. Our new blog shows how AISight® helps labs incorporate research tools quickly, including cloud native scaling and seamless scanner and LIS integration. See how PathAI’s Implementation and Customer Success teams partner with you from workflow mapping to hands on training and ongoing optimization. Read the blog to learn more. #Pathology #DigitalPathology #LabOperations #AISight #PathAI AISight is for Research Use Only in the US. AISight® Dx is FDA cleared for primary diagnosis in the US and CE IVD marked in the EEA, UK, and Switzerland.

Let’s talk about a game-changing FDA (U.S. Food and Drug Administration) framework: the Predetermined Change Control Plan (PCCP). 📘 Think of it as an FDA approved upgrade blueprint: once authorized by the Agency, manufacturers can validate and implement specified device modifications by running a predefined test suite without needing a new 510(k) submission. This framework paves the way for faster innovation while maintaining ongoing FDA compliance. 🌟That’s where AISight® Dx shines. It’s the first digital pathology image management system (IMS) to secure FDA clearance under a PCCP joining fewer than 60 PCCP‑authorized devices in the entire 510(k) database as of July 2025. This proactive regulatory alignment accelerates future software updates and hardware integrations, allowing faster innovation while ensuring continued FDA compliance. Learn more about AISight Dx: https://lnkd.in/e-tUA2ZH Reach out to us to explore more: digitaldx@pathai.com #DigitalPathology #PCCP #FDA510k #PathAI #Innovation AISight® Dx is FDA-cleared for primary diagnosis in the US and is CE‑IVD–marked for primary diagnosis in the EEA, UK, and Switzerland.

AISight® Dx is now FDA-cleared for primary diagnosis—marking a major milestone for PathAI and the future of digital pathology. We sat down with our CEO and Co-Founder, Andrew Beck, M.D., Ph.D., to discuss what this clearance means for labs, pathologists, and the entire field of anatomic pathology. From improved clinical workflows to real-time collaboration tools and future-ready algorithm integration, AISight Dx is redefining what a digital pathology platform can deliver. #DigitalPathology #FDA510k #AISightDx

PathAI scientists and partners have recently published “Comprehensive characterization of granular fibrotic and cellular features in liver tissue enabled by deep learning models” on medRxiv, which details the development of our solution, Liver Explore, which provides quantitative spatial insights into liver pathology. 📃 Read the publication: https://lnkd.in/eyzc3mTQ 🔬 Pathologists rely on visual evidence of disruption of normal liver microarchitecture – inflammation, cellular injury, steatosis, and fibrosis – when evaluating a biopsy. However, manual assessments of liver histology are not quantitative or scalable, particularly for evaluating spatial relationships between histological substances. Especially given the need to assess fibrosis using special stains or imaging, an opportunity exists to gain a more in-depth understanding of liver disease histology from routine, H&E-stained biopsies. 🔍 In this paper, we detail the development and utility of Liver Explore, an AI pathology tool that exhaustively classifies and quantifies tissue regions, cell types, lobular zones, and fibrosis subtypes from whole slide images of H&E-stained liver biopsies at scale. Using specimens from two MASH clinical trials, we validate Liver Explore outputs against pathologist annotations and orthogonal measurements of disease biology. We also demonstrate Liver Explore’s ability to 1) reveal changes in liver composition with increasing disease severity and 2) yield histologic features that associate with liver-related events, such as progression to cirrhosis. These results highlight both the wealth of information present within liver biopsies and the ability of Liver Explore to reveal it. Liver Explore is for research use only; not for use in diagnostic procedures. #AI #AIPathology #digitalpathology #liver #hepatology #pathology #fibrosis #MASH #biomarkers #clinicaltrials

🌟 Introducing the Precision Pathology Network (PPN) 🌟 PathAI is pleased to announce the launch of the Precision Pathology Network—a global network of digitally enabled pathology laboratories connected through PathAI’s AISight® Image Management System (IMS) to advance AI-driven diagnostics and precision pathology. What the PPN delivers for labs and biopharma partners: 🔬 Early AI Access Priority access to next‑generation algorithms from PathAI, so your lab can deploy them on day one. 💰 New Revenue Pathways via Real‑World Data A secure, standardized framework for contributing de‑identified whole‑slide images, pathology reports, and molecular data to biopharma‑sponsored research and discovery projects. 🤝 Evidence‑Generation Opportunities Demystify “evidence generation readiness” with expert guidance on consistent data collection and strict protocol adherence—empowering your lab to compete for and win high-value, data-driven studies. 🚀 AI‑Powered Trial Acceleration Leverage proprietary assays such as MET-Predict™ for high-accuracy identification of MET-amplified tumors to streamline patient screening and enrollment in clinical trials. 🧬 Advanced Precision‑Medicine Tools Access PathAI’s Explore™ biomarker-discovery suite via AISight and the PLUTO foundation model for novel research, grant collaboration, and custom AI co-development. Whether you’re a reference lab, academic medical center, community pathology group, or a biopharma team accelerating clinical development, the PPN turns digital pathology into a growth engine—while ultimately improving patient care. Ready to unlock the full power of digital pathology? Join the PPN and discover how seamless collaboration, day-one AI readiness, and revenue-driving real-world data can elevate your organization. 🔗 Learn more about Precision Pathology Network here: https://lnkd.in/eCvkjude 📄 Read the full press release here: https://lnkd.in/eMxWgxsn 📩 To schedule a meeting for more information, please reach out to digitaldx@pathai.com AISight® is for Research Use Only in the US; AISight® Dx is FDA-cleared for clinical use in the US and is CE‑IVD–marked for primary diagnosis in the EEA, UK, and Switzerland. MET Predict™ and Explore™ Suite are for research use only and not for use in diagnostic procedures. #DigitalPathology #AIPathology #PrecisionMedicine #RealWorldData #ClinicalTrials #PathologyLabs #Biopharma

🧬🗞️ Big news!! PathAI has received FDA clearance for AISight® Dx for use in primary diagnosis, marking a major milestone in the advancement of digital pathology for clinical care. AISight Dx is a cloud-native digital pathology Image Management System (IMS), built to modernize anatomic pathology workflows. With intelligent case management, high-performance slide review, and seamless collaboration, AISight Dx helps labs boost efficiency, improve diagnostic consistency, and support high-quality patient care. This clearance also includes a Predetermined Change Control Plan (PCCP)—allowing PathAI to validate and implement future enhancements—such as additional scanners, displays, file formats, and browsers—without requiring new 510(k) submissions. This framework paves the way for faster innovation while maintaining ongoing FDA compliance. This milestone not only reinforces PathAI’s leadership in digital pathology, but also ushers in a new era of continuous innovation—enabling labs to confidently adopt future-ready capabilities and accelerate the path toward smarter, more efficient diagnostics. 📄 Read the full press release here:https://lnkd.in/eHJs5mtb 🔗 Learn more about AISight Dx here: https://lnkd.in/e-tUA2ZH AISight® Dx is FDA-cleared for primary diagnosis in the US with the Hamamatsu Corporation NanoZoomer® S360MD and Leica Biosystems Aperio® GT 450 DX slide scanners, and is CE‑IVD–marked for primary diagnosis in the EEA, UK, and Switzerland. #FDAclearance #AISightDx #DigitalPathology #PathAI #PCCP #PrimaryDiagnostics #RegulatoryMilestone

PathAI is heading to European Society of Digital and Integrative Pathology - ESDIP's ECDP 2025 in Barcelona! 📍 Join us at Booth 4 from June 25 to June 28, 2025, to explore how AI is shaping the future of digital pathology. Stop by to:   🔬 Hear Max Zinner, Head of Digital Diagnostics Europe at PathAI, deliver an AI Innovation Talk—“AIM-TumorCellularity: AI-Driven Tumor Sufficiency Assessment Across Tumor Types”—on Friday, 27 June 2025, at 14:00 CEST in the Main Auditorium.   🔬Check out Dr. Jan-Niklas Runge (Department of Pathology and Molecular Pathology, University Hospital Zurich) in Poster P66: “Real-World Performance of AI-Based Tumor Cell Content Quantification.” We look forward to showing you how the AISight® Image Management System is advancing digital pathology and transforming the role of AI and machine learning in digital diagnostics. 📥 To schedule a meeting: https://lnkd.in/dAJwhkd9 🔗 Event details:https://www.ecdp2025.org/ #ECDP #ECDP2025 #pathology #digitalpathology #AISight #ImageManagementSystem AISight® is for Research Use Only in the US,  AISight® Dx is CE-IVD marked in the EEA, UK, and Switzerland.

🔬 We’re thrilled to share that PathAI’s CEO, Andrew Beck, will be speaking at the 36th Pezcoller Symposium on Studying and Treating Cancer in the Digital Era — taking place June 23–24 in Trento, Italy. 🎙 On June 24, Andy will present “𝑨𝑰-𝑷𝒐𝒘𝒆𝒓𝒆𝒅 𝑷𝒂𝒕𝒉𝒐𝒍𝒐𝒈𝒚: 𝑺𝒄𝒂𝒍𝒊𝒏𝒈 𝑷𝒓𝒆𝒄𝒊𝒔𝒊𝒐𝒏 𝑪𝒂𝒏𝒄𝒆𝒓 𝑫𝒊𝒂𝒈𝒏𝒐𝒔𝒕𝒊𝒄𝒔 𝒊𝒏 𝒕𝒉𝒆 𝑫𝒊𝒈𝒊𝒕𝒂𝒍 𝑨𝒈𝒆”, highlighting the work PathAI is doing to transform pathology. This prestigious gathering brings together global leaders in oncology, computational biology, and data science — and we’re honored to be part of this collaborative push toward transforming cancer care. 📍 Learn more about the event: https://lnkd.in/e5GX_VvA #PathAI #PezcollerSymposium #DigitalPathology #ArtificialIntelligence #PrecisionMedicine #OncologyInnovation

🚀 We’re thrilled to share that our CEO, Andrew Beck, has been named one of the 2025 Tech Power Players by The Boston Globe! This honor reflects not just Andy’s visionary leadership, but also the collective impact of our team at PathAI—pioneering advancements in AI-powered pathology aiming to improve patient outcomes. We're proud to be part of New England's vibrant tech and life sciences community, and we're just getting started. 👉 Read more about the Tech Power Players 50 and the transformative work shaping the future of technology: https://lnkd.in/e8XuQeDM #PathAI #TechPowerPlayers #AIinHealthcare #DigitalPathology #BostonTech

Just two days until the 2025 Digital Pathology & AI Congress (#DPAI2025)! PathAI can’t wait to show you how the AISight® Image Management System is advancing digital pathology and transforming the role of AI and machine learning in digital diagnostics. We look forward to seeing you at Booth #26! 📩 To schedule a meeting: digitaldx@pathai.com 🔗 Event details: https://lnkd.in/eGH7RuZs #DigitalPathology #AISight #ImageManagementSystem #PathAI AISight® is for Research Use Only in the US; AISight® Dx is CE-IVD marked in the EEA, UK, and Switzerland.