Recently PathAI announced exciting news: AISight® Dx has received FDA clearance for primary diagnosis in clinical settings! Check out our full press release for more details on the news.
Following AISight Dx’s FDA milestone, we sat down with PathAI Co-Founder and CEO Andy Beck to explore what the clearance means for our customers and the future of digital pathology. Read on for Andy’s insights—and share your thoughts in the comments.
Q: First of all, congratulations on the FDA clearance! A lot of work went into this from the whole team. Can you tell us what the clearance covers, and why this is such a big deal for PathAI?
Andy Beck: Thank you—we couldn’t be more excited about the news. This clearance is really central to our mission at PathAI, which is to improve patient outcomes through AI-powered pathology. The first step in enabling that is giving labs and physicians access to a robust digital pathology platform, which this 510(k) clearance advances.
This is a clearance for primary diagnosis, meaning that our customers can adopt AISight Dx as their primary diagnostic platform and use AISight Dx “out of the box” for clinical purposes. In essence, this clearance marks a pivotal step toward transitioning pathology from traditional microscopy to a fully digital future—advancing not only PathAI’s mission, but setting a precedent for the entire industry.
Q: This isn’t PathAI’s first time to the FDA rodeo. The company attained an earlier 510(k) for a previous version of AISight Dx. What prompted the new clearance now?
A: We received a 510(k) clearance for an earlier version of AISight Dx several years ago, but the platform has evolved tremendously since then. Over time, we’ve gathered invaluable feedback—especially from pathologists—on what they truly need from AISight Dx and a digital pathology platform as a whole.
At PathAI, we’re deeply customer-centric, and that feedback has been instrumental in shaping our roadmap. We've implemented major enhancements to support pathologist workflows, improve efficiency, and enable seamless collaboration. The result is a significantly transformed platform—so much so that it warranted a new 510(k) submission.
This latest clearance reflects AISight Dx as a next-generation digital pathology platform, built through years of iteration, learning, and partnership with our users. It’s not just an update—it’s a reimagined solution that raises the bar for what digital pathology can deliver.
Q: This 510(k) clearance also includes a Predetermined Change Control Plan (PCCP), a recent FDA offering in the 510(k) process. Can you talk about what the PCCP does, and what it covers for PathAI in this clearance?
A: The Predetermined Change Control Plan (PCCP) is a relatively new addition to the FDA’s 510(k) framework, and it’s a significant advancement—especially for software-based medical devices. Essentially, a PCCP outlines a pre-approved strategy for making specific updates to a product without needing to go through a separate FDA submission for each change.
For companies like PathAI, where innovation moves quickly—our teams iterate in six-week development cycles—this is a major enabler. It allows us to continue evolving AISight Dx while maintaining regulatory compliance.
Our overarching goal is to make AISight Dx as accessible and interoperable as possible across a wide range of lab environments. While this clearance includes support for two specific scanners—the Leica Aperio® GT450 Dx and the Hamamatsu NanoZoomer® S360MD—the PCCP gives us the flexibility to expand support in a timely, streamlined way. That includes adding new slide scanners, display types, file formats, and web browsers. We’ve already identified several scanners that we plan to integrate through this pathway, and the PCCP will allow us to bring those capabilities to users faster and more efficiently.
Q: What are you most excited about in this clearance for AISight Dx? Is there a feature that really stands out to you for a modern, digital-forward pathology lab?
A: Broadly, I’m most excited by how this clearance will accelerate the adoption of AISight Dx as the central digital pathology platform across labs, health systems, and academic medical centers. This clearance allows labs that are already digital—or planning to go digital soon—to view slides, collaborate with colleagues, and store images through an IMS that integrates with their laboratory information system (LIS) for anatomic pathology workflows.
But beyond the technical milestone, I’m especially proud of what we’ve built for the pathologist experience. AISight Dx is pathologist-centric, and we’ve optimized the design for fast, seamless navigation and enabling an integrated clinical workflow. We've reimagined classic tools like the multi-headed microscope and translated their value into the digital space.
For example, for complex cases, we’ve built robust synchronous and asynchronous collaboration tools. Our “AISight Live” feature mimics a modern multi-headed microscope, allowing many pathologists to review the same image together in real time. And if someone isn’t available in real time, they can still receive a link with exact instructions on what to review later. These features are really powerful for group diagnostics and for enabling teaching moments.
Q: Are there specific types of labs who will benefit the most from this 510(k) clearance?
A: AISight Dx was built to serve the full range of anatomic pathology labs—from small independent practices to large reference labs, academic medical centers, and integrated health systems.
We also designed the platform to support labs wherever they are in their digital pathology journey. We’ve seen significant acceleration in digital adoption just over the last two years. PathAI helps labs at all points on that journey, whether they’re doing a pilot phase for one specialty; actively scaling up to digitize their full slide volume; bringing on their first digital pathology vendor; or already fully digital and looking for a next-gen platform.
On that front, many of our customers are already asking “what’s next?” They’re thinking beyond the first generation of digital pathology tools and want a platform that not only provides standard viewing and image management, but also sets them up for the future. For example, they want to be ready for algorithms in every part of anatomic pathology, from collaboration to case assignment, diagnostic sign-out, biomarker measurement, and companion diagnostics.
These areas also tie into drug development, such as identifying patients for clinical trials or matching them with newly-approved therapies. Typically, the journey begins with digitization, and then the next step is integrating AI. So this 510(k) clearance benefits everyone in the anatomic pathology community, whether their main concern is meeting compliance requirements; focusing on some other priority, such as usability or workflows; or integrating with biopharma R&D.
Q: This has been great. Do you have any parting thoughts for our readers?
A:PathAI is setting the standard in clinical workflow, image viewing, artifact detection, and digital collaboration. This 510(k) clearance isn’t just a regulatory milestone—it’s a meaningful validation of AISight Dx as a best-in-class product. Labs shouldn’t adopt AISight Dx simply because it’s FDA cleared, but because it delivers an exceptional experience for pathologists, particularly when it comes to usability and real-time collaboration. And while this clearance is a major achievement, it’s just the beginning. We’re building a future where AI-powered digital pathology transforms the way care is delivered—and AISight Dx is at the heart of that vision.
As the whole world moves towards AI, it’s more important than ever for labs to base their digital pathology strategy on best-in-class, holistic software. Learn more about AISight Dx and reach out to us for a free demo.
AISight® is for Research Use Only in the US; AISight® Dx is FDA 510(k)‑cleared for clinical use in the US with the Hamamatsu NanoZoomer® S360MD and Leica Aperio® GT 450 DX slide scanners, and is CE‑IVD–marked for primary diagnosis in the EEA, UK, and Switzerland.