March 2025 Digital Pathology Roundup

March saw major developments across digital pathology, including regulatory milestones, foundational AI models, strategic partnerships, and significant funding wins. Regulatory Approvals: Epredia earned FDA 510(k) clearance for its high-volume E1000 Dx Digital Pathology Solution, capable of digitizing up to 1,500 slides per day. Despite the hardware’s impressive capacity and features like dual slide processing and automated quality control, its immediate clinical appeal may be tempered by institutions’ preference for redundancy over sheer throughput. Still, Epredia’s longstanding customer trust and emphasis on quality may help drive early adoption. Meanwhile, PathAI received EMA qualification for its AIM-MASH AI tool, which standardizes biopsy scoring for MASH trials—well timed given the FDA’s recent approval of the first drug for the condition. Foundation Models & Large Datasets: Bioptimus launched ‘H-optimus-1,’ a massive pathology foundation model trained on over 1 million H&E slides from 800,000+ patients. It more than doubles the dataset used for their previous model and builds momentum following January’s major funding round. At HIMSS, HistAI debuted its SPIDER initiative, aiming to create a 50-million-image open-source dataset covering 20 organs. The first release includes 3 pretrained models targeting skin, colorectal, and lung—an ambitious step toward accelerating AI discovery and collaboration. Partnerships: Quest Diagnostics teamed up with Google Cloud to deploy generative AI for enhanced data analytics and customer experience. While not immediately diagnostic, such tools are paving the way for future clinical AI applications. Funding: Proscia raised $50 million in a round led by Insight Partners, boosting its total funding to $130 million. The funds will support platform adoption, AI enhancements, and deeper collaborations with Agilent and Siemens. The company also hinted at a future IPO—marking a promising trajectory for this digital pathology innovator.