January 2025 Digital Pathology Roundup

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.