The June Digital Pathology Roundup with Imogen Fitt of Signify research is here.

Funding:
• RainPath AI raised €2.5M from Teampact.ventures, Xplore by Épopée Gestion, The Quest, Advance Lab, SHARPSTONE, about 15 angels, and Bpifrance. RainPath builds AI tools for virtual staining, smarter slide analysis, and structured reporting to cut reagent use and ease diagnostic bottlenecks. Funds will double headcount and advance product development and clinical validation.
• PreciseDx closed $11M led by Eventide, Merck GHI, and Philips Ventures, with Labcorp, Quest, GenHenn, and others. Eric Converse was named CEO and Ed Sitar CFO. Proceeds support more clinical data, commercial expansion, and prep for a 2026 launch of PreciseBreast, which provides phenotypic and grading insights to predict breast cancer recurrence risk.

Regulatory:
• PathPresenter received FDA 510(k) for its Clinical Viewer for primary diagnosis, cleared with Hamamatsu NanoZoomer S360MD NDPI images on a Barco NV MDPC8127 display. Broader device and file support is expected.
• PathAI secured FDA 510(k) for AISight Dx IMS for primary diagnosis with Hamamatsu S360MD and Leica Aperio GT 450 DX scanners; the IMS was first cleared in 2022 with the Philips Ultra-Fast Scanner. The FDA also approved a Predetermined Change Control Plan PCCP, allowing PathAI to add displays, scanners, file formats, and browsers without new 510(k) submissions, speeding platform expansion.
• Evident announced that SLIDEVIEW™ DX VS200 earned the CEIVDR mark in Europe. The scanner supports fluorescence, polarization, darkfield, and phase contrast, adding competitive choice in Western Europe.

Partnerships:
• PathPresenter and CAP unveiled an immersive AI platform for CAP members to trial tools from multiple vendors, launching at CAP25 Sept 13 to 16, Orlando.
• GI Alliance will adopt Lumea Viewer+ for its digital pathology entry, a significant deployment across 900 gastroenterologists and 400 plus sites.
• Leica extended its CDx collaboration with Bristol Myers Squibb. Parent Danaher formed another CDx partnership with AstraZeneca.
• Paige partnered with the Breast International Group to evaluate OmniScreen, focusing on novel biomarkers and real-world performance, especially in rare breast cancer subtypes. Paige also integrated with Roche Navify Digital Pathology.


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