Here is the August Digital Pathology Roundup with Imogen Fitt of Signify Research.

1. Acquisitions:

Tempus AI is buying Paige for $81.25M, mostly in stock. Beyond headlines calling it a “data deal,” Tempus gains Paige’s ~7M de-identified whole-slide images plus seasoned AI/regulatory assets: Paige holds FDA Breakthrough Device Designations and De Novo clearances across prostate, lymph node, and PanCancer Detect. Tempus will also assume Paige’s existing Microsoft Azure cloud commitment.

Microscope maker Evident acquired AI-enabled scanner vendor Pramana—the first notable scanner-vendor acquisition in a while—prompting fresh questions about how hardware and AI stacks will consolidate.

2. Partnerships:

China’s Thorough Future announced a strategic partnership with Leica Biosystems to bring its multi-organ tumor-detection model (lung, stomach, prostate, intestine, lymph nodes) into Leica’s software; details remain light.

KFBIO struck a distribution deal with Malaysia’s CytoVision to bring KFBIO’s scanners, AI, and software to Singapore and Brunei. CytoVision, active since 2023 in digitization and education, already works with two Singaporean hospitals, positioning KFBIO for regional traction.

Techcyte extended its integration spree: (1) Modella AI’s PathChat co-pilot (and research-only PathChat DX, which has FDA Breakthrough status) to help pathologists summarize reports, interpret images, and query slides; and (2) DeepBio’s prostate and frozen-section algorithms. Initial DeepBio integrations will be RUO, with CE-IVD offerings in the portfolio and U.S. access planned via CLIA labs.

3. Regulatory:

ArteraAI secured FDA De Novo authorization for ArteraAI Prostate just 35 days after announcing Breakthrough Device status. It is now the first FDA-authorized AI tool to provide prognostic insights for patients with non-metastatic prostate cancer, and the decision creates a new product code that may streamline pathways for follow-on entrants.