Paige
FDA-cleared AI for cancer pathology, from digital slide viewing to cancer detection algorithms.
About
Paige builds AI for pathology labs, focused on cancer diagnosis. Its FullFocus digital pathology viewer received FDA 510(k) clearance in January 2025 for use with Leica, Hamamatsu, and Philips scanners, making it one of the more scanner-compatible viewers on the market. The company's detection algorithms include Paige Prostate Detect, described in company announcements as the first FDA-approved AI algorithm for detecting prostate cancer in core-needle biopsies. Paige also holds FDA Breakthrough Device Designations for Paige Lymph Node and Paige PanCancer Detect. In April 2025, Burjeel Holdings partnered with Paige to deploy its tools across the MENA region.
The honest picture: Paige's tools are decision-support aids for pathologists, not replacements. Adoption still requires labs to go digital first, which is its own capital project, and regulatory clearance covers specific scanner pairings, so labs need to check compatibility before buying in.
What it can do
- FullFocus FDA-cleared digital slide viewer
- Paige Prostate Detect cancer detection in biopsies
- Paige Breast and PanCancer detection algorithms
- Multi-scanner compatibility (Leica, Hamamatsu, Philips)
- Breakthrough-designated lymph node metastasis detection
Setup
Contact Paige for an enterprise deployment. Labs need a compatible whole-slide scanner (Leica Aperio GT 450 DX, Hamamatsu NanoZoomer S360MD, or Philips IntelliSite UFS) and IT infrastructure for digital slide storage. Paige integrates its viewer and detection algorithms into the lab's existing workflow.
Prerequisites
A digital pathology setup with a supported scanner; enterprise contract with Paige; pathologists to review AI-flagged findings.
Use cases
Works with
Trust score — 8/10
Scored 8/10 (verified tier, metrics-v1). Evidence: FullFocus viewer FDA 510(k) clearance Jan 2025 (K241273) for Leica, Hamamatsu, Philips scanners, reported via BioSpace/AP; Paige Prostate Detect described as first FDA-approved AI algorithm for prostate cancer in biopsies; FDA Breakthrough Device Designations for Lymph Node and PanCancer Detect; Burjeel Holdings MENA deployment partnership April 2025.
Sources
Every fact above was checked against these sources. Where a claim comes from the provider and couldn't be independently verified, the text says so.