February 2025 saw significant momentum in Digital Pathology, marked by strategic partnerships, platform expansions, and regulatory progress. Here is the February Round-up with Imogen Fitt of Signify Research.
Indica Labs partnered with Versant Diagnostics to deploy the HALO AP platform across U.S. labs, emphasizing usability, collaboration, and AI integration. Despite FDA approval for the NanoZoomer S360MD scanner, implementation remains complex due to diverse installed scanner bases. Deciphex extended its partnership with Charles River Laboratories, integrating its Patholytix platform to manage toxicologic pathology data. Building on its Foresight AI, Deciphex aims to enhance lesion and tissue coverage, strengthening its dominance in pharma toxicology.
In Digital Pathology–Genomics integration, Myriad Genetics and Lumea teamed up to streamline test ordering through Lumea’s platform, mirroring global trends toward centralized diagnostic systems. Additionally, Imagene and ArteraAI partnered with Tempus AI to distribute AI-powered assays, bypassing adoption barriers and potentially accessing Tempus' real-world datasets. These moves hint at deeper integration and potential acquisitions in the future.
AI portfolio expansion continued, with Paige’s PanCancer Detect growing to cover 40+ tissue types, fueled by Virchow V2 (trained on 3.1M slides). Paige also secured 510(k) clearance for more scanners and increased accessibility via key platforms, signaling renewed clinical focus.
Regulatory approvals were a highlight: Ibex Medical Analytics earned its first FDA 510(k) clearance for Prostate Detect, positioned as a safety net for pathologists. Meanwhile, Aiforia Technologies received IVDR certification in Europe, launching new CE-IVD models targeting breast and prostate cancer diagnostics.
Finally, Sectra announced a digital pathology pilot with William Osler Health System in Ontario, part of a decade-long enterprise imaging strategy. Integration with existing IT systems is increasingly seen as critical, as vendors aim for long-term growth through enterprise imaging tenders globally.