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year
Custom based on contract
project
Per clinical trial engagement
Pricing sourced from PathAI ยท Last verified March 2026
Yes. PathAI received FDA 510(k) clearance for AISight Dx for primary diagnosis, and in 2025 obtained clearance with a Predetermined Change Control Plan (PCCP) that allows specific AI enhancements without new regulatory submissions.
PathAI uses enterprise pricing with per-site licenses or usage-based models tied to slide volumes and specific AI applications. Biopharma projects are structured as separate service engagements. It is not positioned as a tool for small private labs.
PathAI's algorithms cover multiple tumor types including breast, lung, head and neck, and gastrointestinal cancers, with specific applications for tumor detection, grading, and biomarker quantification like PD-L1 and HER2.
Yes. AISight is designed to integrate with existing LIS and LIMS workflows, serving as a centralized hub that connects case management, image management, and AI applications within existing laboratory infrastructure.
AI builders and operators use PathAI to streamline their workflow.
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