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Ketryx Raises $39 Million Series B to Scale AI Compliance Platform for Life Sciences

It pitches real-time compliance for FDA and EU MDR workflows to help teams ship safer products faster.

Overview

  • Transformation Capital led the round, with participation from Lightspeed, MIT’s E14 Fund, Ubiquity Ventures, 53 Stations, and former Medtronic CEO Bill Hawkins, and Transformation Capital’s Vinay Shah will join the board.
  • This financing lifts total capital raised to more than $55 million and will fund Vienna expansion, faster hiring in Austria and Boston, product development, and global rollout.
  • The platform uses AI-driven compliance agents that integrate with tools like Jira and GitHub to automate documentation, validation, and end-to-end traceability for regulated programs.
  • Ketryx says customers report up to 90% reductions in documentation time and more than 10x faster release cycles, with AI that flags validation gaps and helps triage safety issues.
  • Adoption includes three of the world’s top five medtech companies and AI diagnostics customers such as DeepHealth, HeartFlow, and Aignostics.