Ketryx Raises $39M Series B to Accelerate AI Medical Device Compliance

Ketryx, an AI-native compliance platform for medical device manufacturers, has raised $39 million in a Series B funding round led by Transformation Capital, bringing its total funding to over $55 million. The platform automates validation, traceability, and regulatory compliance documentation, including FDA and EU MDR requirements, significantly reducing documentation time by up to 90% and accelerating product release cycles by more than tenfold. Ketryx's technology supports medical device companies in balancing innovation with rigorous safety standards, a challenge intensified by the increasing integration of AI in medical products and the complexity of regulatory demands. Its customers include three of the top five global medtech companies, as well as AI firms like DeepHealth, Heartflow, and Aignostics. The company plans to use the new funding to expand globally, grow its teams in Boston and Vienna, and further develop its platform to ensure AI in medical devices is safe, reliable, and compliant. CEO Erez Kaminski emphasized the difficulty of producing extensive documentation required for AI-driven products and the need for automated solutions to accelerate safe innovation in the life sciences sector.