Ketryx Secures $39M Series B for AI Medical Device Compliance

Ketryx has raised $39 million in a Series B funding round. Notably, Transformation Capital led this investment. The company develops an AI-native compliance platform for medical device manufacturers.

This round brings Ketryx's total funding to over $55 million. Existing investors, including Lightspeed Venture Partners, MIT’s E14 Fund, Ubiquity Ventures, and 53 Stations, also participated. Consequently, Ketryx, founded in 2021, aims to accelerate product development while maintaining rigorous safety standards.

Advancing Medical Device Safety with AI

Ketryx's platform combines multiple AI models and agents. Specifically, it automates validation, traceability, and regulatory compliance. This includes documentation for the U.S. Food and Drug Administration and the European Union’s Medical Device Regulation.

The system is built for enterprise-scale compliance. Three of the world’s top five medical technology companies currently utilize the platform. Additionally, customers include AI-powered radiology firm DeepHealth Inc. and cardiac diagnostics company Heartflow.

Ketryx significantly cuts documentation time, reducing it by up to 90%. Furthermore, its AI agents identify validation gaps human reviewers might miss. The platform also assists in triaging safety complaints and suggesting design modifications post-release. Biomedical data startup Aignostics GmbH also uses Ketryx's solution.