Ketryx Raises $39 Million in Series B to Build the Infrastructure for Regulated AI

Ketryx, Agentic AI for FDA Compliance, led by Erez Kaminski, Jan Pöschko, Mary Brook Delano, Brian Katzman, and Paul Jones, has announced $39 million in Series B funding, led by Transformation Capital. Vinay Shah, Partner and founding team member, will join the Ketryx board, bringing the total funding to over $55 million, with participation from existing investors: Lightspeed Venture Partners, MIT's E14 Fund, Ubiquity Ventures, and 53 Stations.

The life sciences industry struggles with slow product cycles due to compliance burdens, delaying critical innovations for patients. Ketryx eliminates this tradeoff by enabling zero-lag compliance, where documentation and traceability are generated in real time. Trusted by three of the world’s top five MedTech companies, Ketryx empowers regulated industries to release AI-driven products faster and more safely, closing the gap between innovation and patient impact.

AI adoption in medical devices is accelerating, from diagnostic tools to robotic surgery, but rising documentation demands under standards like IEC 62304 create a heavy “compliance tax.” Manual processes often consume 50–80% of development time, slowing innovation and patient impact. Ketryx addresses this by automating compliance for the AI-native, continuously deployed reality of modern medical devices. In 2024 alone, 2% of all FDA approvals for AI/ML-enabled devices were built on Ketryx, proving its role in enabling faster, safer innovation.

Ketryx has become the infrastructure enabling Fortune 500 life sciences companies to develop and ship regulated AI at unprecedented speed, every one to two weeks instead of every two years, powering products that already impact over 25 million patients annually. Combining an AI-native platform with deep regulatory expertise from healthcare, defense, aerospace, pharma, and MedTech, Ketryx delivers both technology and guidance for compliance at scale. With Series B funding, the company aims to expand globally, targeting 100 million patients served by 2030.

Ketryx’s AI-native platform eliminates compliance bottlenecks by automating documentation, traceability, and validation workflows, generating real-time evidence as code is written. This approach has enabled Medtronic’s Nutrino team to cut SBOM documentation time by 90%, Beacon Biosignals to achieve two-week release cycles with multiple FDA approvals, Radnet/DeepHealth to deploy four FDA-cleared diagnostic products delivering 1.3M+ AI diagnoses annually, and Heartflow to reduce complexity by 90% while supporting over 400,000 patients.

The life sciences industry faces a pivotal moment: AI’s potential is immense, but legacy compliance systems and risk concerns stall innovation. Ketryx’s Series B funding accelerates product roadmap and AI agent development, deepens integrations with leading tools, and supports global enterprise expansion. The vision is a future where safety and innovation advance together, enabling zero-lag compliance, faster release cycles, safer products, and life-saving therapies reaching patients months or years sooner.