Ketryx secures $39m to boost AI-powered compliance for medical device development

Ketryx Secures $39M to Enhance AI Compliance Platform for Medtech

Ketryx has raised $39 million to accelerate the development of its AI-driven compliance platform tailored for medical device manufacturers. The US-based company focuses on automating documentation, ensuring traceability, and speeding up release cycles for clients working with AI-powered medical devices.

Leading the Series B funding round was Transformation Capital, pushing Ketryx’s total funding beyond $55 million. Existing investors like Lightspeed Venture Partners, Ubiquity Ventures, and 53 Stations also participated. The new capital will support the expansion of Ketryx’s teams in Boston and Vienna, Austria, alongside advancing its product roadmap.

Addressing Compliance and Validation Challenges in Medtech AI

Ketryx’s platform tackles cybersecurity and privacy concerns related to medical device development, with a strong focus on validation protocols. These protocols help manufacturers prove their devices operate as intended. According to CEO Erez Kaminski, the core challenge in building medical devices isn’t just construction but ensuring quality, compliance, and thorough documentation.

“We provide a compliant solution that allows companies to generate all necessary evidence through an AI-powered workflow at the click of a button,” Kaminski explained.

Accelerating AI Integration in Medical Devices

With AI in healthcare projected to reach a $19 billion market value by 2027, medtech companies are increasingly integrating AI not only into their products but also their development processes. Ketryx serves a dual role:

• Speeding up the development of AI-driven medical devices
• Facilitating the use of AI tools during product creation

This approach helps clients produce more qualified, validated AI products while maintaining safety standards.

Balancing AI Automation with Human Oversight

One critical aspect Ketryx emphasizes is ensuring human involvement in decision-making processes that impact patient safety. Kaminski highlighted the risks of AI “hallucinations”—errors where AI provides incorrect information while appearing confident.

“AI generates outputs the same way whether they're accurate or not. The key is to prove that humans approve any significant changes AI suggests,” he said.

Kaminski also noted that for some applications, AI’s performance can statistically match or exceed human capabilities. However, in other cases, maintaining a human in the loop remains essential to validate AI’s effectiveness.

For professionals involved in IT, product development, or compliance within medtech, Ketryx’s platform offers a practical solution to meet regulatory demands while integrating AI technologies efficiently.

To explore more about AI compliance and development tools, visit Complete AI Training.