Ketryx Corp., a company transforming product lifecycle development and compliance for medical device makers with artificial intelligence, today announced it has raised $39 million in a Series B funding round led by Transformation Capital.

The round brings Ketryx’s total funding to more than $55 million, with participation from existing investors that include Lightspeed Venture Partners, MIT’s E14 Fund, Ubiquity Ventures and 53 Stations.

Founded in 2021 by Chief Executive Erez Kaminski, Ketryx is building an AI-native compliance platform designed to speed up product development while maintaining rigorous safety standards. Kaminski told SiliconANGLE in an interview he was inspired to launch the company after seeing how long and difficult it was for medical technology firms to bring innovations to market.

“Everything that’s meaningful is regulated,” Kaminski said. “I didn’t even comprehend how hard it could be.”

Medical devices must undergo extensive safety testing and regulatory approvals before reaching patients. That means development teams are constantly balancing compliance with the need to innovate. This development time and compliance approval process is only becoming more complex with the inclusion of AI with medical tech.

“The biggest problem is that it used to take about 50 pages to prove the system works, like a scalpel, but today… that could take 10,000 pages,” Kaminski explained. “And you need to make 10,000 pages every time you make a new version. It’s just really, really difficult to make so much proof as products become more software and AI-driven.”

Ketryx’s platform combines multiple AI models and agents to automate validation, traceability, and regulatory compliance, including 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 and is already in use at three of the world’s top five medical technology companies, though Kaminski declined to name them. Customers include AI-powered radiology firm DeepHealth Inc., cardiac diagnostics company Heartflow Inc. and biomedical data startup Aignostics GmbH.

Diagnostics and radiology are among the fastest medical technology segments to adopt AI, Kaminski noted.

“Medtech teams are leading the way in applying artificial intelligence to improve patient outcomes, creating products that meet the highest safety and regulatory standards,” said Vinay Shah, partner and founding team member at Transformation Capital.

According to Kaminski, Ketryx can cut documentation time by up to 90% and helps compliance teams quickly identify validation gaps that human reviewers might overlook. After products are released, its AI agents also assist in triaging safety complaints, identifying high-risk issues, and even suggesting potential design modifications.

“We’re at a time in history where it doesn’t make sense anymore that the industries that matter the most are delayed because of paperwork,” Kaminksi added. “Finally, there are ways to solve it.”

With its new funding, Kaminski said Ketryx will expand globally, accelerate product development and grow its teams in Boston and Austria.

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