Austrian-American Ketryx, the AI-powered compliance platform helping life sciences companies ship safer products faster, today announced a $39 million Series B, bringing the company’s total funding to over $55 million.
Life sciences teams face the challenge of balancing strict compliance requirements with the accelerating pace of innovation. Despite advances in cloud tools and LLMs, most still rely on infrastructure not built for this speed of change.
Ketryx addresses this gap by automating validation, traceability, and regulatory workflows, including FDA and EU MDR-ready documentation, across the product development lifecycle. The result is safer products delivered faster, with customers reporting up to 90 per cent less documentation time and release cycles more than 10 times quicker.
Erez Kaminski, CEO and founder of Ketryx, shared:
I’ve spent the last decade at the intersection of AI and life sciences, watching it evolve from an emerging tool to a critical application for patients. It’s now time to accelerate adoption and ensure AI is safe, reliable, and ready for regulated environments.
The company’s platform is built for the enterprise and already used by three of the top five global medtech companies, several Fortune 500 organizations, and AI-powered companies such as DeepHealth, Heartflow, and Aignostics.
With adoption accelerating, Ketryx is emerging as the key AI infrastructure layer for product development in regulated industries.
The round was led by Transformation Capital, with participation from existing investors including Lightspeed Venture Partners, MIT’s E14 Fund, Ubiquity Ventures, and 53 Stations.
Bill Hawkins, former CEO of Medtronic and new Ketryx investor, said:
In medtech, long-term success depends on balancing innovation with the uncompromising demands of safety and compliance. This balance has historically been hard to achieve. Ketryx has built the infrastructure that allows both to advance together. Their ability to deliver this level of rigor at true enterprise scale is why I’m proud to support them as they shape the future of regulated software.
As part of this latest round, Vinay Shah, Partner and Founding Team Member at Transformation Capital, will join Ketryx’s board. According to Shah, medtech teams are at the forefront of using AI to enhance patient outcomes while ensuring their products adhere to the strictest safety and regulatory requirements. He commented:
In our diligence, Fortune 500 giants and fast-growing innovators consistently praised Ketryx for proving that compliance can accelerate, rather than slow, technological progress. We believe Ketryx is defining the future of regulated infrastructure across industries and are proud to back them in their next stage of growth.
Kaminski continued:
Having Transformation Capital, the pre-eminent digital health VC & growth equity firm, as our lead partner, gives us more than just capital. They understand exactly what it takes to build and scale healthcare technology companies.
With their backing and industry connections, we’re continuing our global expansion, accelerating our product roadmap, and hiring rapidly in both Boston and Austria.
By enabling real-time traceability and documentation, Ketryx integrates zero-lag compliance into product development, helping teams release safer products faster and at scale.
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