Ketryx Secures $39M Series B to Accelerate AI Compliance in Medical Device Development

Cambridge, MA and Vienna, Austria-based Ketryx, a company specializing in AI-native compliance platforms, has successfully closed a $39 million Series B funding round. This latest investment brings the company's total funding to over $55 million, aimed at speeding up the development and regulatory approval of medical devices and other life science products. The announcement underscores a significant step in addressing the complex compliance challenges faced by the rapidly evolving life sciences sector.

The Series B round was led by Transformation Capital, a prominent digital health venture capital firm. Existing investors, including Lightspeed Venture Partners, MIT’s E14 Fund, Ubiquity Ventures, and 53 Stations, also participated. Notably, Bill Hawkins, former CEO of Medtronic, joined as a new investor, signaling strong industry confidence. As part of the investment, Vinay Shah, Partner and Founding Team Member at Transformation Capital, will join the Ketryx board of directors.

Ketryx’s core offering is an AI-native compliance platform designed to automate validation, traceability, and regulatory workflows, including FDA and EU MDR-ready documentation, across the product development lifecycle. The platform aims to bridge the gap between rapid innovation, especially with the integration of artificial intelligence, and the stringent safety and compliance requirements in life sciences. This approach seeks to eliminate the "compliance tax" that often delays critical product releases.

The company's technology has demonstrated substantial operational improvements for its clients. Customers have reported up to a 90% reduction in documentation time and over tenfold faster release cycles. Ketryx’s platform is currently utilized by three of the top five global medtech companies, several Fortune 500 organizations, and AI-powered healthcare firms such as DeepHealth, Heartflow, and Aignostics.

Erez Kaminski, CEO and founder of Ketryx, emphasized the urgency of their mission, stating, "It's now time to accelerate adoption and ensure AI is safe, reliable, and ready for regulated environments." Vinay Shah of Transformation Capital added, "Fortune 500 giants and fast-growing innovators consistently praised Ketryx for proving that compliance can accelerate, rather than slow, technological progress."

The newly secured capital will fuel Ketryx's global expansion initiatives, accelerate its product roadmap, and support rapid hiring across its offices in Boston and Austria. This strategic investment positions Ketryx to further establish itself as a critical infrastructure layer for product development in highly regulated industries, empowering life sciences companies to bring safer, innovative products to market more efficiently.