Ketryx, a rapidly growing AI-based compliance platform built for the life sciences industry, has announced the close of its $39 million Series B funding round. Led by Transformation Capital, the round also saw continued support from existing investors, including Lightspeed Venture Partners, MIT’s E14 Fund, Ubiquity Ventures, and 53 Stations.
This latest funding round brings Ketryx’s total to over $55 million. In connection with the funding, Vinay Shah, a founding team member and partner at Transformation Capital, was appointed to the company’s board of directors.
The funding arrives at a time when life sciences companies are under increasing pressure to innovate rapidly while adhering to stringent regulatory standards. The rise of AI and machine learning has opened up new possibilities for diagnostics, therapeutics, and digital health tools, but it has also introduced new layers of complexity. Teams are racing to integrate these technologies into regulated workflows, yet many are still relying on outdated infrastructure that wasn’t built for the pace or precision required in today’s environment.
Ketryx was created to address this exact tension. The platform is designed to help regulated organizations move faster without sacrificing safety or compliance. It automates critical aspects of the product development lifecycle, including validation, traceability, and documentation, all of which are aligned with FDA and EU MDR standards.
By embedding compliance directly into the development process, Ketryx enables teams to maintain regulatory rigor while dramatically reducing the time and effort required to bring new products to market.
The impact of this approach is already being felt across the industry. Customers have reported significant gains in efficiency, including up to a 90 percent reduction in documentation time and more than tenfold acceleration in release cycles. These improvements are not just operational—they’re strategic. In a field where delays can mean missed opportunities or compromised patient outcomes, speed and safety must go hand in hand.
Ketryx’s platform is built for enterprise-scale deployment and is already in use by three of the top five global medtech companies, as well as several Fortune 500 organizations. It’s also powering compliance for AI-driven health companies like DeepHealth, Heartflow, and Aignostics, which are pushing the boundaries of what’s possible in digital diagnostics and precision medicine.
As adoption continues to grow, Ketryx is emerging as a foundational layer of infrastructure for regulated product development—one that enables real-time traceability, continuous validation, and seamless documentation.
The Series B funding will allow Ketryx to expand its platform capabilities, grow its team, and deepen its partnerships across the life sciences ecosystem. The company plans to invest in product development to support increasingly complex regulatory environments and ensure its platform remains at the forefront as AI continues to transform the industry.
Ketryx’s momentum reflects a broader shift in how regulated industries are approaching innovation. Rather than viewing compliance as a bottleneck, companies are beginning to see it as a strategic advantage—especially when it’s powered by intelligent systems that can keep pace with rapid development cycles. By embedding compliance into the core of product development, Ketryx is helping life sciences organizations deliver safer, more effective solutions to market faster than ever before.
KEY QUOTES:
“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.”
“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.”
Erez Kaminski, CEO and founder of Ketryx
“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.”
Bill Hawkins, former CEO of Medtronic and new Ketryx investor
“Medtech teams are leading the way in applying artificial intelligence to improve patient outcomes, creating products that meet the highest safety and regulatory standards. 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.”
Vinay Shah, Partner and Founding Team Member at Transformation Capital
