Ketryx, the AI-native compliance platform for safety-critical product development, today announced record momentum following a year in which the company surpassed serving 100 million patients and proved that safety-critical product development no longer has to be slow. As medical device, digital health, diagnostics, and life sciences organizations accelerate from AI experimentation to enterprise-wide deployment, four of the top five Fortune 500 MedTech companies now run on Ketryx.
Over the past year, Ketryx strengthened its market leadership with a $39M Series B, the launch of the industry’s first validated AI agents, and the signing of marquee customers, including Meta Reality Labs and Flo Health. The results are measurable: teams using Ketryx are shipping products weekly, with one Ketryx customer completing 170 medical device releases in a single year, a stat that used to be unheard of in an industry where two per year used to be considered fast.
“Ketryx is built for teams that cannot afford mistakes, but want to innovate fast,” said Erez Kaminski, founder and CEO of Ketryx. “In 2025, the industry crossed an inflection point. Regulated teams stopped asking whether AI was safe enough to use and started asking how to deploy it faster. We saw this play out with our customers: teams that once shipped products twice a year are now releasing multiple times a week, without sacrificing a single compliance requirement. AI is no longer optional in life sciences. It’s now how the best teams compete.”
Key 2025 milestones fueling Ketryx’s momentum include:
- Increasing Customer Adoption: Four of the top five Fortune 500 medical technology companies now rely on Ketryx, and the platform today supports products that reach more than 100 million patients worldwide. Ketryx added AI-native leaders, including Meta and Flo Health, alongside continued expansion with the world’s largest life science companies.
- Proven Customer Outcomes: Meta Reality Labs, one of the world’s most sophisticated engineering organizations, uses Ketryx to build its regulated medical device compliance foundation from the ground up, cutting compliance review cycles from weeks to minutes while preserving the full velocity of its AI development teams. Flo Health, the world’s largest women’s health platform, moved from an unregulated organization to a fully audit-ready, FDA-grade operation in under 90 days, with no reduction in engineering speed. Across the platform, Ketryx customers ship products weekly.
- Series B Funding to Scale Validated AI: Led by Transformation Capital, Ketryx raised $39M in a Series B round to accelerate product development, customer expansion, and global growth. The round included participation from Lightspeed Ventures and prominent MedTech executives Bill Watkins, former CEO of Medtronic, Travis May, Former CEO of Datavant, and Michal Preminger, former Head of Innovation at Johnson & Johnson.
- Launch of the First Validated AI Agents for Regulated Industries: The company introduced the first validated AI agents designed specifically for safety-critical product development, enabling teams to automate documentation, testing, and regulatory workflows while maintaining full auditability and compliance.
- Team and Leadership Growth: Ketryx appointed Mary Brook Delano as Chief Business Officer to accelerate go-to-market execution, added Tim Brodeur, formerly of Veeva and Benchling, to lead the company’s Success and Delivery function, and more than doubled employee headcount year over year.
- Accepted into NVIDIA’s Inception Program: Ketryx joins a special cohort of AI innovators recognized by NVIDIA, gaining access to advanced AI infrastructure, developer tools, and go-to-market support to accelerate the development of validated AI agents for life sciences.
- New Cambridge Headquarters: To accommodate its expanding team and increased customer engagement, Ketryx moved into a significantly larger office in Kendall Square. The new space is designed to support hiring, collaboration, and hands-on education for partners adopting validated AI in regulated environments.
Positioned for a Strong 2026
As regulatory scrutiny of AI systems continues to increase, Ketryx is entering 2026 with growing demand from companies seeking faster development cycles without compromising safety or compliance. Across life sciences, 2026 is shaping up to be the year AI moves from pilots into the core of R&D operations.
“As life sciences organizations operationalize AI across R&D, quality, and regulatory functions, the winners will be those that can move fast without breaking trust,” Kaminski added. “Speed and compliance used to be a tradeoff in regulated industries. Ketryx ends that tradeoff, and we’re excited for the inevitable innovation that will quickly follow.”
For more information, visit www.ketryx.com.
Ketryx transforms the product lifecycle of life science teams to deliver safer products, faster. Trusted by four of the world’s top five medical device manufacturers, its AI-native compliance platform overlays existing tools to automate documentation, create traceability, and accelerate release cycles—without disrupting existing workflows. Ketryx AI Agents cut manual work by 90 percent and close compliance gaps, elevating speed and quality across the entire product lifecycle. For more information, visit www.ketryx.com.