Building the Infrastructure for Regulated AI: Announcing Ketryx's $39M Series B

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The life sciences industry faces a fundamental problem that puts patient lives at risk: while unregulated tech companies ship AI-powered features hourly, life sciences teams release products yearly. The heavy burden of generating compliance paperwork required by regulatory bodies like the FDA delays the most innovative medical products from reaching patients. 

Both innovators and patients suffer when there are only two alternatives: move fast OR move safely. Ketryx eliminates this tradeoff. In an era where compliance complexity is rising and AI is transforming product development, our approach empowers teams to ship products faster and more safely than ever before. 

Just 18 months after our Series A led by Lightspeed Ventures, three of the world's top five MedTech companies trust Ketryx to power their most advanced AI-driven products. By enabling zero-lag compliance where traceability and documentation are generated automatically in real time, Ketryx allows regulated industries to move at the speed of innovation. 

Today, I'm excited to share that we've raised $39 million in Series B funding, led by Transformation Capital. Vinay Shah, Partner and founding team member, will join the Ketryx board. This brings our total funding to over $55 million, with participation from our existing investors: Lightspeed Venture Partners, MIT's E14 Fund, Ubiquity Ventures, and 53 Stations.

“In Medtech, long-term success depends on balancing innovation with the uncompromising demands of safety and compliance,” said Bill Hawkins, former CEO of Medtronic and new Ketryx investor. “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 products.”

The compliance tax on innovation

AI is entering medical devices at an unprecedented rate. Ambient note-takers, AI-driven diagnostics, robotic surgery platforms, and other AI applications in healthcare are already demonstrating improved patient outcomes. 

But with increased AI capability comes exponentially increasing documentation requirements (thousands of pages for every release) under lifecycle standards like IEC 62304. Documentation was a big problem a decade ago when, as the Head of AI for Amgen’s device group, I watched brilliant teams get bogged down in manual compliance and scattered validation processes. Engineers spent weeks referencing quality procedures instead of building features for patients.

Furthermore, with AI, regulators demand more rigor, not less—and rightly so. With increased complexity comes increased risk. The stakes are high as patient lives are on the line. And common tools like Jira, Git, and CI/CD tools aren’t compatible with the medical device industry’s traditional document-centric approach.  

This documentation and validation burden is the “compliance tax”: the hidden cost regulated industries pay in time, resources, and velocity just to meet regulatory requirements. Teams tell us that manually generating documentation consumes 50-80% of enterprise product development time.

As I wrote in this STAT article, it isn’t the regulation itself that’s the problem; it’s outdated compliance practices and tools. We started Ketryx to change that. Unlike traditional compliance tools, Ketryx was designed from the ground up for the AI-native, continuously deployed, cloud-connected reality of modern medical devices. And, I’m proud to say that in 2024—Ketryx’s first full year on the market—2% of all FDA approvals for AI/ML-enabled medical devices were built on Ketryx.

From Series A vision to Series B scale

When we raised our Series A, we set out to build the infrastructure for regulated AI so teams could innovate and release high-quality software at the speed of unregulated industries.

Today, Fortune 500 life sciences companies use Ketryx to develop and ship regulated AI. It’s the foundation for products that touch over 25 million patients annually. In an industry where many companies release new products or updates every two years, our customers ship every one to two weeks. 

Beyond the platform itself, Ketryx provides a complete end-to-end solution for regulated teams. Our team is made up of leaders from regulated sectors—healthcare, defense, aerospace, pharma, and MedTech—alongside the regulators who authored global standards for critical software compliance. Customers tell us that when they partner with Ketryx, they receive both a platform and the expertise to release regulated products at scale. 

With Series B, we’ll scale globally to meet growing demand—with a near-term goal of serving 100 million patients by 2030. 

Industry leaders trust Ketryx

Our AI-native platform automates the documentation, traceability, and validation workflows that traditionally bottleneck product development. Instead of completing documents manually at the end of the development cycle, teams generate real-time evidence automatically—so documents are ready when the code is complete. 

Here are a few examples of what teams have achieved with Ketryx:

• Nutrino - Medtronic reduced SBOM documentation time by 90% 
• Beacon Biosignals achieved industry-leading two-week release cycles, two 510(k) approvals, and two FDA-approved PCCPs 
• Radnet/DeepHealth deployed four FDA-approved AI-powered diagnostic products, serving 1.3M+ AI diagnoses per year
• Heartflow reduced complexity by 90% through implementing a system of systems architecture, serving over 400,000 patients

“Ketryx supports our system of systems architecture really easily out of the box. We were able to migrate our monolithic ecosystem into a single project and break it down into a desired state within just a couple of days. Ketryx delivered that because it was designed to scale. That was a huge plus.” Emre Gültürk, VP of Regulatory Affairs and Quality Systems, Heartflow

Scaling the future of regulated development

The life sciences industry—and every safety-critical field—stands at a transformative inflection point. Teams see AI's enormous potential but remain trapped by legacy compliance systems and paralyzing risk concerns.

It crushes me to see life-saving innovations get delayed by outdated processes. I'm convinced that safe AI adoption requires a fundamental change in how we build safety-critical products.

With this funding, we’re doubling down on: 

1. Accelerating product roadmap and AI agent development. We're expanding our AI Agent capabilities, and creating new automation that eliminates even more manual compliance work.
2. Building more integrations with best-in-class tooling. We're expanding and deepening integrations with the tools and workflows your teams already use.
3. Supporting global enterprise expansion. We're growing our enterprise customer success presence across the US and Europe and hiring world-class engineers, quality experts, and AI innovators in both Boston and Vienna. If you're passionate about building the software that makes life-saving products possible, let's talk.

The future we envision is one where safety and innovation go hand in hand. 

• Teams achieve zero-lag compliance
• Life sciences teams ship AI-powered features as fast as unregulated companies
• The safest products in the world are also the fastest to improve
• Products reach patients months or years faster 

Our Series B moves us significantly closer to helping achieve that future. 

To our customers: thank you for trusting us with your most critical infrastructure.

To our team in Boston and Vienna: this is just the start. We're building something that will fundamentally change how regulated products are made.

And to the patients whose lives are impacted by products built on Ketryx: this work is for you.