Ketryx raises $39M to advance AI compliance in life sciences

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.