Before the FDA's First AI Warning Letter, There Was Ketryx
Ubiquity backed Ketryx in 2021, 5 years before the FDA took action.
On April 2, 2026, the FDA issued its first warning letter citing a drug manufacturer’s overreliance on AI in regulated production. The core message landed far beyond that one company. AI-generated documentation must be reviewed and verified by qualified humans before submission. Overreliance on AI output is a violation of 21 CFR 211.22(c), federal manufacturing standards that carry serious regulatory consequences.
Most investors read that letter as a risk flag. Erez Kaminski, CEO of Ubiquity Ventures-backed Ketryx, had been building the solution to that exact problem since 2021.
Ubiquity co-led Ketryx’s pre-seed round in November 2021 with our friends at E14. At the time, “agentic AI for FDA compliance” was not a category that had a name, let alone a conference track. Understanding the opportunity required going into the innards of how life science software actually gets developed and approved:
The disconnected quality management tools built thirty years ago.
The manual documentation burden that compounds with every software change.
The near-impossibility of updating a cleared medical products without triggering a full regulatory review.
Most investors passed. The category was too niche, too technical, too far from anything that looked like momentum.
The key signal: a prepared mind meets opportunity
Erez came to this problem from a background that few founders bring to enterprise software. A physics graduate, a military veteran, a former AI lead at Amgen, the world’s largest biotech, he had watched firsthand how the gap between modern software development practices and FDA-mandated quality processes made it nearly impossible to move fast in regulated industries. His mother is both a physician and a cochlear implant patient. The problem was personal before it was a business:
“When I saw how people build FDA-regulated software, I suddenly understood why it is so hard to update medical devices.”
he wrote in a 2023 Ubiquity blog post.
“The tools they use were built 30+ years ago. Ketryx is unifying those worlds: the ability to build safe and reliable medical software but with all the advantages of modern tools.”
What Ketryx built is an agentic AI platform that sits inside the development workflow, tracks the decisions that matter for regulatory submissions, generates and maintains the documentation those submissions require, and keeps everything traceable end to end. The FDA warning letter from April 2026 did not create Ketryx’s market. It described it, officially, to every life sciences company in the country.
Erez made the same argument publicly. In an April 2026 post on the Ketryx blog, he read the warning letter as a design spec for compliant AI.
“For the first time, they have told the industry precisely how compliant AI needs to look,”
While most coverage urged life sciences teams to slow down their AI adoption, Erez argued the letter revealed exactly what architecture regulated AI requires, the same architecture Ketryx had been building since 2021.
Today Ketryx is the widest deployed AI solution for life science, trusted by 4 of the top 5 medical device companies and supports products reaching 100M patients globally.
Earlier this year they signed their first customer outside healthcare, in robotics, a signal that Ketryx’s underlying compliance platform applies anywhere software touches a regulated physical system.
This is what nerdy and early looks like in practice.
Not arriving after a category has a name, but understanding the underlying technical and regulatory mechanics well enough to move before the industry catches up.
The same pattern runs through the Ubiquity portfolio: Halter before agri-tech was a recognized investment category, Loft Orbital before commercial space infrastructure had a clear business model, BusRight before anyone was calling school transportation a software problem.
Ubiquity backs technical founders solving hard problems in sectors that do not look exciting until they suddenly do. If you are building in regulated software, or seeing deals in this space and want a second opinion from someone who has been living in it since 2021, reach out.
Ubiquity Ventures is a seed-stage venture capital firm investing in software beyond the screen. We back founders building AI, software, and smart hardware for the physical world — technology you can touch, hear, and feel.
If you know a founder working on something nerdy and early, we’d love an introduction.