Most of what we build — AI Governor, Caliper, Discovery — is software, not a medical device. It doesn't need FDA clearance to run in your hospital, lab, or classroom. One thing we build — the ICH triage model — is a device, and it follows the device path. Below is exactly which is which, and how long each actually takes.
Short call: what you want tested and what "good evidence" needs to look like for your team.
Runs under your institution's existing research-use or IRB framework. No purchase order, no vendor risk review.
Every finding comes back signed and independently verifiable — you're not asked to take our word for it.
Publish it, extend the pilot, or convert to a license (Track 2). No obligation at any point.
AI Governor, Caliper, or Discovery — standalone or together.
Hosted by us, deployed in your environment, or air-gapped — whatever your compliance team requires.
REST API and a signed public verification endpoint from day one.
No IRB, no device review — procurement and IT security review, same as any enterprise software.
Your radiology/ED team runs the locked model against real cases under an IRB protocol.
Predicate-device comparison and validation data go to FDA. Timeline is set by FDA review, not by us.
Only after clearance does the ICH model deploy as a cleared diagnostic device.
One short conversation is enough to place you on the right track — most of the time it's obvious within the first five minutes.