The new guidance reshapes the predicate landscape for cuffless BP. We map your technology, claims, and clinical evidence against both pathways — and tell you which one your competitors will be forced into.
Recent case study
Existing EU data. Strategy designed to get to U.S. market with minimal extra effort.
We secured breakthrough status and drove a 3-month FDA submission for an AI breast-risk SaMD.
We isolated Neosoma's new CNN for FDA review, won clearance in 3 months, and built a framework for every product after.
Trusted by
Our FDA Clearances
Every great partnership starts with a conversation. Fill out the form below for a discovery call, and an Innolitics team member will contact you soon.
I learned more from an hour-long Innolitics sales call than an entire paid engagement from other consultants.
Richard Clark
Executive in Residence at Washington University
