Sanaitio

TLDR

Sanaitio provides AI medical device consulting focused on regulatory navigation and clinical validation to bridge the gap between regulatory approval and clinical adoption.

Overview

Sanaitio helps medtech companies develop, validate, and deploy AI-based medical devices that earn clinical adoption and regulatory approval. The company addresses the adoption gap where most FDA-cleared AI devices lack clinical evidence and fail to reach routine use. Services include causal modelling, Bayesian validation, and regulatory navigation across MDR, AI Act, and FDA requirements.