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.
In the news
- Sanaitio is starting a PhD 🎉 The Région wallonne (SPW Recherche) has awarded us a Win4Doc grant to conduct the CiValAI project, a four-year doctoral project run with the IREC UCLouvain-MIRO lab at Université catholique de Louvain and the HuMaLearn lab at Université de Namur. Dr. Ana Maria Barragan Montero and Pr. Benoît Frénay will be the academic supervisors. The question behind it: why do approved AI medical devices almost never reach daily clinical practice? More than 1,000 have been cleared. Hardly any are in routine
- We are excited to have Sophie Guillaume on board !
Related profiles
Something wrong or missing? Send an update. Fixed within 24 hours.