Radisen builds AI for medical imaging. The mammography program develops software that assists radiologists in reading mammograms for breast-cancer screening — a regulated medical device, which means the model has to clear clinical validation and regulatory approval before it can be used on real patients.
That regulatory bar changes everything upstream: data provenance, label quality, and reproducibility matter as much as model accuracy. I joined this program on the operations and data side, working alongside the ML and clinical teams rather than developing the diagnostic model itself.
This was my first close look at how a regulated medical-AI product actually ships. The lesson that stuck: in high-stakes settings, the unglamorous data and process work — where the data came from, how it was labeled, whether it can be reproduced and defended to a regulator — is often what decides whether a model can be trusted at all.