How Flo Health Built FDA-Ready Infrastructure Without Slowing Innovation

This article originally appeared in Femtech Insider on December 11, 2025.‍

With 420 million downloads and a user base that represents one in five women aged 18-35 in markets like the UK and US, Flo Health faced a critical challenge: How to evolve from a wellness app to a regulated medical device without sacrificing speed.

Their answer? Build regulatory compliance into the fabric of development rather than bolting it on top.

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