# How Flo Health Built FDA-Ready Infrastructure Without Slowing Innovation

Femtech Insider

and

Femtech Insider

December 11, 2025

[Medtech](https://www.ketryx.com/learn/blog?tag=medtech)

## Table of Contents

[Section link](https://www.ketryx.com/blog/how-flo-health-built-fda-ready-infrastructure-without-slowing-innovation#)

[_This article originally appeared in Femtech Insider on December 11, 2025._](https://femtechinsider.com/how-flo-health-built-fda-ready-infrastructure-without-slowing-innovation/) **‍**

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](https://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.

‍

[Read the full article](https://femtechinsider.com/how-flo-health-built-fda-ready-infrastructure-without-slowing-innovation/)

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