Huma Granted Class II Clearance By FDA For Its Disease-Agnostic Platform

Huma has captured a “holy grail” of digital health; it now has an FDA-cleared tool that can not only collect data but also make recommendations based on it. 

On 12 June, the company announced that it has received class II clearance from the US Food and Drug Administration for its disease-agnostic, patient monitoring software as a medical device platform, making it the first on the market to receive both US and EU approval for that indication. The announcement comes just a few months after the company achieved a similar clearance in the European Union