UK-based Huma is the world’s first company to receive class IIb certification under the EU Medical Device Regulation for a disease agnostic Software as a Medical Device (SaMD) platform, it announced on 23 March. This certification means that the product can now be configured for use in any patient and for the management of any condition.
The monitoring platform, which was previously certified for use in the EU as a class I device in 2018 and used in a much more limited capacity, can be used...