Advancing Digital Health: Huma SaMD Platform Gains U.S. Clearance

This week Huma Therapeutics received 510(k) clearance for its configurable Software as a Medical Device (SaMD) disease management platform, which previously received Class IIb approval in the EU. The FDA Class II clearance allows users to add AI algorithms to the disease-agnostic…

Source: www.medtechintelligence.com – Read more