Huma Receives Multi-Condition U.S. FDA 510(k) Class II Regulatory Clearance For Its Configurable SaMD Disease Management

Huma Therapeutics (Huma), a leading global digital health company, has received U.S. Food and Drug Administration (FDA) Class II clearance for its disease-agnostic Software as a Medical Device (SaMD) disease management platform. This clearance marks a significant milestone in consumer monitoring and disease management.

Huma’s SaMD platform powers digital health pathways through which data are collected from consumers for self-management or to be assessed remotely by health care professionals (HCPs). Huma’s technologies include remote consumer monitoring systems and companion apps to enable disease management.

Achieving Class II clearance means the platform is permitted to monitor . . .