Huma receives US FDA Class II clearance for SaMD platform

Huma Therapeutics has received US Food and Drug Administration (FDA) Class II clearance for its disease-agnostic Software-as-a-Medical-Device (SaMD) platform, enabling companies to launch their own algorithm innovations more quickly to the platform and allowing AI algorithms for disease prognostication and recommendations for treatment.

Exclusive: Huma receives US FDA Class II clearance for SaMD platform (digitalhealth.net)