>HUMA
>Class II level clearance permits Huma’s platform to host artificial intelligence algorithms that use automated data analytics to support screening, diagnosis, dosing recommendations, clinical decision making and prognostication.
>By harnessing this new functionality, healthcare providers can identify at risk patients, intervene early and deliver high quality care more effectively.
>Class II clearance further enables greater support for patients to drive self-management who display early signs and symptoms that may indicate disease progression and more serious and avoidable events.
>As part of the platform approval, Huma’s cardiovascular risk score algorithm, currently being rolled out as part of a nationwide screening programme in the US aimed at improving cardiovascular health, was also FDA 510-K cleared.
https://www.huma.com/resources/us-fda-510k-classii-regulatory-clearance-configurable-samd-disease-management