BIOCORP has announced that they have received 510(K) clearance from the U.S. Food & Drug Administration (FDA) to market Mallya, its smart sensor that is directly attached to insulin pen injectors, making them connected devices.
Mallya automatically collects and records key treatment information (selected insulin units, date, and time of injection) and transmits it to a dedicated digital application. Mallya becomes the first system approved in the U.S. capable of automatically connecting different types of insulin & GLP-1 drugs, with an initial version of Mallya being compatible with SANOFI’s Solostar pen injectors.
BIOCORP has already signed major partnerships in the field with leaders of the diabetes space such as Novo Nordisk, Sanofi and Roche Diabetes Care.
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