Biocorp Production announced that they have received 510(K) clearance from the U.S. Food & Drug Administration to market Mallya, its smart medical device that connects insulin pens. The Mallya medical device is a 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 compatible with SANOFI's Solostar pen injectors. Mallya is already the only device in its class to be CE marked as a Class IIb medical device. It offers the possibility to connect to different types of injection pens and thus to follow a patient in a multitherapy notably with a use of basal and rapid insulin.

BIOCORP has already signed major partnerships in the field with leaders of the diabetes space such as NOVO NORDISK, SANOFI AND ROCHE Diabetes Care. BIOCORP's 510K approval will accelerate the submission of Mallya's future generations in the diabetes field and in other therapeutic areas where the company has signed partnerships.