Biocorp’s Insulin Pen Sensor Gains 510(k) Clearance

The FDA has granted 510(k) clearance to Biocorp’s Mallya, a smart sensor that attaches to insulin pen injectors, making them connected devices.

The device records insulin units along with the date and time of injection then transmits the data to a digital application.

Mallya is currently compatible with Sanofi’s Solostar pen injectors, but Biocorp plans to make the device compatible with other pen injectors. The smart sensor has also gained CE mark certification.