Biocorp S.A. (Paris:ALCOR), a French company specialising in the development and manufacturing of medical devices and smart drug delivery systems, on Wednesday announced that its Mallya device has obtained the CE 0459 mark as medical device class IIb.
Mallya is a smart sensor that turns conventional insulin pens into connected devices. It records the key treatment information (selected dose, date and time of injection) and sends it to a dedicated mobile application. Also, the app allows the patient user to view a summary report of doses injected over a period of time (up to 90 days).
This device allows an automatic recording of the doses injected with the highest accuracy, removing the need for manual logbooks. Mallya fits with new usages of patients using Continuous Glucose Monitoring Systems or Connected Blood glucose systems, the company added.
Reportedly, Mallya is currently the only device available in its category to be labelled CE medical device, class IIb.
Mallya is planned to be rolled out in autumn 2019, supported by Biocorp's commercial partners.
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