Biocorp, a French company specializing in the development and manufacturing of medical devices and smart drug delivery systems announced that its smart sensor, Mallya has obtained the CE 0459 mark as medical device class IIb.
Mallya is a smart sensor that turns conventional insulin pens into connected devices.
Mallya records the key treatment information (selected dose, date and time of injection) and sends it to a dedicated mobile application.
The app also 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 perfectly with new usages of patients using Continuous Glucose Monitoring Systems or Connected Blood glucose systems.
Mallya is the only device available in its category to be labeled CE medical device, class IIb.
Mallya will be rolled out this fall, supported byBiocorp commercial partners.
- Biocorp. (2019, June 12). BIOCORP Announces The CE IIb Approval of Its Mallya Device. Retrieved June 13, 2019, from https://www.businesswire.com/news/home/20190612005727/en