Biocorp, a French medical devices company focused on smart drug delivery systems, announced that its Mallya device has obtained the CE 0459 mark as medical device class IIb.
Biocorp said that its Mallya is a smart sensor that converts conventional insulin pens into connected devices.
Mallya records the key treatment information including selected dose, date and time of injection and sends it to a dedicated mobile application.
The mobile application allows the patient user to view a summary report of doses injected over a period of time (usually up to 90 days).
In addition, the device allows an automatic recording of the doses injected with the high accuracy, and eliminates the need of manual logbooks.
Mallya is a smart cap for pen injectors that captures injection data and automatically transmits data to a mobile app, helping patients to manage their treatment.
The company said that its Mallya device is compatible with new usages of continuous glucose monitoring systems or connected blood glucose systems by patients.
Biocorp claims that its Mallya marks the only device available in its category to be labeled CE medical device, class IIb.
The device is set to offer many benefits to patients and health professionals as it was designed based on a patented concept, and device was tested in several studies.
The ease of installation and use of the device would not disturb the use of the pen, and the reliability of information collected and transmitted to the mobile app, makes it more beneficial.
Biocorp said that it will roll out Mallya this fall, with support of its commercial partners.
Biocorp was founded in 2004 in Issoire, France, as a company specialized in development and manufacturing of medical devices and innovative drug delivery systems.
The company holds more than twenty years of experience and offers more than 30 manufactured products, to provide drug delivery solutions that meet the evolving needs of patients.
With a team of 45 employees, Biocorp claims to continue making innovations in medical plastics, its core business, and to market traditional devices.