Biocorp receives FDA 510(k) approval for Mallya device

pharmafile | December 8, 2022 | News story | Medical Communications  

French medical devices company, Biocorp, has received the FDA’s 510(k) approval for diabetes care device, Mallya. The device is a sensor which can be directly attached to insulin pen injectors, converting them to connected medical devices, and automatically recording key information including insulin units, and date and time of injection, saving this data in a connected mobile app.

Mallya is the first device of its kind to be approved in the US, and is the only device of its class to have received CE mark approval as a Class IIb medical device. It is capable of recording data about different types of insulin, as well as GLP-1 drugs.

Biocorp has said that the device has potential to work with different types of injector pens, although the initial version of Mallya is currently compatible with Sanofi’s Solostar pen injectors. Biocorp have also already signed a partnership agreement with Novo Nordisk for commercialisation of Mallya in Japan.

Eric Dessertenne, chief executive officer of Biocorn, commented: “This approval is a major achievement for Biocorp and all of our employees who have been heavily involved in this regulatory process. This approval marks a historic achievement for Biocorp as it allows the commercial launch of our Mallya device in the US and illustrates Biocorp’s ability to meet the highest regulatory requirements. This news has been eagerly awaited by all our industry partners to commercialise Mallya in the world’s largest diabetes market and we are delighted that US patients will soon be able to benefit from Mallya’s services. This regulatory milestone will have a positive impact on our sales outlook in 2023 and positions Biocorp as a leader in the field of smart pens.”


Betsy Goodfellow

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