BIOCORP secures FDA 510(k) approval for Mallya smart device

2022-12-08

上市批准

Mallya is a smart sensor that converts insulin pen injectors into connected medical devices, to automatically record important treatment information, and transfer the data to a dedicated mobile application Mallya turns insulin pens into connected devices. (Credit: Peter Stanic from Pixabay) French medical devices company BIOCORP has received the US Food & Drug Administration (FDA) 510(K) approval for its Mallya smart medical device for diabetes care. Mallya is a smart sensor designed to be directly attached to the insulin pen injectors, to convert them into connected medical devices. The smart sensor automatically records important treatment information, including insulin units selected, date, and time of injection, and transfers the data to a mobile app. Mallya is said to be the first device to be approved in the US, capable of automatically connecting different types of insulin and GLP-1 drugs. Also, it is the only device in its class to receive CE mark approval as a Class IIb medical device, said the company. BIOCORP CEO Eric Dessertenne said: “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 United States and illustrates BIOCORP’s ability to meet the highest regulatory requirements. “This news has been eagerly awaited by all our industry partners to commercialize Mallya in the world’s largest diabetes market and we are delighted that U.S. 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.” BIOCORP said that Mallya has the potential to connect different types of injection pens and follow up with a patient in a multi-therapy with the use of basal and rapid insulin. The initial version of Mallya is compatible with SANOFI’s Solostar pen injectors. The company has already partnered with major players in the field of diabetes care, including Merck, Sanofi, and Roche Diabetes Care. Earlier this year, BIOCORP signed a partnership agreement with Danish healthcare company Novo Nordisk to commercialise Mallya smart sensor in Japan. The FDA approval will support the submission of next-generation Mallya products in the diabetes field and in other therapeutic areas, said BIOCORP.

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