French medical devices company BIOCORP has secured 510(k) clearance for marketing its Mallya smart medical device from the US Food and Drug Administration (FDA).
Mallya is a smart sensor that has been designed to be attached directly to insulin pen injectors, converting them into connected devices.
It automatically records important treatment information, including selected insulin units as well as the date and time of injection, and transmits the data to a dedicated digital app.
Mallya is claimed to be the first device capable of automatically connecting different insulin and GLP-1 drugs to be approved in the US.
It is also the only device in its class to receive CE mark as a Class IIb medical device.
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 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.”
The company stated that the new device can connect to different injection pen types, allowing patients in a multitherapy with basal and rapid insulin use to be followed.
It also noted that the initial version of Mallya is compatible with the Sanofi Solostar pen injectors.
The regulatory approval is expected to support the further submission of next-generation Mallya products in the diabetes field and other therapeutic areas.