Biocorp announced today that it received FDA 510(k) clearance to market its Mallya smart medical device that connects insulin pens.
Mallya, a smart sensor, attaches directly to insulin pen injectors to make them connected devices. It automatically collects nad records key treatment information and transmits it to a dedicated digital application. That data includes selected insulin units, date and time of injection.
Biocorp said in a news release that clearance makes Mallya the first system approved in the U.S. capable of automatically connecting different types of insulin and GLP-1 drugs. This includes an initial version of Mallya compatible with Sanofi’s Solostar pen injectors.
Mallya holds CE mark approval in Europe as a Class IIb medical device. It offers the ability to connect to different types of injection pens. It can allow patients to achieve multitherapy, notably with the use of basal and rapid insulin.
The company noted that FDA clearance helps it accelerate the submission of Mallya’s future generations. That includes the diabetes field and other therapeutic areas.
“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,” said Biocorp CEO Eric Dessertenne. “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.”