Sam Brusco, Associate Editor12.08.22
BIOCORP has gained U.S. Food and Drug Administration (FDA) 510(k) clearance for its Mallya smart medical device that connects insulin pens.
The Mallya smart sensor is directly attached to insulin pens injectors to make them connected devices. It automatically collects and records selected insulin units and date/time of injection, then transmits the data to a dedicated digital application.
According to the company, it’s the first system approved in the U.S. capable of connecting different insulin and GLP-1 drugs. The initial version of Mallya is compatible with Sanofi’s Solostar pen injectors.
Eric Dessertenne, CEO of BIOCORP, told the press, "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.”
The company has signed major partnerships with diabetes leaders Novo Nordisk, Sanofi, and Roche Diabetes Care.
The Mallya smart sensor is directly attached to insulin pens injectors to make them connected devices. It automatically collects and records selected insulin units and date/time of injection, then transmits the data to a dedicated digital application.
According to the company, it’s the first system approved in the U.S. capable of connecting different insulin and GLP-1 drugs. The initial version of Mallya is compatible with Sanofi’s Solostar pen injectors.
Eric Dessertenne, CEO of BIOCORP, told the press, "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.”
The company has signed major partnerships with diabetes leaders Novo Nordisk, Sanofi, and Roche Diabetes Care.