The FDA blocked Roche from selling the pumps in the US shortly after the company bought Desetronic Medical Systems, which specialized in insulin pumps. Roche bought the company in order to round out its diabetes care division, which provides blood glucose monitoring and insulin delivery systems. However, the agency believed that the production facilities were not meeting US standards.
After passing an inspection last year at the manufacturing site in Burgdorf, Switzerland, Roche is now ready to launch the technology in the US market. The diabetes self-management system includes an insulin pump, a blood glucose monitor, and software with a bolus calculator and is already used in 30 countries.
Sarah Hanssen, vice president and general manager of Disetronic Medical Systems, said: “This is a milestone for our Diabetes Care business unit and for our customers. It confirms our ongoing commitment to providing people with state-of-the-art insulin pump therapy products, and help them better manage their diabetes.”