Roche announced that the US Food and Drug Administration (FDA) has lifted the import alert for the sale of Accu-Chek insulin pumps by Disetronic Medical Systems AG (Burgdorf, Switzerland) for customers in the US, following the inspection of the Disetronic site last year.
"This is an important milestone for our Diabetes Care business unit and for all our employees who contributed to the achievement. It confirms our ongoing commitment to quality, regulatory and compliance programmes across the world. In addition, we appreciate the support from the agency throughout the assessment process," said Severin Schwan, CEO Division Roche Diagnostics and Member of Roche's corporate executive committee.
The lift of the import alert clears the path for an imminent launch of the Accu-Chek Spirit insulin pump system in the US. The insulin pump has been well received by consumers and healthcare professionals around the world. Currently, the Accu-Chek Spirit insulin pump is available in more than 30 countries. The FDA announcement is a further step toward worldwide access to the full insulin delivery portfolio of Roche.
Roche Diabetes Care is a pioneer in the development of blood glucose monitoring and insulin delivery systems as well as services to enable patient focused, cost effective, efficient diabetes management. For 30 years, the Accu-Chek brand has been committed to making life easier for people with diabetes and healthcare professionals and is completing the circle of care in diabetes management by offering blood glucose meters, insulin delivery systems and advice tools.