Published on 23 August 2023

The Accu-Chek Solo micropump system received 510(k) clearance

Roche announced today that it has obtained the 510(k) clearance for the Accu-Chek Solo® micropump system from the U.S. Food and Drug Administration (FDA). This marks a substantial milestone in continuous subcutaneous insulin infusion therapy (CSII) for people living with diabetes given the clinical significance of insulin pumps in daily diabetes management. 

“We are pleased to see our latest innovative pump system cleared by the FDA”, says Marcel Gmünder, Global Head of Roche Diabetes Care. “We are proud of our teams who have been steadfast in their activities to accomplish this important achievement for our Accu-Chek Solo system and appreciate the close collaboration with the authority.”

With the Accu-Chek Solo micropump system, Roche Diabetes Care aims to address the evolving needs of people living with diabetes worldwide and empower them to confidently steer their insulin pump therapy and live healthier, more fulfilling lives. This is consistent with the company’s commitment to providing leading integrated Personalised Diabetes Management solutions. 

“Our vision is to simplify everyday treatment for people with diabetes all over the world so their condition becomes less of a constant burden,” Marcel Gmünder explains. “Life should be made easier for people with diabetes and their  caregivers to support better outcomes and bring true relief.” 

An update on the next steps for further developments and timelines for launch will be provided in due course.


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