Voluntis Secures FDA Clearance and CE Mark for Digital Diabetes Management System

Voluntis announced last week that it received FDA clearance and CE Mark approval to integrate Insulia, its digital diabetes management system, with Sanofi’s Toujeo insulin glargine.

The company’s software already works with Levemir and Lantus. The system uses a patient mobile app and web portal to provide real time insulin dosage recommendations and informational messages.

Voluntis plans to launch the system in the European market in the near future. It is currently working on an extension for the app to include basal insulins and GLP-1 basal insulin combos.