Insulin pump system cleared for marketing

The alternate-controller-enabled (ACE) pump delivers insulin under the skin, either as a stand-alone or with other devices.

On July 25, the FDA cleared the Deka ACE Pump System for marketing. The prescription-only device is an alternate-controller-enabled (ACE) pump that delivers insulin under the skin and can be used as a stand-alone insulin pump or along with other diabetes devices that are also designed to be integrated into a customizable diabetes management system for automated insulin delivery.

This authorization paves the way for greater flexibility and patient choice for ACE pumps that can be used with an interoperable automated glycemic controller to form an automated insulin dosing system, the FDA said in an announcement of the clearance.