CeQur SA received CE Mark approval to commercialize its PaQ insulin delivery devices in the European market, the company reported this week.
The PaQ insulin delivery system features a disposable insulin-infuser reservoir attached to a reusable insulin monitor and provides 3 days of continuous basal insulin delivery and on-demand bolus insulin for individuals with Type II diabetes, the company said.
"This regulatory achievement demonstrates the quality of both the PaQ device and the internal processes we’ve put in place to move this unique, important product through development and into the marketplace," founder & CEO James Peterson said in prepared remarks.
CeQur in June initiated a clinical study conducted with the University Hospital Graz, Austria, to evaluate if PaQ could replace insulin injections among people with Type II diabetes. The study showed glycemic control, patient satisfaction and safety, according to a press release.
