510(k) for Disetronic's insulin pump:
This article was originally published in Clinica
Executive Summary
Disetronic has received 510(k) clearance from the US FDA to market its Dahedi 25 insulin pump. The US subsidiary of the Swiss company claims its product is the smallest insulin pump available in the US. It is two-thirds the size of standard insulin pumps and weighs 20% less. It is already on sale in Germany and the Netherlands.