Pronia News and Press Releases
Pronia Medical Systems receives FDA 510(k) Clearance for the GlucoCare™ Intensive Glycemic Control System
LOUISVILLE, Kentucky - August 25, 2008 — Pronia Medical Systems, LLC announced today that it has received FDA 510(k) clearance for its GlucoCare™ Intensive Glycemic Control (IGC) System. The company obtained clearance for 2 versions of an intensive glycemic control protocol developed at Yale University with glucose targets of 90-120 mg/dl and 100-139 mg/dl. These protocols are the first of many that will be added to the GlucoCare system which is designed to incorporate any proven-safe insulin control algorithm. This maximizes flexibility in allowing for continuous addition of new protocols as the state of the science behind glucose control changes over time. Hospitals will be able to choose from a multitude of protocols specifically designed for a given patient population. No other automated decision support system for tight glycemic control like GlucoCare is currently available.