FDA Clears Abbott’s FreeStyle Precision Pro Blood Glucose and β–Ketone Monitoring System™

Abbott has announced that it has received U.S. FDA clearance for its FreeStyle Precision Pro Blood Glucose and β-Ketone Monitoring System™, which it describes as an advanced blood glucose monitoring system designed to address the key needs of hospital customers.

Background

Abbott’s FreeStyle Precision Pro system allows for real-time, dual-band wireless communication between the handheld meter at the patient bedside and the hospital information system, giving clinical staff immediate access to patient test results throughout their facility. The dual-band wireless technology enables the flexibility of wireless access within a hospital’s Wi-Fi-enabled network when properly configured.

One advantage of the system is that clinical operators need not interrupt their busy workflow to conduct routine docking or attach a data cable to download patient results, saving time while also providing access to real-time data. This helps ensure immediate access to test results through the hospital’s electronic medical record system, and to facilitate clinical decision whenever it is needed.

Abbott says Freestyle is the only inpatient blood glucose monitoring system among leading hospital brands to use individually foil-wrapped test strips, helping reduce the risk of test strip cross-contamination of blood and bacteria. Abbott believes exclusive advantage helps hospitals comply with the Centers for Disease Control and Prevention regarding protection of unused supplies.

The device conforms to FDA requirements for cleaning and disinfection, which require devices to be disinfected after each use. The FreeStyle Precision Pro Meter also offers a replaceable strip port that can be removed for replacement on-site.

Company comments

“The FreeStyle Precision Pro system represents a significant step forward as we work to provide tools to improve the way hospitals manage patients’ glucose levels,” said Heather L. Mason, senior vice president, Diabetes Care, Abbott. “It makes the data available in real time, thanks to the meter’s new wireless capabilities. With its individually foil-wrapped test strips, the system is also designed to help reduce test strip cross-contamination in hospital environments.”

Source: Abbott Diabetes Care