Ascensia Diabetes Care, a new business unit created this year when Panasonic Healthcare Holdings acquired Bayer Diabetes Care, has announced the launch and FDA 510(k) clearance of its Contour Next Link blood glucose monitor.
Ascensia makes a line of connected and non-connected fingerstick glucometers. The Contour Next Link is a version that sends data wirelessly to Medtronic's MiniMed 630G insulin pump. According to Ascensia, it's the only FDA-cleared glucometer that connects to that pump, a new Medtronic offering that also just launched today.
“We are delighted that the MiniMed 630G system with the Contour Next Link 2.4 Meter will now be available to people with diabetes in the United States,” Ascensia president Robert Schumm said in a statement. “The accuracy of our blood glucose monitoring system combined with the new innovative technology of the MiniMed 630G system will truly help people with diabetes manage their condition.”
A notable new feature of the 630G system is that it integrates with a continuous glucose monitor (CGM) and SmartGuard technology, which triggers an alarm when the CGM sensor glucose level reaches a preset low threshold and suspends insulin delivery automatically if the user is unresponsive to the alarm.
Automatically transmitting blood glucose readings from the Contour Next Link device helps reduce the possibility of input errors that can lead to miscalculated insulin dosing, and also allows those readings to be automatically used to calibrate the CGM. Users can also remotely trigger one dose of insulin from the meter.
Panasonic purchased Bayer's diabetes care for about $1.11 billion (1 billion euro) in January.
“We are excited to launch as Ascensia Diabetes Care and continue to be a trustworthy provider of reliable, high-performance solutions that could make a positive, daily difference for people with diabetes," Ascensia CEO Michael Kloss, said at the time. "This is a unique and exciting opportunity for us to expand our business and better serve our patients, customers and partners worldwide. Panasonic Healthcare has been a pioneer in the development of key diabetes care products, and we are thrilled to work together with them to introduce new and innovative technologies that enhance the lives of patients living with diabetes. We are focused on moving forward into an exciting future and continuing to play a leading role in the diabetes care industry.”