Accelerating the development of CGM sensors for FDA approvalAccelerating the development of CGM sensors for FDA approval

Progressing the development of a novel CGM sensor to the point where it can improve the quality of life for millions of people with diabetes can be a tall order. In order to build confidence that the sensor will be accurate enough to meet FDA requirements, even the in vitro testing calls for significant rigour. Testing needs to move beyond manual processes and basic lab setups, with hundreds or thousands of sensors producing vast amounts of data over an extended period. A single sensor can generate 100,000 data points weekly - requiring an automated, reliable and repeatable testing solution.