The US Food and Drug Administration (FDA) has granted clearance for US-based Nipro Diagnostics' True Metrix self-monitoring blood glucose system and the True Metrix PRO professional monitoring blood glucose system.
FDA clearance was based on the clinical trial, which evaluated the systems' accuracy when tested by lay users and healthcare professionals respectively.
Both systems feature Triple Sense Technology, which helps detect, analyse and correct for environmental and physiological variability, including hematocrit and temperature, results in providing accuracy.
The meter, a complex algorithm, test strip chemistry and electrodes work in line with True Metrix system to produce accurate results, and they feature pre and post-meal tags that allow patients to know about blood glucose results to better see how food affects blood glucose.
The products allow patients to tie notable events such as exercise, medication, and sickness, as well as blood glucose readings to determine patterns and trends.
Nipro Diagnostics CEO and president Scott Verner said: "With this investment, Nipro Diagnostics is building on its more than 25-year heritage of manufacturing blood glucose test strips in the United States.
"As we invest further in the US, this expansion will help us meet an ever-growing demand for blood glucose test strips as the number of people with diabetes is expected to continue to increase.
"Six consecutive years of Nipro Diagnostics' double-digit test strip growth has brought the need for sizeable manufacturing expansion, as demand for quality/value healthcare solutions continues to grow."
The company has also announced the expansion of the manufacturing capabilities at its Florida facility, where it carries out research and development, engineering and test strip manufacturing for all of the True branded blood glucose products.
"The launch of True Metrix and True Metrix PRO strengthen Nipro Diagnostics' leadership position in blood glucose monitoring and join a quickly expanding ecosystem of high-quality, high-value healthcare management products including nutritional, OTC healthcare and dietary supplements specifically designed to meet the health and wellness needs of the diabetes patient population," Verner added.
Under partner brands or Nipro Diagnostics' own True brand of products, True Metrix will be sold through retail, mail and distribution channels from fourth quarter of this year.
Image: True Metrix self-monitoring blood glucose meter. Photo: courtesy of Business Wire.