Diabetes company Nipro Diagnostics touted FDA wins for a pair of new blood glucose monitors for use in home and professional settings, saying that the device maker will look to boost its manufacturing capabilities ahead of a late 2014 launch.
Nipro won FDA clearance for its True Metrix self-monitoring system as well as the True Metrix Pro professional blood glucose monitor, the company said today. The products will be available through retail, mail and distribution channels, either under Nipro’s own brand or through partner brands, starting in Q4 this year.
The company acquired "significant capital investment" ahead of its latest FDA wins, and some of that funding will go toward major expansions at Nipro’s Fort Lauderdale, Fla., facility.
"As we invest further in the U.S., 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," president & CEO Scott Verner said in prepared remarks. "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 new True Metrix devices host a number of sophisticated features, including Nipro’s proprietary "Triple Sense Technology" that attempts to detect and correct for environmental and physiological factors, such as temperature and hematocrit. The meters also let users tag pre- or post-meal readings and note exercise, medication, general wellness and other factors that may help identify trends in blood glucose levels.
The FDA clearances are good news for the device maker, which issued a voluntary recall early this year after shipping about 600 of its TRUEbalance and TRUEtrack blood glucose meters with the incorrect default unit of measure.