|The G4 Platinum CGM--Courtesy of Dexcom|
As med tech outfits race to develop innovative, noninvasive technology for diabetes monitoring, Dexcom ($DXCM) snagged FDA approval for a new artificial pancreas algorithm for its continuous glucose monitoring (CGM) device.
The San Diego, CA-based company got a regulatory OK for Software 505, advanced technology that improves the accuracy and performance of its Dexcom G4 Platinum product for blood glucose monitoring. Patients can go online and download the software, or receive it preloaded into their receiver with new orders, the company said in a statement.
"This latest software enhancement to the Dexcom G4 Platinum will make the performance level comparable to episodic blood glucose finger sticks; this is a significant step in the evolution of CGM becoming the standard-of-care over blood glucose meters for people with diabetes," CEO Terrence Gregg said in a statement.
The regulatory blessing comes on the heels of more good news for Dexcom, as the company in October won FDA approval for its next-generation mobile communications device for diabetes monitoring. Dexcom Share, an add-on to its Dexcom G4 Platinum CGM, wirelessly transmits patients' glucose levels through a smartphone, and allows users to track information through an Apple device, iPhone or iPod touch. In February, Dexcom chalked up another regulatory win when the FDA greenlighted a pediatric version of the company's G4 Platinum device, making the company one of the first to offer a continuous glucose monitor for children.
FDA approval also helps Dexcom compete with other med tech outfits developing blood glucose monitoring devices. In January, Johnson & Johnson's ($JNJ) Animas division launched a new combination insulin pump and continuous glucose monitoring device in Canada, incorporating Dexcom's G4 sensor technology to track changes in glucose levels on a high-contrast, color-coded screen. In September, Abbott Laboratories ($ABT) grabbed a CE mark for its FreeStyle Libre Flash glucose monitoring system, a device that uses small sensors on the back of the arm to detect glucose levels and eliminates the needs for twice-daily finger-sticks to measure blood glucose.
Not to be outdone, med tech giant Medtronic ($MDT) is also hard at work on a noninvasive blood glucose monitoring product. In October, the Minneapolis-based company enrolled the first patients in a pivotal trial of its integrated insulin pump and CGM system. The device includes a new pump design and a sensor that is 80% smaller than the Enlite sensor currently available on the U.S. market, Medtronic said in a statement.
- read Dexcom's statement