New Products In Brief

Debuts include DexCom’s G4 Platinum continuous glucose monitor, OraSure’s OraQuick in-home HIV test and St. Jude’s MediGuide 3D navigation system for cardiovascular procedures.

Continuous glucose monitoring device maker DexCom Inc. will begin shipping its fourth-generation G4 Platinum CGM system to patients within the next several days following receipt of PMA approval, the firm announced Oct. 8. The San Diego-based company calls the product the most-advanced CGM system available, due to its overall accuracy and ease of use. Clinical trial data demonstrated that the system is approximately 19% more accurate than the company’s Seven Plus CGM device and roughly 30% more accurate in the hypoglycemia range below 70 milligrams per deciliter, Dexcom says. “Improved accuracy in the critical hypoglycemic range is the most important from a life-saving point of view,” said DexCom CEO Terrance H. Gregg. “We believe G4 Platinum sets a new standard for performance, will create more positive initial experiences for patients and health care providers and will better meet patient expectations regarding continuous glucose monitoring,” he explained during an Oct. 8 conference call with analysts. And, “we believe [it] provides us the chance to meaningfully revisit the benefits of CGM with patients and health care providers who might have had a negative experience with other CGM systems in the past.”

The system consists of a sensor, a transmitter and a monitor. The sensor is about the diameter of a human hair and is inserted by the user under the skin...

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