|The G4 Platinum CGM--Courtesy of DexCom|
Children as young as 2 years old can now use the latest in diabetes med tech, even as the company that developed it is in a race to surpass its most current technology. The FDA announced Monday it has approved a pediatric version of DexCom's ($DXCM) G4 Platinum. The San Diego med tech now has the first continuous glucose monitor (CGM) approved in the U.S. for toddlers.
The G4 Platinum is among a generation of slim, small CGMs that wirelessly report glucose levels every few minutes. The pediatric designation puts DexCom among the relatively few companies that have developed medical devices for children.
It's a market the FDA views as neglected. Last September, the regulatory agency flagged pediatric devices as a priority, setting aside $3.5 million for research and academic-industry partnerships in pediatric-friendly devices that address unmet needs.
DexCom isn't the only diabetes-focused company working on child-friendly devices. Its pediatric CGM could be peanut butter to Novo Nordisk's jelly. The Danish drugmaker ($NVO) is set to hit the U.S. market in early 2014 with its NovoPen Echo, a child-friendly insulin pen approved last August.
Meanwhile, the company is racing to get beyond glucose monitoring. Paired with J&J's ($JNJ) Animas unit, DexCom is vying with Medtronic ($MDT) and upstart Tandem to be first to develop the next generation of diabetes devices--a closed-loop insulin pump. Also known as an artificial pancreas, the devices would detect blood glucose content and respond automatically. It's a long-standing goal. If reached, it would be a major improvement over the current generation of CGMs.
- read DexCom's release
- here's the FDA's announcement