FDA clears Glucowatch for use in children:
This article was originally published in Clinica
Executive Summary
The US FDA has given Cygnus clearance to expand the market for it Glucowatch G2 Biographer to include its use in Type I diabetic children and adolescents aged 7 to 17 years. The FDA's decision was based on a 66-patient study that showed the device to be safe and effective in this patient popoulation. More than 150,000 children in the US suffer from diabetes, notes Cygnus, which says that its wristwatch-like Glucowatch monitor can provide up to six painless glucose measurements per hour for 13 hours. The device was FDA-approved in March this year for use in adults, says the Redwood City, California firm.