GI Dynamics, Inc. has announced that it has received conditional approval from the U.S. FDA to commence what it’s calling a pivotal clinical trial of the EndoBarrier® for the treatment of patients who have uncontrolled type 2 diabetes and are obese.
Data released on six month randomised, multi-centre trial of EndoBarrier® versus control in obese, type 2 diabetic subjects suggests the device, as well as being well tolerated does result in statistically significant reduced blood sugar levels and weight loss.
A little over four months after gaining FDA clearance Sanofi’s Glucose meter, which interfaces with an iPhone, is now commercially available through selected stores in the US. It’s been available for a while in most of Europe.
Echo Therapeutics is trumpeting clinical results from its transdermal glucose monitoring system which has been performed at Tufts Medical Center, Boston Mass. The study concerns use in an intensive care setting and the investigating clinicians seem impressed.
The device fans among us are always sad to see technology companies failing to thrive and no less so this time as what looks like a promising concept in Insulin pump design isn’t enough to stave off restructuring efforts.
Transdermal glucose monitoring future style, as well as potential for drug delivery from this new technology.
D.Medical has achieved CE mark status for its Spring™ Zone Insulin Delivery System featuring technology which is claimed to offer superior blockage and detachment detection in a device which is small, light, quiet and durable.
US non-surgical obesity solutions company GI Dynamics, Inc. today announced that it has designated two new Centres of Excellence in Germany, bringing to three the number of specialist units offering the Endobarrier treatment in the country.
Sanofi’s iBGStar™ , already available in Germany, France, Switzerland, the Netherlands and Italy has now gained FDA 510(k) premarket clearance in USA.