Medtronic Inc. MDT +0.11%said the U.S. Food and Drug Administration has approved a pump designed to automatically stop insulin delivery in diabetes patients when blood-sugar levels are too low, the first "artificial pancreas" to be approved in the U.S.
Insulin works to lower blood sugar, but it can also cause sugar levels to fall too low. The condition, called hypoglycemia, can be fatal, especially at night when patients aren't aware their blood sugar is low. Medtronic's MiniMed 530G, which includes a sensor, sends out an alert if levels are too low, and if the individual is sleeping, unconscious or unable to react, the pump will shut off for two hours.
Blood-sugar sensors have been available to help diabetics program pumps to deliver the proper amount of insulin. Researchers have been working for years to link the two technologies to automate insulin delivery as part of an effort often referred to as an artificial pancreas.
Medtronic said its system is the first in the U.S. that can automatically stop insulin delivery when blood-sugar levels fall too low. A similar system is already approved for use in Europe.The company also said it can help people better control their diabetes versus the use of multiple injections.
The MiniMed has been approved for use by people with diabetes over the age of 16, though post-approval study will include children ages 2 and older. The company said it would begin ramping up production immediately to prepare for a MiniMed launch in the next several weeks.
The approval comes a week after Medtronic received an FDA warning letter about issues related to manufacturing processes, among other things, following an inspection of Medtronic's diabetes facility in Northridge, Calif. The company said it has already addressed many of the observations noted in the letter and will resolve the other concerns as quickly as possible.
Medtronic's MiniMed 530G is a new innovation that the FDA approved it. This devise is pump designed to automatically stop insulin delivery in diabetes patients when blood-sugar levels are too low. It has been approved for use by people with diabetes over the age of 16, though post-approval study will include children ages 2 and older.
There is a high percentage around the world people with diabetes. This devise will be the best choice for them to manage their shots of Insulin. This company should start get patent around the world. On the other hand, it's easy to copy this tech and produce it out the US.
This kind of devises usually in the beginning has high price, but with time the price will decrease. Poor people will buy the ungenuine.