SI
SI
discoversearch

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor.  We ask that you disable ad blocking while on Silicon Investor in the best interests of our community.  If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.
Strategies & Market Trends : Beat The Street With SI Traders

 Public ReplyPrvt ReplyMark as Last ReadFilePrevious 10Next 10PreviousNext  
From: Rocket Red9/27/2013 11:50:46 AM
  Read Replies (1) of 233806
 
U.S. approves first artificial pancreas system for diabetics
11:41 EDT Friday, September 27, 2013


Sept 27 (Reuters) - The U.S. Food and Drug Administration has approved the first artificial pancreas system for diabetics that reads blood sugar levels and automatically shuts off the flow of insulin.

The device, made by Medtronic Inc, could help the 3 million Americans living with type 1 diabetes better manage their disease, which causes the immune system to destroy cells in the pancreas that make insulin.

Patients suffering from type 1 diabetes, the inherited version of the disease, have to regularly monitor their blood sugar levels and take insulin several times a day.

Too little or too much of insulin can lead to several health problems, ranging from kidney failure and heart disease to brain damage.

The device includes an insulin pump and a glucose sensor that stops insulin delivery when blood glucose reaches a preset level.

The system has been approved for use by diabetics aged 16 years and older. Medtronic said it would conduct a post-approval study that would include children aged 2 years and older.

The Minneapolis, Minnesota-based company said it would begin ramping up production immediately to prepare for a launch in the next few weeks.

The company will also directly follow up with patients and make certain manufacturing changes according to the requirements of the approval and an accompanying warning letter it was issued on Sept. 19.

Medtronic said it has already addressed many of the observations in the warning letter and was committed to resolving the remaining issues as quickly as possible.
Report TOU ViolationShare This Post
 Public ReplyPrvt ReplyMark as Last ReadFilePrevious 10Next 10PreviousNext