Navigation Links
FDA Issues Draft Guidance for Early Version of an Artificial Pancreas System
Date:6/20/2011

SILVER SPRING, Md., June 20, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today issued draft guidance that will help advance the development and approval of an artificial pancreas system to treat type 1 diabetes in the United States.

(Logo:  http://photos.prnewswire.com/prnh/20090824/FDALOGO)

Type 1 diabetes is a chronic condition in which the pancreas produces little or no insulin, a hormone needed to properly control blood glucose (sugar) levels. Without enough insulin, glucose builds up in the bloodstream instead of going into the cells.

People with type 1 diabetes must regulate their blood glucose levels by checking their levels with a glucose meter multiple times daily, calculating how much insulin is needed to lower their blood glucose levels, and administering the necessary dose using a syringe or insulin pump.

An artificial pancreas system is an automated, closed-loop system that combines a continuous glucose monitor, an insulin infusion pump, and a glucose meter for calibrating the monitor. The devices are designed to work together, monitoring the body's glucose levels and automatically pumping appropriate doses of insulin as determined by a computer algorithm.

Today's draft guidance document addresses an early version of an artificial pancreas system, known as a Low Glucose Suspend system.  The Low Glucose Suspend system can help reduce or lessen the severity of a dangerous drop in glucose levels (hypoglycemia) by temporarily reducing or stopping the delivery of insulin. However, patients must still manage their glucose levels with a glucose meter and give themselves insulin, if necessary. The draft guidance provides recommendations for those planning to develop and submit an application for a Low Glucose Suspend (LGS) system intended for single patient use in the home environment.  

The FDA is seeking inp
'/>"/>

SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Amylin Pharmaceuticals Issues Statement Regarding U.S. District Court Order
2. United Kingdoms National Institute for Health and Clinical Excellence Issues Guidance on Percutaneous Tibial Nerve Stimulation for Faecal Incontinence
3. BD Issues 2010 Sustainability Report
4. MedImmune To Present Eight Abstracts on Projects Regarding Thoracic and Respiratory Issues at the Annual American Thoracic Society International Conference
5. FDA Issues Final Guidance for Liquid OTC Drug Products With Dispensing Devices
6. Dehaier Medical Chairman and CEO Issues Letter to Shareholders
7. Omni Bio Pharmaceutical, Incs. CEO Issues Letter to Shareholders
8. The Centers For Medicare and Medicaid Services Issues Advance Guidance to Part D Plan Sponsors Allowing the Use of Generic Sampling as Medicare Part D Drug Utilization Management Tool.
9. New FDLIs Food and Drug Policy Forum Focuses on Liability Issues in Vaccine Design Defect Claims
10. UBM TechInsights Issues Warning to Medical Devices Industry About Possible Obsolescence as Reliance on Smartphones Increases
11. Qualitest Pharmaceuticals Issues Voluntary, Nationwide Recall of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg / 500 mg, NDC 0603-3888-20, 60 Count, Lot Numbers T150G10B, T120J10E and T023M10A and Phenobarbital Tablets, USP 32.4 mg, ND
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/17/2015)... 17, 2015 Research and Markets ( ... "Mammography Equipment - Global Strategic Business Report" report ... worldwide markets for Mammography Equipment in US$ Thousands by ... Mammography Equipment. The report provides separate comprehensive analytics for ... Japan , Europe , ...
(Date:4/17/2015)... 17, 2015  Over the next five years, the marijuana ... with ArcView predicting that 14 more states will legalize recreational ... U.S. market for legal cannabis grew 74 percent in 2014 ... project the market could grow more than fourfold to $11 ... their stance on marijuana. Cannabiz Mobile Inc. (OTCBB: ...
(Date:4/17/2015)... WASHINGTON , April 17, 2015 ... (PhRMA) honored 13 employees from 12 biopharmaceutical companies ... extraordinary efforts in policy advocacy and community service. ... for Health Champion Awards were created by the ... only excelled in their careers, but have also ...
Breaking Medicine Technology:Mammography Equipment (Analog & Digital) Market 2015-2020 - Global Strategic Business Report: Breast Imaging Screening Programs Push Sales 2Cannabiz Mobile Analyst Brief: Next Big Thing by Torus IR Issued by BrokerBank Securities, Inc. 2PhRMA Applauds 2015 We Work For Health Champion Award Winners 2PhRMA Applauds 2015 We Work For Health Champion Award Winners 3
... 30 Transgenomic, Inc. (OTC,Bulletin Board: TBIO), a ... National Cancer Institute had approved a proposal to,perform ... in,the NCI 60 cancer cell line panel., ... warning,signal in several different types of cancer. This ...
... Spherix Incorporated,(Nasdaq: SPEX ) announced today that it ... manufacturer of bulk pharmaceutical ingredients,to supply a portion of ... of the unique sugar as a treatment for Type ... Practice) production batches,of D- tagatose for the Spherix New ...
Cached Medicine Technology:Transgenomic Establishes Collaboration With the National Cancer Institute to Investigate Mitochondrial Genome and Associated Nuclear Genes in Cancer Cell Lines 2Transgenomic Establishes Collaboration With the National Cancer Institute to Investigate Mitochondrial Genome and Associated Nuclear Genes in Cancer Cell Lines 3Spherix D-tagatose to be Supplied by Inalco SpA 2
(Date:4/17/2015)... 17, 2015 Scientists from the ... team of U.S. and Venezuelan researchers, have discovered ... humans among an isolated tribe of Yanomami Amerindians ... diversity in the Yanomami, previously unexposed to antibiotics ... double that of people living in industrialized countries, ...
(Date:4/17/2015)... Compare-autoinsurance.org has released a new blog ... auto insurance quotes . , The online environment ... their cars. Drivers should always compare multiple car insurance ... market is a competitive one, which means that customers ... , It is now possible to compare online car ...
(Date:4/17/2015)... Nomedexamlifeinsurance.com has released a new blog post explaining how ... , Smoking is linked to numerous diseases like cancer ... smokers more money for life insurance plans. Someone who ... can qualify for advantageous offers. , The life ... non-smokers. Comparing quotes is the best method of reducing ...
(Date:4/17/2015)... Fairfax, VA (PRWEB) April 17, 2015 ... America , an estimated 50 million Americans suffer from ... latex, insect, skin and eye allergies. Thanks to comprehensive ... Primary Care ( caremedurgentcare.com ), there’s now a way ... and summer weather. , “Allergy triggers, or allergens, can ...
(Date:4/17/2015)... North Carolina (PRWEB) April 17, 2015 TouchCare ... for physicians, health care providers and their patients to use ... calls anytime, anywhere. The new version has a completely redesigned ... up a profile and invite a patient to connect for ... time, the app is now available on Android as well ...
Breaking Medicine News(10 mins):Health News:Mount Sinai Scientists Find Unprecedented Microbial Diversity in Isolated Amazonian Tribe Previously Unexposed to Antibiotics or Processed Foods 2Health News:Mount Sinai Scientists Find Unprecedented Microbial Diversity in Isolated Amazonian Tribe Previously Unexposed to Antibiotics or Processed Foods 3Health News:The Best Auto Insurance Quotes Are Available Online! 2Health News:Life Insurance Quotes for Smokers Available Online 2Health News:CareMed Urgent & Primary Care Now Offering Comprehensive Allergy Testing 2Health News:CareMed Urgent & Primary Care Now Offering Comprehensive Allergy Testing 3Health News:TouchCare Now Connects Android Users to Their Doctors, And Delivers Sleek New Interface For All 2Health News:TouchCare Now Connects Android Users to Their Doctors, And Delivers Sleek New Interface For All 3
... Nov. 21 The Providence Service,Corporation (Nasdaq: PRSC ... Officer, has been appointed to the Company,s Board of,Directors. ... 2008,resignation of Steven I. Geringer and returns the board to ... of the Board. , ...
... The University of Texas M. D. Anderson Cancer Center ... in Panama through the Partnership for Breast Cancer Awareness and Research ... First Lady of the United States, and Vivian Fernandez de Torrijos, ... Joining M. D. Anderson in the initiative are the U.S. ...
... membership of the Medical,Advertising Hall of Fame voted to induct three ... 2009 at the Pierre hotel in New York. A,Lifetime Achievement Award ... The 2009 inductees into the Medical Advertising Hall of Fame are: ... an account position,at Sudler & Hennessey. In 1980 he left Sudler ...
... B.C., a new and deadly diseaseits cause remains a mysteryswept ... soldiers and refugees of the war then raging between Athens ... down. Over the next three years, the illness returned twice ... the war too. The Plague of Athens marked the beginning ...
... Innerscope Research(TM), a revolutionary,biometric media research firm specializing ... three executives who will strengthen the,company,s research and ... The three appointments, who ... Gill as Chief Financial Officer and Vice President ...
... Gilbert Hospital, known for setting new trends in ... campaign entitled S.M.I.L.E. The acronym, which stands for Service; ... Directors Donna Ritchie of Inpatient Services and Carolyn Masood ... S.M.I.L.E. campaign came to life in order to provide ...
Cached Medicine News:Health News:Craig A. Norris Appointed to Providence Service Corporation Board of Directors 2Health News:Craig A. Norris Appointed to Providence Service Corporation Board of Directors 3Health News:First Lady Laura Bush's Partnership for Breast Cancer Awareness and Research Extends to Panama 2Health News:First Lady Laura Bush's Partnership for Breast Cancer Awareness and Research Extends to Panama 3Health News:Ronald Pantello, Harry Sweeney, and David Wood Voted Into Medical Advertising Hall of Fame. 2Health News:Ronald Pantello, Harry Sweeney, and David Wood Voted Into Medical Advertising Hall of Fame. 3Health News:Study of ancient and modern plagues finds common features 2Health News:Study of ancient and modern plagues finds common features 3Health News:Study of ancient and modern plagues finds common features 4Health News:Innerscope Research Strengthens Management Team With Three Executive Appointments 2Health News:Gilbert Hospital Kicks Off New Customer Service S.M.I.L.E. Campaign 2
... standards set by the new SZ61 and ... "Comfort View eyepiece design and the accessible, ... fatiguing than ever before. The compact design ... field as well as clarity, detail, and ...
The modular, high-end stereomicroscope; meets even the most critical demands in research and quality control provides high-contrast images with excellent depth of field and color fidelity...
A compact stereomicroscope that is immediately ready for operation and extremely easy to use. Focused on the essential performance features, the Stemi DV4 design concept provides optimum utility....
10:1 Zoom Ratio - The parallel optical system of the SMZ-1000 has a 10:1 zoom with clickstops at 1X intervals. It features a zoom range of 0.8X to 8.0X and total magnification (depending on eyepieces...
Medicine Products: