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FDA Issues Draft Guidance for Early Version of an Artificial Pancreas System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SILVER SPRING, Md., June 20, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today issued draft guidance that will help advance the development and approval of an artificial pancreas system to treat type 1 diabetes in the United States.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Today's draft guidance document addresses an early version of an artificial pancreas system, known as a Low Glucose Suspend system.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 The draft guidance provides recommendations for those planning to develop and submit an application for a Low Glucose Suspend (LGS) system intended for single patient use in the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:7/25/2014)... , July 25, 2014  CVS Caremark Corporation ... conference call on Tuesday, August 5, 2014, at 8:30 ... second quarter 2014 financial results. An audio ... through the Investor Relations portion of the CVS Caremark ... visit http://info.cvscaremark.com/investors . This webcast will be archived ...
(Date:7/25/2014)... 2014  Acsis Inc., the market leader for ... has recently posted an article, "Future of ... future needs for companies, extended supply chain, and ... model no longer work today.  The article explains ... of mobile technology, machine to machine (M2M) connectivity, ...
(Date:7/25/2014)... Research and Markets has announced the addition ... report to their offering. ... An ophthalmic diagnostic device is a ... in the human visual pathway. Ophthalmic devices are used ... glaucoma, retinal disorders, conjunctivitis, and dry eyes. ...
Breaking Medicine Technology:Acsis Addresses Questions on the Modern Supply Chain 2Global Ophthalmic Diagnostic Devices Market 2014-2018: Key Vendors are Alcon, Carl Zeiss, Haag-Streit and Topcon 2
... on Mayo Clinic Discoveries is Developing Therapies for Wounds, ... Angiogenic Properties , , ... company,s novel technology platform which employs nano-materials made of ... wound healing, diabetic foot ulcers and hair growth are ...
... Dec. 14 Eisai Corporation of North,America today ... (FDA) has,approved LUSEDRA(TM) (fospropofol disodium) Injection, an intravenous,sedative-hypnotic ... adult,patients undergoing diagnostic or therapeutic procedures. , ... the FDA required that LUSEDRA be used only ...
Cached Medicine Technology:OmegaGenesis Unveils Novel Nanotechnology Platform With Broad Biomedical Applications 2OmegaGenesis Unveils Novel Nanotechnology Platform With Broad Biomedical Applications 3FDA Approves LUSEDRA(TM) (fospropofol disodium) Injection for Monitored Anesthesia Care (MAC) Sedation 2FDA Approves LUSEDRA(TM) (fospropofol disodium) Injection for Monitored Anesthesia Care (MAC) Sedation 3FDA Approves LUSEDRA(TM) (fospropofol disodium) Injection for Monitored Anesthesia Care (MAC) Sedation 4
(Date:7/27/2014)... 2014 Bags underneath the eyes is one ... and there are a range of new products now available ... a baggy eyes serum review that is now posted for ... explores the issues with baggy eyes and how the natural ... users. The guide also provides a detailed overview of the ...
(Date:7/27/2014)... hepatitis E virus (HEV) transmission by blood components indicates ... HEV in their plasma. The findings, published in ... components (eg, red cells, platelets, and fresh frozen plasma) ... , The study retrospectively screened 225 000 individual ... 2012 and Sept, 2013 for HEV RNA. 79 donors ...
(Date:7/27/2014)... Ticket Down is a reputable source for ... California on November 15th. This Australian boy band has recently ... songs from this amazing album at the concert. , Tickets ... The Forum will be released for sale to the general public ... TicketDown.com. This popular secondary ticket exchange can also be reached ...
(Date:7/27/2014)... According to a new market report ... Endoscopic Operative Devices, and Visualization Systems) - Global Industry ... global endoscopy devices market was valued at USD 24.9 ... a CAGR of 6.8% from 2013 to 2019, to ... 2019. , Endoscopy procedures are performed by inserting rod ...
(Date:7/27/2014)... Scientists from The University of Manchester have discovered why medication ... findings, published in Nature Medicine , show that drugs ... clock. , In the UK pneumonia, which is ... each year and is more serious for babies, young children, ... , More than 5 million people in the UK ...
Breaking Medicine News(10 mins):Health News:Baggy Eyes Serum Review Posted for Men and Women at Cherry News Website 2Health News:The Lancet: 1 in 3000 blood donors in England infected with hepatitis E 2Health News:5 Seconds of Summer Tickets at The Forum in Inglewood (Los Angeles), CA Now Available For Sale at Ticket Down 2Health News:Global Endoscopy Devices Market: Industry Analysis, Size, Share, Growth, Trends and Forecast 2013 - 2019 2Health News:Global Endoscopy Devices Market: Industry Analysis, Size, Share, Growth, Trends and Forecast 2013 - 2019 3Health News:Global Endoscopy Devices Market: Industry Analysis, Size, Share, Growth, Trends and Forecast 2013 - 2019 4Health News:Drugs used to treat lung disease work with the body clock 2
... Directors and Commits all ... Work to Benefit FASTeam, CHICAGO, July 7 Fetal ... Bifida, Down Syndrome and Muscular,Dystrophy combined, yet it is a ... prevention of prenatal alcohol exposure and,research examining the effects of ...
... play a major role in,keeping the bone marrow environment ... Tenn., July 7 The lack of a single,protein ... to,recycle molecules in cells causes an incurable and often ... Hospital investigators., Children with this disease, called sialidosis, ...
... chances of miscarriage for couple, study finds , , MONDAY, ... those in which the man is over age 35 have ... study shows. , To come to this conclusion, French researchers ... fertility clinic in France. , In most of the cases, ...
... San Francisco,s Largest AIDS Fundraising Event Goes GREEN with Online ... Communications, Recycling and Awareness, ... AIDS Walk San Francisco announced today key initiatives to ,Green, ... The,initiatives include the introduction of Green Walkers, composting, and,enhanced recycling., ...
... Athens Regional Medical Center and,Blue Cross and Blue ... multi-year contract, enabling Athens Regional to join the BCBSGa,HMO/POS ... PPO contract with,Athens Regional for many years., The ... throughout,Georgia will be able to gain complete access to ...
... Physicians Practice, America,s,Leading Practice Management Journal today ... to editorial director, Steven Gottshall to associate,publisher, ... promotions,are reflective of the company,s overall strategy ... into new physician focused markets and,circulation growth., ...
Cached Medicine News:Health News:K Squared Sponsors F.A.S.T. Ride 150-mile Motorcycle Tour August 17 2Health News:St. Jude Study Reveals a New Function for an Old Enzyme in Fatal Childhood Disease 2Health News:St. Jude Study Reveals a New Function for an Old Enzyme in Fatal Childhood Disease 3Health News:St. Jude Study Reveals a New Function for an Old Enzyme in Fatal Childhood Disease 4Health News:Father's Age a Factor in Infertility 2Health News:AIDS Walk San Francisco Takes Big Green Step Forward 2Health News:AIDS Walk San Francisco Takes Big Green Step Forward 3Health News:Blue Cross and Blue Shield of Georgia and Athens Regional Medical Center Announce New HMO/POS Contract 2Health News:Physicians Practice Promotes Key Executives 2
... Pupillometry in Critical Care & Emergency ... a hand-held, cordless, and simple to use ... the measurement of the pupillary light reflex ... pupillary function which are not discernable to ...
...
Inquire...
Using proven 1064 nm technology for the treatment of deeper lesions, the Lumenis One Multi-Spot Nd:YAG module provides versatility allowing targeted treatment of leg veins, vascular lesions, facial w...
Medicine Products: