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FDA Issues Draft Guidance for Early Version of an Artificial Pancreas System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

ut from industry, researchers, the clinical community, and other stakeholders on the draft Low Glucose Suspend guidance. Specifically, the agency is interested in the types of clinical studies that should be conducted and what their target outcomes should be to demonstrate safety and effectiveness, necessary requirements for FDA approval.

"Our goal is to provide a clear pathway for artificial pancreas development so that people with diabetes can benefit from innovative medical devices," said Jeffrey Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health. "Getting a safe and effective artificial pancreas system to Americans with type 1 diabetes is an FDA priority."

The FDA currently is working on a second draft guidance that will help manufacturers and researchers develop more autonomous artificial pancreas systems. That guidance is expected to be issued by the end of the year.

For more information:

Draft Guidance http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm259301.htm

FDA: Artificial Pancreas Systems

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/ConsumerProducts/ArtificialPancreas/default.htm

FDA: Medical Devices

http://www.fda.gov/MedicalDevices/default.htm

CDC:  Centers for Disease Control and Prevention—Diabetes Public Health Resource

http://www.cdc.gov/diabetes/

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of hu
'/>"/>

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:12/19/2014)... WORTH, Texas , December 18, 2014 /PRNewswire/ ... a networked software application/module that is used to ... related images. RIS comprises a patient tracking and ... system. The integration of RIS with HIS and ... used for patient registration and patient scheduling, patient ...
(Date:12/19/2014)... Dec. 18, 2014 Capnia, Inc. (NASDAQ: ... of medical diagnostics based on its proprietary Sensalyze™ ... today announced financial results for the third quarter ... "Following the completion of our initial public ... maximize the recently initiated CoSense® commercial launch," said ...
(Date:12/19/2014)... and LYON, France , Dec. ... LLY ) and Adocia (Euronext Paris: FR0011184241 – ... developing an ultra-rapid insulin, known as BioChaperone Lispro, for ... diabetes. BioChaperone Lispro relies on Adocia,s proprietary BioChaperone® technology ... Lilly and Adocia will develop BioChaperone Lispro with the ...
Breaking Medicine Technology:The Global Radiology Information Systems Market is Expected to Grow at a CAGR of 7.5% from 2014 to 2019 2The Global Radiology Information Systems Market is Expected to Grow at a CAGR of 7.5% from 2014 to 2019 3Capnia Reports Third Quarter 2014 Financial Results 2Capnia Reports Third Quarter 2014 Financial Results 3Capnia Reports Third Quarter 2014 Financial Results 4Capnia Reports Third Quarter 2014 Financial Results 5Capnia Reports Third Quarter 2014 Financial Results 6Capnia Reports Third Quarter 2014 Financial Results 7Capnia Reports Third Quarter 2014 Financial Results 8Lilly and Adocia Announce Alliance to Co-Develop Ultra-Rapid Insulin Based on BioChaperone Technology 2Lilly and Adocia Announce Alliance to Co-Develop Ultra-Rapid Insulin Based on BioChaperone Technology 3
... and VANCOUVER, British Columbia, Feb. 28, 2011 ... announced today that Scott Cormack, OncoGenex,s president and chief ... on novel cancer treatments at the upcoming RBC Capital ... Treatments: Under the Radar Unique Late-Stage Opportunities ", will ...
... REDWOOD CITY, Calif., Feb. 28, 2011 At the ... Inc. (Nasdaq: CDXS ) will announce significant ... carbon dioxide emissions from coal-fired power plants.  The program ... Coal-fired power plants are major emitters of carbon dioxide, ...
Cached Medicine Technology:OncoGenex Pharmaceuticals to Participate in Panel Discussion on Novel Cancer Treatments at RBC Capital Markets Healthcare Conference 2Codexis Announces Carbon Capture Progress at ARPA-E Summit 2Codexis Announces Carbon Capture Progress at ARPA-E Summit 3
(Date:12/19/2014)... It’s very easy to become overwhelmed with ... put to the wayside until Christmas and the New Year ... “itch” and that burning desire to just escape it all ... journey to Telluride with a no-fuss, affordable package. Montrose Days ... the resort, and ensure that all accommodations are met. Plus, ...
(Date:12/19/2014)... (PRWEB) December 19, 2014 Sub Zero Ice ... sponsor a blood drive Sunday the 28th from 2pm-6pm at ... & Sawyer Road in Sarasota, FL. , Inquiries regarding time ... you for participating in the donating process, Sub Zero Ice ... flash frozen, custom ice cream. , About Sub Zero Ice ...
(Date:12/19/2014)... The Plantrician Project , ... events, tools and resources for healthcare professionals and ... the world’s leading online cooking school, have joined ... needs: Culinary Rx. As an online food and ... scheduled for debut spring 2015, will be designed ...
(Date:12/19/2014)... Rosa, CA (PRWEB) December 19, 2014 ... and 5x5 SuperClone Rooms. SuperCloset continues to offer indoor ... solutions. Pair one of the new SuperClone Rooms with ... professional, perpetual, and turnkey indoor hydroponic grow room setup. ... in the world, SuperCloset’s SuperPonic SuperCloner 50 . ...
(Date:12/19/2014)... These vanadium reserves are mostly found in China, ... of vanadium were produced globally in 2013, up 11% ... 6.7% AAGR during the period from 2001 to 2013, ... largest consumer, accounted for more than 90% of total ... the chemical industry. , View Full Report at ...
Breaking Medicine News(10 mins):Health News:Days Inn Montrose Colorado Delivers Last Minute Holiday Season Ski Getaway Accommodations 2Health News:Shark Tank’s Sub Zero Ice Cream Sponsors Blood Drive 2Health News:The Plantrician Project and the Rouxbe Cooking School Join Forces to Develop Culinary Rx – a Plant-Prescription Course 2Health News:The Plantrician Project and the Rouxbe Cooking School Join Forces to Develop Culinary Rx – a Plant-Prescription Course 3Health News:The Plantrician Project and the Rouxbe Cooking School Join Forces to Develop Culinary Rx – a Plant-Prescription Course 4Health News:SuperCloset Continues to Innovate with New Complete Indoor Grow Room Packages, The SuperClone Rooms are the Newest Addition to the Award Winning SuperRoom Lineup 2Health News:Marketresearchreports.biz: Global Vanadium Usage Increased at AAGR of 6.7% between 2001 and 2013 2Health News:Marketresearchreports.biz: Global Vanadium Usage Increased at AAGR of 6.7% between 2001 and 2013 3
... from NewYork-Presbyterian Hospital/Weill Cornell Medical Center will present ... Association,s Annual Meeting in San Francisco, May 29 ... a urologist and professor of urology at NewYork-Presbyterian ... senior author and professor emeritus of urology at ...
... A minimally invasive technique used to destroy kidney tumors ... as surgical removal of tumors in curbing cancer recurrence ... In an article available online in the journal ... radiology at UT Southwestern Medical Center, reported the outcomes ...
... (BRONX, NY) The National Institutes of Health ... Medicine of Yeshiva University a five-year, $3.9 million grant ... in rural South Africa. The findings could alter public ... developing world. "Most cases of XDR-TB are thought ...
... ... demanding enterprise customers with VMware and Microsoft Hyper-V environments. , ... (PRWEB) June 2, 2010 -- VKernel, the ... announced today the general availability of VKernel Optimization Pack 1.4. The latest version ...
... aggressive ones, found in heaviest men, study says , WEDNESDAY, ... patients appears to be linked to patient weight, with heavier ... The finding stems from work involving more than 3,300 prostate ... surgery between 2001 and 2007 to remove a malignant prostate ...
... Risk aversion isn,t inevitable part of aging, researchers find ... says older people make less risky -- and less ... otherwise. , In some cases, older people make just ... people, researchers report. , "It,s not age, per se, ...
Cached Medicine News:Health News:NewYork-Presbyterian/Weill Cornell physician-scientists present at 2010 American Urological Meeting 2Health News:NewYork-Presbyterian/Weill Cornell physician-scientists present at 2010 American Urological Meeting 3Health News:Ablation proved as effective as traditional surgery in treating kidney cancer 2Health News:Einstein awarded NIH grant to study drug-resistant TB 2Health News:Einstein awarded NIH grant to study drug-resistant TB 3Health News:VKernel Raises Scalability and Reporting Bar with Optimization Pack 1.4 2Health News:Size of Prostate Tumor Linked to Patients' Weight 2Health News:Grandpa's Decision-Making Skills May Be Just Fine 2
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
Medicine Products: