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Public Workshop - Innovations in Technology for the Treatment of Diabetes: Clinical Development of the Artificial Pancreas (an Autonomous System), November 10, 2010

Tue, 10/12/2010 - 7:34am
U.S. Food & Drug Administration

The Food and Drug Administration (FDA) in collaboration with the National Institutes of Health (NIH) are announcing a public workshop to facilitate medical device innovation in the development of the Artificial Pancreas (or Autonomous System) for the treatment of Diabetes Mellitus. An Artificial Pancreas is a medical device that links a glucose monitor to an insulin infusion pump where the pump automatically takes action (using a control algorithm) based upon the glucose monitor reading. As control algorithms can vary significantly, there are a variety of Artificial Pancreas Systems currently under development. These systems span a wide range of device design from Low Glucose Suspend device systems to the more complex Bihormonal Control-to-Target systems. Current research in this area use existing medical device technology, which have inherent limitations regarding performance and may pose additional obstacles that need addressed during the clinical evaluation of these investigational systems. FDA and NIH seeks feedback on ways to overcome obstacles towards the development of an artificial pancreas and what might be considered reasonable clinical expectations for systems considering the available existing technology.

The purpose of the workshop is to discuss the current state of device systems for autonomous systems for the treatment of Diabetes Mellitus, the challenges in developing this expert device system using existing technology, a discussion of the clinical expectations for these systems and a discussion of development plans for the transition of this device system toward an outpatient setting.


For information regarding logistics, registration and special accommodations, contact:

  • Susan Monahan

    Office of Communication, Education, and Radiation Programs

    Center for Devices and Radiological Health

    Food and Drug Administration

    10903 New Hampshire Avenue, Bldg. 66

    Silver Spring, MD 20993

    phone: 301-796-5661

    email: Susan.Monahan@fda.hhs.gov

  • Victoria Wagman

    Office of Center Director

    Center for Devices and Radiological Health

    Food and Drug Administration

    10903 New Hampshire Avenue, Bldg. 66

    Silver Spring, MD 20993

    phone: 301-796-6581

    email: Victoria.Wagman@fda.hhs.gov

For information regarding the program, contact:

  • Charles Zimliki, Ph.D.

    Chair, Critical Path & InterAgency Artificial Pancreas Working Groups

    Division of Anesthesiology, General Hospital, Infection Control & Dental Devices

    Office of Device Evaluation

    Center for Devices and Radiological Health

    Food and Drug Administration

    phone: 301-796-6297

    email: Charles.Zimliki@fda.hhs.gov

    

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