Gwenn Ellerby

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Non-Invasive Physiological Sensor

Product Development

product-dev-1

Goals:

Develop sensor for monitoring muscle physiology parameters non-invasively

  • Versions for wired and mobile use
  • For use in trauma, EMS, and ambulatory medicine, including military
  • FDA compliant, safe, and intuitive

Roles:

  • Generate specifications and prototype validation testing plans
  • Manage collaborations with contract engineers and research sites
  • Design disposables to contour to 3 body locations, maintain optical contact
  • Create software automation logic and user interface layouts

Results:

CareGuide 1100, 2100, 3100 & 4100 product lines developed

  • 5 successful FDA 510(k) submissions, including approval for SmO2 and pHm
  • CareGuide is the first and only non-invasive pH monitor
  • Used at over 10 clinical, military, and research sites across the US and in Thailand

Related

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