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research.laryngeal_robot [2013/11/11 13:46]
kolds1@johnshopkins.edu [Status and Results to Date]
research.laryngeal_robot [2013/11/11 13:47]
kolds1@johnshopkins.edu [Students:]
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 We also compiled further documentation including an FMEA, testing plan and user manual. These changes and documents were completed and reviewed in winter 2012. The FDA has classified the system as a low risk device, so we are now awaiting IRB approval for a human subjects study. We also compiled further documentation including an FMEA, testing plan and user manual. These changes and documents were completed and reviewed in winter 2012. The FDA has classified the system as a low risk device, so we are now awaiting IRB approval for a human subjects study.
-=====Future Plans===== 
-We are currently in the process of submitting a new inquiry to the FDA to determine the risk level of the RoboELF. After their response and (hopefully)approval,​ we plan to submit an IRB request for human clinical trials with the Johns Hopkins IRB board. We hope to begin clinical trials with the RoboELF at Johns Hopkins Hospital in spring 2013. 
  
-CS Masters student, Jon Kriss, plans to use the RoboELF as part of a thesis project performing video registration with a flexible endoscope held by the RoboELF. That project will be completed in spring 2013. 
 ===== Project Personnel ===== ===== Project Personnel =====
 ====Students:​==== ====Students:​====
-  * Jon Kriss, CS Masters student 
   * Kevin Olds, BME PhD candidate   * Kevin Olds, BME PhD candidate
-  * Elizabeth Cha (graduated BS), BME 
 ====Advisors:​==== ====Advisors:​====
   * Jeremy Richmon MD   * Jeremy Richmon MD
research.laryngeal_robot.txt · Last modified: 2019/08/07 12:01 (external edit)




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