Difference between revisions of "Cefaly"

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[http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm388765.htm Announcement about approving migraine treat]
 
[http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm388765.htm Announcement about approving migraine treat]
 +
 
[http://www.accessdata.fda.gov/cdrh_docs/pdf12/K122566.pdf Memo clearance]
 
[http://www.accessdata.fda.gov/cdrh_docs/pdf12/K122566.pdf Memo clearance]
  

Revision as of 22:58, 12 November 2015

CEFALY
Cefaly.jpg
Category Therapeutic wearables
Developer STX-Med
Announced -"-" contains an extrinsic dash or other characters that are invalid for a date interpretation.
Released Consumers: -"-" contains an extrinsic dash or other characters that are invalid for a date interpretation.
Price 299 USD
Weight g
Dimensions mm
Controls smartphone
Standalone[1]
http://www.cefalytechnology.com/en/company
http://www.cefalytechnology.com/en/products


Main characteristics

Purpose

Company & People

STX-Med company

Founders:

Pierre Rigaux

Pierre-Yves Muller

Important Dates

2004 - Foundation of STX-Med, which was later named Cefaly.[1]

Ethical Issues

Health Risks

Right on the official page of Cefaly side effects are stated.[2] Company claims, that side effects appear in 4,3% of patients, mentioning most common as intolerance to the feeling of Cefaly on the forehead (1.25%), sensation of fatigue during and after the session (0.65%), headache after one session (0.52%), or irritation of the skin on the forehead (0.22%).


Skin irritated probably because of electrode gel containing acrylate.[2]

Enhancement/Therapy/Treatment

Electrode sends electric current through skin and affects trigeminal nerve.[3]

Public & Media Impact and Presentation

Cefaly has its own official facebook page since 2009, and after this, several pages about Cefaly for specific countries were created.

Public Policy

Announcement about approving migraine treat

Memo clearance

Related Technologies, Project or Scientific Research

References

  1. Shows if the device is a standalone wearable computer or if it needs to be connected to a processing unit to function.
  2. Magis D., Sava S., d’Elia T. S., Baschi R., Schoenen J., Safety and patients’ satisfaction of transcutaneous Supraorbital NeuroStimulation (tSNS) with the Cefaly® device in headache treatment: a survey of 2,313 headache sufferers in the general population http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4177534/
  3. Magis D., Sava S., d’Elia T. S., Baschi R., Schoenen J., Safety and patients’ satisfaction of transcutaneous Supraorbital NeuroStimulation (tSNS) with the Cefaly® device in headache treatment: a survey of 2,313 headache sufferers in the general population http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4177534/