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Fisher Wallace Laboratories

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Fisher Wallace Laboratories, Inc., headquartered in New York City, markets the Fisher Wallace Stimulator, a cranial electrotherapy stimulation (CES) device.[1][2] The company was founded in 2007 by entrepreneur Charles Avery Fisher, son of electronics pioneer Avery Fisher, and Martin Wallace.[3][4] The company acquired its lead product from Saul and Bernard Liss in 2006.[4] Inc. magazine rated the company as being #983 (in 2014) and #1447 (in 2015) in its "Inc. 5000" listing.[5][6] The Lisses had already obtained 510K marketing clearance from the Food and Drug Administration to treat anxiety, depression, and insomnia when Fisher-Wallace acquired it.[7]

Fisher-Wallace renamed the device as the FW-100 Cranial Stimulator Device, and it was approved for marketing by Health Canada in 2014 under Licence No. 92984; in 2015 Health Canada received a complaint about Fisher Wallace's marketing on its website and sent an enforcement letter concerning the false marketing, which the company corrected.[8] A 2014 Cochrane review found insufficient evidence to determine whether CES devices with alternating current are safe and effective for treating depression.[9]

Fisher-Wallace is a late entry to the CES field; such devices have been marketed since the 1940s, especially in Russia.[3] It has heavily marketed its device via YouTube[3] and other media[10] with pitches that, according to Jessa Gamble writing in Aeon, have "all the trappings of a late-night infomercial".[4]

Fisher was credited by Neurotech Reports editor and publisher James Cavuoto with playing a leading role in the FDA's 2014 withdrawal of its earlier proposal to require companies marketing CES devices to conduct new clinical trials to prove the safety and efficacy of the devices and to submit Premarket Approval applications in order to continue marketing the devices;[11] the company had alleged that the FDA improperly barred an expert in the field from attending a 2014 advisory meeting to discuss the proposed regulation.[12] In 2016, in response to the FDA's next effort to regulate the device class, the company alleged that there was "evidence of regulatory misconduct" and called for an investigation.[13]

References

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  1. ^ Allison Shelley for Medscape News. February 17, 2012 Electrical Stimulators Need High-Risk Rating, Says FDA Panel
  2. ^ Staff, Sleep Review. June 11, 2014 FDA To Propose Approval/Reclassification of Cranial Electrotherapy Stimulation Devices for Insomnia
  3. ^ a b c Melinda Beck for the Wall Street Journal. Jan. 11, 2011 "Using Electricity, Magnets for Mental Illness"
  4. ^ a b c Jessa Gamble, New technologies are emerging that could radically reduce our need to sleep – if we can bear to use them, Aeon Magazine
  5. ^ "Fisher Wallace Laboratories". Inc. 2016. (In archive link, click on list that leads to #1447.)
  6. ^ Dagdeviren, Canan (December 1, 2017). "Event: Biotech Wearables for the Treatment of Mental Health Symptoms". MIT Media Lab. Retrieved 30 March 2018.
  7. ^ Mindes, Janet; Dubin, Mark J.; Altemus, Margaret (November 15, 2014). "Chapter 11 Cranial Electric Stimulation". In Knotkova, Helena; Rasche, Dirk (eds.). Textbook of Neuromodulation: Principles, Methods and Clinical Applications (2015 ed.). Springer. p. 129. ISBN 978-1493914074. Subsection: "Contemporary Devices and Clinical Applications".
  8. ^ "Health Product Advertising Complaints". Health Canada. 26 March 2015. Retrieved 28 September 2017.
  9. ^ Kavirajan HC, Lueck K, Chuang K (2014). "Alternating current cranial electrotherapy stimulation (CES) for depression". Cochrane Database Syst Rev. 7 (7): CD010521. doi:10.1002/14651858.CD010521.pub2. PMC 10554095. PMID 25000907. Rigorous clinical trial evidence is lacking on the use of cranial electrotherapy stimulation (CES) in acute depression. Thus, at present, there is insufficient evidence on which to base decisions for using CES in treatment of acute depression
  10. ^ John Horgan for Scientific American. June 24, 2015 Return of Electro-Cures: Symptom of Psychiatry's Crisis?
  11. ^ James Cavuoto, Neurotech Reports. June 2014 Editorial: Using Our Cranium
  12. ^ Mark McCarty for Medical Device Daily April 9, 2012 Fisher Wallace hints at FDA misconduct at CES advisory
  13. ^ Marie Thibault for MDDI. April 20, 2016 Patients, Clinicians Advocate for Cranial Electrotherapy Stimulators
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