Fisher Wallace Laboratories‎

{{Short description|American electronics company}}

Fisher Wallace Laboratories, Inc., headquartered in New York City, markets the Fisher Wallace Stimulator, a cranial electrotherapy stimulation (CES) device.Allison Shelley for Medscape News. February 17, 2012 [http://www.medscape.com/viewarticle/758820 Electrical Stimulators Need High-Risk Rating, Says FDA Panel]Staff, Sleep Review. June 11, 2014 [https://web.archive.org/web/20150226230223/http://www.sleepreviewmag.com/2014/06/fda-propose-approvalreclassification-cranial-electrotherapy-stimulation-devices-insomnia FDA To Propose Approval/Reclassification of Cranial Electrotherapy Stimulation Devices for Insomnia] The company was founded in 2007 by entrepreneur Charles Avery Fisher, son of electronics pioneer Avery Fisher, and Martin Wallace.Melinda Beck for the Wall Street Journal. Jan. 11, 2011 [https://www.wsj.com/articles/SB10001424052748703779704576073762463762744 "Using Electricity, Magnets for Mental Illness"] The company acquired its lead product from Saul and Bernard Liss in 2006.Jessa Gamble, [http://aeon.co/magazine/psychology/jessa-gamble-life-without-sleep/ New technologies are emerging that could radically reduce our need to sleep – if we can bear to use them], Aeon Magazine Inc. magazine rated the company as being #983 (in 2014) and #1447 (in 2015) in its "Inc. 5000" listing.{{cite magazine |title=Fisher Wallace Laboratories |url=http://www.inc.com/profile/fisher-wallace-laboratories|magazine=Inc. |date=2016 }} (In archive link, click on list that leads to #1447.){{cite web|last1=Dagdeviren|first1=Canan|title=Event: Biotech Wearables for the Treatment of Mental Health Symptoms|url=https://www.media.mit.edu/events/biotech-wearables-for-the-treatment-of-mental-health-symptoms/|website=MIT Media Lab|access-date=30 March 2018|date=December 1, 2017}} 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.{{cite book |editor1-last=Knotkova |editor1-first=Helena |editor2-last=Rasche |editor2-first=Dirk |last1=Mindes |first1=Janet |last2=Dubin |first2=Mark J. |last3=Altemus |first3=Margaret |chapter=Chapter 11 Cranial Electric Stimulation |title=Textbook of Neuromodulation: Principles, Methods and Clinical Applications |date=November 15, 2014 |publisher=Springer |isbn=978-1493914074 |page=129 |edition=2015 |chapter-url=https://books.google.com/books?id=RXtqBQAAQBAJ&pg=PA129}} Subsection: "Contemporary Devices and Clinical Applications".

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.{{cite web|title=Health Product Advertising Complaints|date=26 March 2015 |url=https://www.canada.ca/en/health-canada/services/drugs-health-products/regulatory-requirements-advertising/health-product-advertising-complaints.html|publisher=Health Canada|access-date=28 September 2017|language=en}} A 2014 Cochrane review found insufficient evidence to determine whether CES devices with alternating current are safe and effective for treating depression.{{cite journal |vauthors=Kavirajan HC, Lueck K, Chuang K |title=Alternating current cranial electrotherapy stimulation (CES) for depression |journal=Cochrane Database Syst Rev |volume=7 |pages=CD010521 |year=2014 |issue=7 |pmid=25000907 |doi=10.1002/14651858.CD010521.pub2 |quote=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|doi-access=free |pmc=10554095 }}

Fisher-Wallace is a late entry to the CES field; such devices have been marketed since the 1940s, especially in Russia. It has heavily marketed its device via YouTube and other mediaJohn Horgan for Scientific American. June 24, 2015 [http://blogs.scientificamerican.com/cross-check/return-of-electro-cures-symptom-of-psychiatry-s-crisis/ Return of Electro-Cures: Symptom of Psychiatry's Crisis?] with pitches that, according to Jessa Gamble

writing in Aeon, have "all the trappings of a late-night infomercial".

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;James Cavuoto, Neurotech Reports. June 2014 [https://web.archive.org/web/20160601081641/http://www.neurotechreports.com/pages/publishersletterJun14.html Editorial: Using Our Cranium] 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.Mark McCarty for Medical Device Daily April 9, 2012 [https://www.medicaldevicedaily.com/servlet/com.accumedia.web.Dispatcher?next=bioWorldHeadlines_article&forceid=78855 Fisher Wallace hints at FDA misconduct at CES advisory] 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.Marie Thibault for MDDI. April 20, 2016 [http://www.mddionline.com/article/patients-clinicians-advocate-cranial-electrotherapy-stimulators-04-20-16 Patients, Clinicians Advocate for Cranial Electrotherapy Stimulators]