Founded 2007 | ||
Fisher Wallace Laboratories, LLC, headquartered in New York City, markets the Fisher Wallace Stimulator, a cranial electrotherapy stimulation (CES) device. The company was founded in 2007 by entrepreneur Charles Avery Fisher, son of electronics pioneer Avery Fisher, and Martin Wallace. The company acquired its lead product from Saul and Bernard Liss. Inc. magazine rated the company as being #983 (in 2014) and #1447 (in 2015) in its "Inc. 5000" listing, reporting a three-year growth rate of 286%.
The Fisher Wallace Stimulator, previously known as the Liss Cranial Stimulator, received 510K marketing clearance from the Food and Drug Administration to treat depression, insomnia, anxiety, and chronic pain and is available in the U.S. only by prescription. The Fisher Wallace Stimulator is approved by Health Canada in the treatments of insomnia and chronic pain and is available without prescription in Canada.
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 media; 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; 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. 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.
A 2014 Cochrane review found insufficient evidence to determine whether or not CES devices with alternating current are safe and effective for treating depression.