ZYTO Corp., a company that engages in manufacturing and distributing bio-communication devices and software that facilitate communication between computers and the human body to healthcare professionals, has recently announced that its 510(k) filing with the U.S. Food and Drug Administration (FDA) for the ZYTO Hand Cradle has been approved. Vaugh R. Cook, OMD, CEO of ZYTO, announced, “This is a significant milestone for the company, bringing additional credibility to our technology and expanding our markets. FDA registration comes with the requirement for increased regulatory compliance and that provides our customers more confidence in our actions as a company and in the integrity of our products.”
Section 510(k) of the U.S. Food, Drug, and Cosmetic Act requires medical device manufacturers to register with the U.S. FDA and inform them of their intent to market a medical device at least 90 days in advance. The 510(k) submission allows for the FDA to determine whether an applicant’s device is “substantially equivalent” to a similar device that is already on the market. ZYTO filed its Section 510(k) Premarket Notification in May of this year, and on August 30, 2011, the FDA issued its determination that the Hand Cradle was substantially equivalent to other galvanic skin response measurement devices.
ZYTO expects that this registration will have a global impact. Kami J. Howard, ZYTO’s President, stated, “We have global marketing partners who have been pacing their activities in anticipation of this registration. This achievement will allow them to accelerate their pace and become more aggressive in their sales efforts. Over the next several months we expect an expansion of their promotion and use of ZYTO technology.”
“FDA registration opens the door to more research opportunities. We’ve been in discussion with researchers in the United States and internationally and expect very shortly to announce the launch of the next project in our ongoing research effort,” added Dr. Cook.
“The last 18 months have been significant for ZYTO,” emphasized Ms. Howard. “Between our SEC qualification and subsequent listing as a Bulletin Board company, and now this registration with the FDA, a lot has happened. It’s required hard work and significant expense, but it’s all part of our strategy for growth and enhancing value for ZYTO stakeholders.”
For more information on ZYTO Corporation, visit their website at: http://www.zyto.com
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