ZYTO CORP (OTC:ZYTC) , 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. According to Section 510(k) of the United States Food, Drug and Cosmetic Act, the manufacturers of the medical device have to register themselves with the US Food and Drug Administration (FDA) and give a prior notice of 90days about their intent to market a medical device.
Premarket Notification was filed in May, 2011 wherein the FDA issued its fortitude that the Hand Cradle was substantially correspondent to other galvanic skin response measurement devices on 30th August, 2011. Quoting Vaughn R Cook, OMD, ZYTO’s CEO, “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.” ZYTO foresees the registration to have a universal impact.
The global marketing partners of the Company have accelerated their activities in expectancy of this registration. This achievement would make the associates of ZYTO more aggressive in their sales efforts. According to Mr. Kami J. Howard, ZYTO’s President, the Company we expects an growth of their promotion and use of ZYTO technology. “The last 18 months have been significant for ZYTO,” said 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.”
Shares of ZYTC closed 36.71% lower after rising 70% earlier in the session with 365K shares traded hands on Friday.
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