Vivos Inc (RDGL)

[Timing101]

Recommend to get on Twitter and / or website RDGL and
send messages for updates... just did also
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Looking for more add on to this and also any Conversions info
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Note on " ALL ANIMALS", goes with Korenko statement Human Trials
forthcoming
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Richland WA, Jan. 11, 2019 (GLOBE NEWSWIRE) -- Vivos, Inc. (OTCPINK: RDGL), announced that the device classification obtained from the FDA Center for Veterinary Medicine (CVM) is not limited to canine and feline sarcomas, and can be extended to a much broader population of veterinary cancers, essentially all solid tumors in animals.

A review by the international law firm, Hogan-Lovells, who are premier experts on FDA matters, confirmed the broader application of the FDA’s veterinary device classification. While the FDA does not have premarket authority over veterinary devices (i.e., products classified as a device can be brought to market without first being reviewed by the FDA) the manufacturer is responsible for assuring that the product is safe, effective, properly labeled, and otherwise in compliance with all applicable laws and regulations.

It is the company’s responsibility to maintain a strict configuration control of the product and product labeling, including applicable indications for use, to stay within the bounds of the FDA regulations. We have prepared a formal Memorandum to File to document our systematic interpretation of the regulations and our disciplined process for assuring compliance with FDA requirements.

Dr. Mike Korenko, Vivos Inc CEO stated “With this significant development we are confident that there are no regulatory obstacles to treating a wide range of tumors in animals. We intend to continue with our strategy of partnering with university veterinary hospitals to generate additional data on the safety and effectiveness of IsoPet® therapy in order to enhance the confidence of the veterinary medicine community. We will also ensure that future users obtain our certified training to administer IsoPet® according to the procedures defined in our product labeling.”