Indian Wells, California (PRWEB) October 15, 2015
The Eye Machine, LLC is pleased to announce the addition of Dr. Morris Waxler as the company’s new Director of Regulatory Affairs. Dr. Waxler spent 26 years with the Food and Drug Administration in a variety of prominent positions, including Former FDA Chief, Diagnostics and Surgical Devices, Ophthalmic Devices from 1996-2000. As Chief, Dr. Waxler approved clinical research and market applications for laser vision correction, popularly known as LASIK.
As Director of Regulatory Affairs, Dr. Waxler will be ensuring company compliance with all FDA regulations, including, but not limited to clinical studies, preparation of safety and effectiveness documents, and quality system rules . He will play an instrumental role in assisting The Eye Machine as they move towards regulatory authorization of their non-invasive micro-current therapy for dry macular degeneration.
Dr. Waxler formed Waxler Regulatory Consultancy in 2007 after working as an FDA regulatory affairs consultant at two prestigious law firms: Hogan & Hartson, LLP in Washington, DC and Godfrey & Kahn, SC in Madison, WI. Dr. Waxler has, and continues, to serve manufacturers of a wide-range of devices: retinal evaluation, cancer diagnosis, dental products, pain relief, software diagnosis, coated catheters, wound cleaners, and implanted cardioverters. Also he was compliance officer for a major manufacturer of cardiovascular devices to assure compliance with a Corporate Integrity Agreement with the Department of Health and Human Services.
About The Eye Machine:
The Eye Machine, LLC was formed to develop, manufacture, and lease to medical professionals an electrotherapeutic device to treat visual disease, by providing a non-invasive micro-current therapy for dry macular degeneration. This treatment method can help mitigate the effects of age-related macular degeneration.
The Eye Machine’s micro-current therapy represents a new, non-invasive treatment for dry macular degeneration. The device output signal is structured to provide a range and pattern of frequencies to stimulate the desired physiologic response at the retinal level. This low current has been shown by studies to stimulate the production of the active transport enzyme, adenosine triphosphate (“ATP”), which facilitates the movement of nutrition from the blood to the cell. According to recent studies, this treatment improves permeability of the blood vessel membranes and cells, allows better oxygen and nutrition delivery to the cells, metabolism, and removal of by-products from the cells. Through these mechanisms, micro-current therapy improves retinal pigment epithelium (“RPE”) efficiency and in so doing may restore and/or improve retinal function.
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