Paramaxâ„¢ Moves Closer To FDA Approval
SALT LAKE CITY, May 19, 2011 /PRNewswire/ -- Paradigm Medical Industries, Inc. (OTC.PK: PDMI) announced today that it had received notification from its Italian partner, Costruzione Strumenti Oftalmici (CSO), which manufactures the Paramax™, that it has provided 26 pages and 24 attachments to the U.S. Food and Drug Administration (FDA) in order to obtain 510(k) approval for the Paramax™. This supportive information was submitted to the FDA for review on Monday, May 16, 2011. The Paramax™ is the next generation of standard ocular eletrophysiology utilized for early glaucoma detection. Paradigm will begin marketing and selling the Paramax™ in the United States upon receipt of the 510(k) approval.
"Paradigm is confident that CSO has provided the necessary additional information to the FDA to allow it to move forward with its decision to approve this valuable early glaucoma diagnostic device for sale within the United States within a reasonable amount of time," said Stephen L. Davis, Paradigm President and Chief Executive Officer.
"The Paramax™ represents one of the most reliable and durable early glaucoma diagnostic devices available in the U.S. market. It will also provide the earliest diagnosis of glaucoma available, potentially saving the vision for many who would have otherwise lost it," he added.
Sales for Paradigm's other glaucoma detecting device, the Blood Flow Analyzer™, have picked up in the United States as an increased number of physicians are realizing the dependable information derived from a 15 second test from the ocular blood flow device can lead to earlier medical intervention, thereby reducing the risk of further glaucoma-related vision loss.
"The anticipated pairing of the Paramax™ and the time-tested Blood Flow Analyzer™ will offer the most current and dynamic combination of tools available to physicians for the early detection and treatment of glaucoma," continued Mr.