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.
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