Message #3 From:
Stock News Bot Date: April 22, 2005 09:59:23 AM
PMED Paradigm Medical Industries Files 510k With FDA for Next Generation UBM Device
Paradigm Medical Industries Files 510k With FDA for Next Generation UBM Device
SALT LAKE CITY--(BUSINESS WIRE)--April 22, 2005--Paradigm Medical Industries, Inc. (OTCBB: PMED.OB/PMEDW.OB) today announced it has filed a 510(k) with the U.S. Food and Drug Administration (FDA) for its new generation ultrasound biomicroscope (UBM). Last month, the Company was awarded the CE Mark for the P60 UBM, which will enable it to market the device in 19 Western European countries and some parts of the Pacific Rim.
A 510(k) is a formal marketing application to the FDA to gain clearance for specific indications of use for a device. With FDA approval, the new device will be available for sale in the United States.
"The P60 represents the latest generation of our UBM devices," said Paradigm Medical's Chief Operating Officer, Aziz A. Mohabbat. "We believe it has better visual clarity and image flexibility than earlier versions."
The UBM is Paradigm Medical's leading product, accounting for more than 25% of 2004 revenues.
The P60 represents the Company's fourth generation UBM device. The first three devices already have received U.S. FDA approval as well as the CE Mark. The UBM is used for viewing structures in the eye involved with glaucoma pathologies and surgical procedures.
Paradigm Medical Industries, Inc., currently develops, manufactures and markets surgical and diagnostic high-tech, proprietary equipment and consumable products for the medical industry. The Company's corporate headquarters are located at 2355 South 1070 West, Salt Lake City, Utah 84119. Call (801) 977-8970 or visit us at www.paradigm-medical.com.
This press release contains statements that, if not verifiable historic fact, may be viewed as forward-looking statements that could predict future events or outcomes with respect to Paradigm and its business. The predictions embodied in these statements will involve risk and uncertainties and, accordingly, actual results may differ significantly from the results discussed or implied in such forward-looking statements.
Contacts
Paradigm Medical Industries, Inc.
Aziz A. Mohabbat, 801-977-8970
