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Paradigm Medical Receives FDA Approval for New-Generation Ultrasound Devices Collaboration with China's MEDA results in development of new array of devices ready to meet global market needs Feb 7, 2007 9:04:00 AM Copyright Business Wire 2007
SALT LAKE CITY--(BUSINESS WIRE)--
Paradigm Medical Industries, Inc. (OTCBB: PMED.OB/PMEDW.OB), a leading innovative producer of ultrasound devices for the ophthalmic and medical industries, disclosed today it has received U.S. Food and Drug Administration (FDA) approval to market a new generation of Ultrasound devices. The products were developed through a collaboration with MEDA Co. Ltd., one of China's leading developers and manufacturers of ultrasound devices. The collaboration was formed in June 2006.
The new devices were unveiled at the recent American Academy of Ophthalmology (AAO) Convention, and have already received orders internationally.
"The FDA's approval of our 510(k) application will result in an immediate, stepped-up marketing campaign in the U.S. and Canada," said Paradigm Medical's Chief Executive Officer, Raymond Cannefax. "The Company has already built inventories based on strong international demand and anticipated U.S. regulatory approval."
The new devices include the P2000 A-Scan (used to measure axial length of the eye); P2200 Pachymeter (used for measuring corneal thickness); P2500 A-Scan/Pachymeter (a combination of the two stand-alone devices); P2700 AB/Scan (an ultrasound imaging device for detecting abnormalities within the eye); and P37-II (a more advanced AB/Scan used to provide portability for ophthalmology veterinary applications). "We believe the P37-II will set the new gold standard for AB/Scan in the industry," Mr. Cannefax noted.
"FDA approval for use of these devices and the recent operations management reorganization we implemented at the beginning of this year will have a favorable effect on our performance in 2007 and beyond," Mr. Cannefax added. "The Company clearly has become one of the leading, multi-product Ultrasound device producers in the world."
Paradigm Medical Industries, Inc. (Salt Lake City, UT), currently develops, manufactures and markets high-tech, proprietary diagnostic equipment and consumable products for the medical industry. The Company is a leading developer of Ultrasound devices, and has been dubbed "The UBM Company" (Ultrasound BioMicroscope). Contact us at 801-977-8900 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 and 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.
Source: Paradigm Medical Industries, Inc.
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