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Laborie Medical Technologies Receives FDA Pre-Market Clearance for TETRA(TM)


3/10/2008 8:47:27 AM

WILLISTON, Vt., March 10 /PRNewswire/ -- Laborie Medical Technologies today announced that the TETRA(TM)-NIRS (Near Infrared Spectroscopy) system was given clearance to proceed with marketing efforts for this new and exciting technology in the USA by the US Food and Drug Administration (USFDA).

Laborie Medical Technologies is initiating final product packaging as per its internationally-recognized quality system (ISO-13485) so that TETRA(TM) can be made available to the broadest urological and pelvic floor assessment installed base.

"TETRA(TM) is expected to provide insight into bladder activity using non-invasive laser patch technology. TETRA(TM) has been tuned to analyze bladder outlet obstruction as well as bladder activity not readily available on simple uroflowmetry. Further studies towards additional uses are being made available through our extensive luminary network of Aquarius and Triton centers of excellence," says Ing Han Goping - CEO of LABORIE.

Preparations are underway to provide new and existing LABORIE clients compatibility with TETRA(TM) via appropriate upgrade paths. These upgrade options will allow many LABORIE users to preserve their existing investments as much as possible when adapting the new infrared measurement modality.

About Laborie Medical Technologies

Founded in 1967 by Ray Laborie, Laborie Medical Technologies is the leading global manufacturer of urodynamics equipment used in the diagnosis and treatment of incontinence, BPH, and voiding dysfunction.

As LABORIE enters its 41st anniversary in business, it has established itself as "the" supplier of pelvic floor assessment systems in many of the key academic centers. LABORIE's AQUARIUS Wireless Urodynamic System is considered the benchmark diagnostic device for clinical trials and medical research.

LABORIE's product line includes: urodynamic diagnostics, biofeedback/stimulation systems, compact ultrasound, computerized and physical bladder modeling tools, EMR solutions, consumables, as well as accredited education.

The network of installed users has afforded LABORIE the opportunity to feed this network with new and exciting technology on a continuous basis. Recently, LABORIE introduced the world's most compact, high resolution USB ultrasound system (NuWav(TM)), and it intends on providing the TETRA(TM) technology in the same manner. LABORIE has offices in Canada, USA, Belgium, China, UK and now Paris, France and San Paulo, Brazil. It has direct sales and distribution networks in 52 countries across North America, Europe, Asia and Oceania.

CONTACT: Peter J. Bulla, Vice President, Sales and Marketing, for Laborie
Medical Technologies, +1-802-857-1300, pbulla@laborie.com

Web site: http://www.laborie.com//


Read at BioSpace.com


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