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News

Laborie’s new NIR system receives FDA pre-market clearance

Laborie Medical Technologies : 11 March, 2008  (New Product)
Laborie Medical Technologies’ Tetra-NIRS (Near Infrared Spectroscopy) system has received clearance by the US Food and Drug Administration to proceed with marketing efforts for this new technology in the USA.
Laborie Medical Technologies is initiating final product packaging as per its internationally recognised quality system (ISO-13485) so that Tetra can be made available to the broadest urological and pelvic floor assessment installed base.

'Tetra is expected to provide insight into bladder activity using non-invasive laser patch technology. Tetra has been tuned to analyse 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 centres of excellence,' said Ing Han Goping, chief executive offcicer of Laborie.

Preparations are underway to provide new and existing Laborie clients compatibility with Tetra 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.
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