Laborie Medical Technologies has reported that its Tetra-NIRS system has received FDA clearance to proceed with marketing efforts in the US.
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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.
Laborie Medical Technologies is initiating final product packaging as per its internationally-recognized quality system so that Tetra can be made available to the broadest urological and pelvic floor assessment installed base.
Ing Han Goping, CEO of Laborie, said: “Tetra is expected to provide insight into bladder activity using non-invasive laser patch technology. Tetra 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 luminary network of Aquarius and Triton centers of excellence.”
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