Laborie Medical Technologies Receives FDA Pre-Market Clearance For TETRA-NIRS Accessory

Williston, VT - Laborie Medical Technologies recently announced that the TETRA-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 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 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 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.

SOURCE: Laborie Medical Technologies