Urodynamix Technologies Ltd., of Vancouver, Canada, announced that its worldwide distribution partner, Laborie Medical Technologies Inc., received approval to market their urodynamic equipment with the Tetra Bladder Monitor System for noninvasive bladder testing in the United States.
The product is a diagnostic device based on Urodynamix’s near infrared spectroscopy (NIRS) technology. Tetra uses NIRS to monitor bladder activity to aid in the diagnosis of patients with lower urinary tract symptoms.
“This initial regulatory approval was received ahead of schedule due to the prompt review by the FDA and thorough work of regulatory and R&D departments at both Urodynamix and Laborie,” said Barry Allen, Urodynamix president and CEO.
The two companies entered into a global licensing agreement last year to distribute NIRS technology in acute-care settings. Laborie’s launch of Tetra in America is scheduled to begin in the second quarter of 2008.