Dialysis Access Flow Device Cleared by FDA

A transcutaneous dialysis access flow device indicated for the estimation of blood flow has been cleared by the U.S. Food and Drug Administration (FDA).

Called TQa, the new technique provides real-time determination of vascular access blood flow rate based on relative changes in hematocrit. It eliminates the need for dialysis line reversal. TQa is the product of In-Line Diagnostics Corp. (Boston, MA, USA) and a complementary product to the company's Crit-Line platform. This platform is a noninvasive, stand-alone blood monitoring system employing proprietary photo-optical technology that enables the real-time measurement of vital whole blood parameters such as hematocrit, percent change in blood volume, and oxygen saturation.

"As a complement to the Crit-Line, the TQa will revolutionize the access blood flow market due to its minimal test time, accuracy, ease of use, and elimination of line reversal requirements,” said Michael Magliochetti, Ph.D., president and CEO of In-Line Diagnostics.




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