www.fdanews.com/articles/210370-hemosonics-quantra-hemostasis-system-with-qstat-cartridge-cleared-for-expanded-use
HemoSonics Quantra Hemostasis System with QStat Cartridge Cleared for Expanded Use
December 5, 2022
The FDA has granted an expanded 510(k) clearance to HemoSonics’point-of-care Quantra hemostasis system with QStat Cartridge to include trauma and liver transplantation procedures.
This system measures the coagulation properties of whole blood in 15 minutes or less, helping clinicians determine which specific blood products patients need.
Using a proprietary ultrasound technology, Quantra is the only whole blood hemostasis testing system specifically cleared for use in point-of-care settings, such as operating rooms, emergency departments, and intensive care units, the company said.