www.fdanews.com/articles/190576-hemosonics-quantra-qplus-system-earns-de-novo-authorization
HemoSonics’ Quantra QPlus System Earns De Novo Authorization
March 14, 2019
The FDA granted HemoSonics de novo marketing authorization for its Quantra Hemostasis Analyzer platform, a device that checks a patient’s blood coagulation status.
The point-of-care ultrasound system gives rapidviscoelastic results in 15 minutes or less, with hands-on time of less than a minute.
The device uses a sealed consumable cartridge to conduct a panel of viscoelastic blood coagulation tests. The results can be used in managing critical bleeding after cardiac and orthopedic surgeries.