FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

HemoSonics’ Quantra QPlus System Earns De Novo Authorization

March 15, 2019
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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.

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