HemoSonics, based in Charlottesville, Virginia, won FDA de novo approval for its Quantra QPlus System and accompanying QPlus cartridge for point-of-care coagulation analysis. The system provides easy and rapid coagulation status, requiring only about a minute of labor from clinicians for each test. Initial results are available in about five minutes and the rest within about fifteen minutes.
The system uses a sealed, disposable cartridge inside of which a panel of viscoelastic blood coagulation tests is run. Along with traditional measures, the system can assess platelet contribution to clot stiffness and the chance that residual heparin is in the tested sample.
The cartridge relies on the firm’s own SEER sonorheometry ultrasound technology, which is essentially fully automated and doesn’t expose clinicians to patient blood. There’s no pipetting necessary and the system isn’t sensitive to vibration, making it easy to use in busy clinical environments.
“Critical bleeding occurs frequently in cardiac and major orthopedic surgeries,” said Timothy Fischer, President and Chief Executive Officer of HemoSonics. “The Quantra QPlus System revolutionizes point-of-care management by delivering accurate and novel results in a fraction of the time required previously, near the OR, surgical suite, or ICU. Faster results can mean better management of critical bleeding, more cost-effective treatment, and ultimately better outcomes for patients.”
Product page: Quantra System…
Via: HemoSonics…
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