Quantra® Hemostasis System with QStat® Receives FDA 510(k) Clearance
Next-Generation point-of-care whole blood hemostasis system now covers the broadest range of clinical indications in the U.S. to date. Durham, North Carolina – November, 30, 2022 – HemoSonics, LLC, a leading medical device company delivering individualized diagnostic solutions for Patient Blood Management (PBM), announced today that it has received 510(k) market clearance from the U.S. […]
New HemoSonics Medical Director Dr. Speiss Presents at Anesthesiology
Newly appointed Medical Director, Bruce Spiess, MD, FAHA to moderate the educational session “Listening to the Blood: An Update on the Quantra® System, the Latest Technology in the Management of Critical Bleeding” Clinical tools on display to provide actionable information to guide the management of critical bleeding enabling clinicians to choose the right treatment in […]
FDA Supports Viscoelastic Coagulation Analyzers for COVID-19 Patients
Charlottesville, VA, January 19, 2021 – HemoSonics welcomes the January 14th guidance of the US Food and Drug Administration (FDA) that broadens the use of viscoelastic coagulation analyzers for hospital patient healthcare settings in response to COVID-19. The FDA guidance is intended, for the duration of the COVID-19 public health emergency, to expand the availability […]
New Quantra® System Remote Viewer Enables Hospital-Wide Results
Charlottesville, VA – September 10, 2020 – HemoSonics announced today that its Quantra Desktop Remote Viewer Software (QDRV) has received a 510(k) clearance from the FDA. The QDRV enables remote access to its flagship product, the Quantra QPlus System. The Quantra System provides rapid, actionable coagulation results at the point of care – now viewable […]
Reducing QC Burdens in Viscoelastic Testing with the Quantra® System
How frequently do you have to run Quality Control (QC) on your viscoelastic testing (VET) device? What is the process for obtaining normal controls? How do you validate a new VET instrument for point-of-care use? These questions frequently arise when you are considering or evaluating a new VET point-of-care (POC) instrument. When it comes to […]
QStat® Cartridge Registered for Trauma & Liver Transplant with CE Mark
Charlottesville, VA – September 10, 2019 – HemoSonics is excited to announce that its new QStat Cartridge, an extension of its groundbreaking Quantra Hemostasis System, has registered for CE Mark and is now commercially available in Europe and Hong Kong. The utility of the Quantra System, which was previously available with the QPlus® Cartridge for […]
FDA Grants de novo for the HemoSonics’ Quantra® System with QPlus®
Charlottesville, VA, January 19, 2021 – HemoSonics welcomes the January 14th guidance of the US Food and Drug Administration (FDA) that broadens the use of viscoelastic coagulation analyzers for hospital patient healthcare settings in response to COVID-19. The FDA guidance is intended, for the duration of the COVID-19 public health emergency, to expand the availability […]
Presenting the Future of POC Hemostasis Diagnostics at ESA & ISTH SSC
Charlottesville, VA – May 24, 2018 – HemoSonics today announced it will be participating in the scientific proceedings as well as have a commercial presence at Euroanesthesia (ESA), to be held in Copenhagen, Denmark on June 2-4th. HemoSonics will be participating in the ESA’s pre-congress session on Point of Care Guided Haemostatic Management During Massive […]
Remi Corlin Leads International Commercial Rollout of Quantra® System
Following CE Mark in April, HemoSonics Targets Distribution Partners at MEDICA 2017 Charlottesville, VA – October 19, 2017 – HemoSonics today announced the appointment of Remi Corlin, a 20-year medical device and diagnostic industry veteran, as VP International Markets to lead the rollout of the Quantra Hemostasis Analyzer in markets outside of the US. The […]
Four Quantra Abstracts Presented at ISTH 2017
Charlottesville, VA – July 11, 2017 – HemoSonics today announced the presentation of scientific and clinical data at the XXVI International Society on Thrombosis and Hemostasis (ISTH) Congress in Berlin, Germany. These abstracts demonstrate the excellent analytical performance of the Quantra Surgical Cartridge with the Quantra™ Hemostasis Analyzer and its clinical utility in cardiac surgery and cancer patients. The data is being presented by Clinicians at the University of Virginia and associates at HemoSonics LLC. The ISTH conference is being held in Berlin, Germany, July 8-13, 2017.