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HemoSonics

hemosonics.com ↗ · Southeast

FDA-cleared device company

Profile checked Oct 10, 2026

Keywords: Coagulation Surgical Blood Loss Blood Loss Massive Trauma Coagulation Disorder Post Partum Hemorrhage Pediatric Obstetric Hemostasis Post Operative Hemorrhage Blood Loss Thrombosis Pediatric ALL Hemorrhage Liver Transplant Cardiovascular Diseases COVID Disseminated Intravascular Coagulation Postpartum Hemorrhage Cardiac Surgery Quantra System Diagnostic Test: Quantra QStat Cartridge Diagnostic Test

26Trials (company is sponsor)1FDA records (2 yrs)

Timeline

  1. Trial start —: Quantra QPlus in Pediatric Cardiovascular Procedures source ↗
  2. Trial start —: Reference Range Study for the Quantra System With the QPlus Cartridge in Pediatric Patients source ↗
  3. FDA FDA 510(k) clearance: Quantra QStat Cartridge — K251404, Aug 25, 2025. Applicant at approval: Hemosonics, LLC. source ↗
  4. Grant Government grant: $525,000 (total, as published), announced Oct 21, 2024. Source: company's own press page. source ↗
  5. Trial start —: QStat Cartridge in Obstetric Patients source ↗
  6. Trial start —: Reference Range Study for the Quantra System With the QStat Cartridge in Obstetric Patients source ↗
  7. Trial start —: Quantra QStat Sample Type Comparison source ↗
  8. Trial start —: Evaluation of the Quantra QStat System in Obstetric Patients source ↗
  9. Trial start —: QPlus Pediatric Reference Interval source ↗
  10. Trial start —: Exploratory Assessment of the Quantra® System in Adult ECMO Patients source ↗
  11. Trial start —: Quantra® System With the QStat® Cartridge in Trauma source ↗
  12. Trial start —: Quantra QPlus Sample Type Comparison source ↗
  13. Trial start —: Use of the Quantra QPlus Sytem in Cardiac Surgery source ↗
  14. Trial start —: Coagulation Changes Associated With COVID-19 Infection source ↗
  15. Trial start —: Quantra QStat in Trauma and Liver Transplant source ↗
  16. Trial start —: Reference Range Study for the Quantra QStat System source ↗
  17. Trial start —: QStat in Trauma and Obstetric Hemorrhage source ↗
  18. Trial start —: QStat in Liver Transplant source ↗
  19. Trial start —: Evaluation of the Quantra System in a Surgical Oncological Population source ↗
  20. Trial start —: HemoSonics - UTMB Cardiac Surgery Study source ↗
  21. Trial start —: Evaluation of the Clinical Performance of the Quantra System With the QStat Cartridge in Trauma source ↗
  22. Trial start —: Pre-surgical Evaluation for the Quantra System in Adult Patients Undergoing Cardiac Surgery source ↗
  23. Trial start —: Evaluation of the Clinical Performance of the Quantra System With the QStat Cartridge source ↗
  24. Trial start —: QStat Pilot Reference Range Study source ↗
  25. Trial start —: Comparison of Two Point-of-care Devices for Viscoelastic Hemostasis Assays source ↗

Showing 25 of 28 dated events.

Upcoming milestones

Estimated primary completion per ClinicalTrials.gov. Dates move.

Funding

Last 2 years.

Clinical trials (lead sponsor) 26

RecordTitlePhaseStatusStartPrimary completion
NCT07447713Reference Range Study for the Quantra System With the QPlus Cartridge in Pediatric PatientsNot listedNot yet recruitingMar 15, 2027Jan 30, 2028 (estimated)
NCT07597278Quantra QPlus in Pediatric Cardiovascular ProceduresNot listedNot yet recruitingJun 25, 2027Jun 1, 2028 (estimated)
NCT06255496QStat Cartridge in Obstetric PatientsNot listedCompletedMay 9, 2024Aug 15, 2025 (actual)
NCT06415760Reference Range Study for the Quantra System With the QStat Cartridge in Obstetric PatientsNot listedCompletedMay 7, 2024Apr 1, 2025 (actual)
NCT05376462Quantra® System With the QStat® Cartridge in TraumaNot listedTerminatedApr 12, 2022Jan 1, 2024 (actual)
NCT05875987Evaluation of the Quantra QStat System in Obstetric PatientsNot listedCompletedJun 1, 2023Mar 31, 2024 (actual)
NCT06025708Quantra QStat Sample Type ComparisonNot listedCompletedSep 11, 2023Jan 5, 2024 (actual)
NCT05426564Exploratory Assessment of the Quantra® System in Adult ECMO PatientsNot listedCompletedSep 27, 2022May 17, 2023 (actual)
NCT05645133QPlus Pediatric Reference IntervalNot listedTerminatedFeb 27, 2023Jun 1, 2023 (actual)
NCT04312958Quantra QStat in Trauma and Liver TransplantNot listedCompletedJul 20, 2020Dec 31, 2022 (actual)
NCT05290675Quantra QPlus Sample Type ComparisonNot listedCompletedNov 4, 2021Aug 31, 2022 (actual)
NCT05501730Use of the Quantra QPlus Sytem in Cardiac SurgeryNot listedCompletedJun 15, 2021Nov 21, 2021 (actual)
NCT04460664Coagulation Changes Associated With COVID-19 InfectionNot listedCompletedAug 14, 2020Apr 28, 2021 (actual)
NCT04114253QStat in Liver TransplantNot listedCompletedSep 4, 2019Aug 12, 2020 (actual)
NCT04385953QStat in Trauma and Obstetric HemorrhageNot listedCompletedDec 10, 2019Jul 1, 2020 (actual)
NCT04116385Evaluation of the Quantra System in a Surgical Oncological PopulationNot listedCompletedAug 15, 2019Mar 12, 2020 (actual)
NCT04490759QStat Pilot Reference Range StudyNot listedCompletedNov 29, 2018Dec 4, 2018 (actual)
NCT04219371Reference Range Study for the Quantra QStat SystemNot listedCompletedJan 7, 2020Apr 17, 2020 (actual)
NCT03931031Pre-surgical Evaluation for the Quantra System in Adult Patients Undergoing Cardiac SurgeryNot listedCompletedMar 21, 2019Apr 7, 2020 (actual)
NCT03988465HemoSonics - UTMB Cardiac Surgery StudyNot listedCompletedJun 19, 2019Mar 13, 2020 (actual)
NCT03934983Evaluation of the Clinical Performance of the Quantra System With the QStat Cartridge in TraumaNot listedCompletedMar 28, 2019Jan 29, 2020 (actual)
NCT03912545Evaluation of the Clinical Performance of the Quantra System With the QStat CartridgeNot listedCompletedMar 4, 2019Jul 11, 2019 (actual)
NCT03685097Comparison of Two Point-of-care Devices for Viscoelastic Hemostasis AssaysNot listedCompletedMar 1, 2018Jul 31, 2018 (actual)
NCT03152461Evaluation of the Clinical Performance of the Quantra System With the Quantra Surgical CartridgeNot listedCompletedMay 23, 2017Feb 9, 2018 (actual)
NCT03139097Reference Range Study for the Quantra Analyzer With the Quantra Surgical CartridgeNot listedCompletedJan 16, 2017Sep 28, 2017 (actual)
NCT02978872Quantra Determination of Coagulation Parameters in Arterial and Venous BloodNot listedCompleted2016-072017-01 (actual)

FDA records (last 2 years)

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