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Sepsis Test Articles & Analysis

27 news found

CDRD Launches New Company Developing Life-Saving Sepsis Diagnostic

CDRD Launches New Company Developing Life-Saving Sepsis Diagnostic

The company is developing a novel rapid diagnostic test that will enable healthcare professionals to provide earlier and more targeted treatment of sepsis – a global healthcare problem that is more common than heart attack and claims more lives than any cancer. Infectious disease testing (including sepsis) is one of the ...

BySepset Biosciences Inc.


World Sepsis Day – Raising awareness about one of the most prevalent and deadly, yet misdiagnosed, medical conditions.

World Sepsis Day – Raising awareness about one of the most prevalent and deadly, yet misdiagnosed, medical conditions.

Sepset Biosciences is developing a novel rapid diagnostic test that will enable healthcare professionals to provide earlier and more targeted treatment of sepsis. ...

BySepset Biosciences Inc.


Bluejay Completes Planned Clinical Studies for Symphony IL-6 Test

Bluejay Completes Planned Clinical Studies for Symphony IL-6 Test

(NASDAQ: BJDX) (“Bluejay”, “the Company”), a medical diagnostics company focused on developing cost-effective, rapid, near-patient products for triage and monitoring of disease progression, today announced completion of its previously planned clinical studies for the Symphony IL-6 Test (the “Test”). Results of these studies ...

ByBluejay Diagnostics, Inc.


Bluejay Reports FDA Agrees to Consider its Plan to Pursue a De Novo Regulatory Pathway for the Symphony IL-6 Test

Bluejay Reports FDA Agrees to Consider its Plan to Pursue a De Novo Regulatory Pathway for the Symphony IL-6 Test

This confirms our belief that the Bluejay Symphony IL-6 Test has the potential to provide an innovative solution to the market. Bluejay continues to advance the Symphony IL-6 Test towards the Company’s anticipated marketing application with the FDA, expected by year-end ...

ByBluejay Diagnostics, Inc.


Bluejay Diagnostics Appoints Edwin Rule as Vice President, Regulatory, Quality and Compliance

Bluejay Diagnostics Appoints Edwin Rule as Vice President, Regulatory, Quality and Compliance

This user-friendly system is expected to fit into ICU/near-patient settings without the need for dedicated staff to run a test. The system has been designed to measure test analytes using whole blood. Samples are collected and loaded into proprietary, test-specific cartridges. The Symphony IL-6 Test is a development stage ...

ByBluejay Diagnostics, Inc.


Cytovale IntelliSep Test Demonstrates Potential to Rapidly Risk-Stratify Suspected COVID-19 Patients in New Study

Cytovale IntelliSep Test Demonstrates Potential to Rapidly Risk-Stratify Suspected COVID-19 Patients in New Study

“Data from this study published in PLOS ONE demonstrate the potential of the IntelliSep test to assist clinicians in the risk stratification and early direction of care for patients before the results of longer-lead time diagnostic tests are available. ...

ByCytovale Inc.


Cytovale Secures Additional BARDA Funding for 10-Minute IntelliSep Test for Sepsis

Cytovale Secures Additional BARDA Funding for 10-Minute IntelliSep Test for Sepsis

Cytovale, a medical diagnostics company focused on providing rapid and insightful tools to improve early detection of fast-moving and immune-mediated diseases, has received additional funding from Biomedical Research and Development Authority (BARDA) to help advance the company’s 10-minute IntelliSep sepsis risk stratification test towards commercial ...

ByCytovale Inc.


Magnolia Medical, MHA Solutions, and Healthcare Providers Insurance Company Enter into an Exclusive, Endorsed Agreement for the Steripath Initial Specimen Diversion Device

Magnolia Medical, MHA Solutions, and Healthcare Providers Insurance Company Enter into an Exclusive, Endorsed Agreement for the Steripath Initial Specimen Diversion Device

Magnolia Medical Technologies, Inc., inventors of Steripath®, the only FDA 510(k)-cleared device platform indicated to reduce blood culture contamination for sepsis testing,1 announced today that it has entered into an endorsed company agreement with MHA Solutions, a subsidiary of the Mississippi Hospital Association (MHA), and Healthcare Providers Insurance ...

ByMagnolia Medical Technologies


Members of Congress Urge CMS to Take Action to Reduce Preventable False-Positive Diagnostic Test Results for Sepsis

Members of Congress Urge CMS to Take Action to Reduce Preventable False-Positive Diagnostic Test Results for Sepsis

“By prioritizing the development and implementation of a specific quality measure for blood culture contamination and appropriately incentivizing the use of clinical practices and technologies that are proven to reduce (and nearly eliminate) contamination, CMS can directly and dramatically reduce the number of false positive blood tests for sepsis, one of ...

ByMagnolia Medical Technologies


Inflammatix Appoints Dr. Kian Beyzavi as New Board Member

Inflammatix Appoints Dr. Kian Beyzavi as New Board Member

The company’s initial focus is on acute infections and sepsis, where its tests combine proprietary biomarkers and advanced machine learning to help physicians quickly get the right treatments to the right patients. Future tests will be developed to run on the company’s sample-to-answer isothermal instrument platform in under 30 ...

ByInflammatix, Inc.


Inflammatix Announces Additional $12.1 Million Funding from BARDA for ViraBac EZ Acute Infection Test

Inflammatix Announces Additional $12.1 Million Funding from BARDA for ViraBac EZ Acute Infection Test

“With ViraBac EZ and all of our tests, we are integrating diverse patient cohorts in product development to ensure that our tests will perform in real-world practice across multiple clinical settings, from doctor’s offices and outpatient clinics to the emergency room. ...

ByInflammatix, Inc.


Magnolia Medical Announces Expansion of Its Extensive Clinical Evidence Library with Six Steripath® ISDD® Studies in 2021 Demonstrating Zero or Near-Zero False Positive Sepsis Test Results

Magnolia Medical Announces Expansion of Its Extensive Clinical Evidence Library with Six Steripath® ISDD® Studies in 2021 Demonstrating Zero or Near-Zero False Positive Sepsis Test Results

Magnolia Medical Technologies, Inc., inventors of Steripath®, the only FDA 510(k)-cleared device platform indicated to reduce blood culture contamination for sepsis testing,1 today announced that six studies, reporting zero or near-zero blood culture contamination rates and up to a 31% reduction in vancomycin days of therapy (DOT) using Steripath, were ...

ByMagnolia Medical Technologies


Inflammatix Awarded $1.7 Million Grant From National Institutes of Health (NIH)

Inflammatix Awarded $1.7 Million Grant From National Institutes of Health (NIH)

Severe COVID-19 is also a form of sepsis. “In sepsis, the body’s immune system becomes dysregulated and starts to damage the patient directly. ...

ByInflammatix, Inc.


Magnolia Medical Further Strengthens Executive Management Team with the Addition of Silicon Valley Financial Leader, Patrick O’Malley, as Chief Financial Officer

Magnolia Medical Further Strengthens Executive Management Team with the Addition of Silicon Valley Financial Leader, Patrick O’Malley, as Chief Financial Officer

Magnolia Medical Technologies, Inc., inventors of Steripath®, the only FDA 510(k)-cleared device platform indicated to reduce blood culture contamination for sepsis testing,1 today announced the expansion of its senior leadership team with the addition of Patrick O’Malley as Chief Financial Officer. ...

ByMagnolia Medical Technologies


Magnolia Medical Appoints Industry Veteran, Joseph Bishop, as the Senior Vice President of Operations and Product Development

Magnolia Medical Appoints Industry Veteran, Joseph Bishop, as the Senior Vice President of Operations and Product Development

Magnolia Medical Technologies, Inc., inventors of Steripath, the only FDA 510(k)-cleared device platform indicated to reduce blood culture contamination for sepsis testing,1 today announced the addition of Joseph Bishop to the executive leadership team as Senior Vice President of Operations and Product Development. ...

ByMagnolia Medical Technologies


New Study Supports Cytovale IntelliSep Test as Promising Tool to Aid in the Rapid Diagnosis of Sepsis in the Emergency Department

New Study Supports Cytovale IntelliSep Test as Promising Tool to Aid in the Rapid Diagnosis of Sepsis in the Emergency Department

Data from the study, “Assessment of a cellular host response test as a sepsis diagnostic for those with suspected infection in the Emergency Department,” showed that Cytovale’s test is a promising tool to aid in the rapid diagnosis and risk stratification for sepsis. ...

ByCytovale Inc.


Cytovale Begins Enrollment in FDA 510(k) Clinical Validation Study of IntelliSep Rapid Sepsis Test

Cytovale Begins Enrollment in FDA 510(k) Clinical Validation Study of IntelliSep Rapid Sepsis Test

The rapid test may aid hospital EDs in saving lives, preventing sepsis-related morbidity, and conserving resources for those who need it most. ...

ByCytovale Inc.


New Study Establishes Cytovale IntelliSep Test in the Rapid Diagnosis of Sepsis

New Study Establishes Cytovale IntelliSep Test in the Rapid Diagnosis of Sepsis

Data from the study, “Development and validation of a cellular host response test as an early diagnostic for sepsis,” showed that Cytovale’s test has the potential to provide clinically actionable performance in distinguishing potentially septic patients. ...

ByCytovale Inc.


Inflammatix Appoints Amy Boyle as Chief Operating Officer

Inflammatix Appoints Amy Boyle as Chief Operating Officer

” “This is an important stage of Inflammatix’s growth as the company advances its first product – the InSep acute infection and sepsis test – towards commercialization and continues development of its deep pipeline. I am excited to join Tim and our talented team as we unleash the power of immune-response testing to ...

ByInflammatix, Inc.


Inflammatix Secures $102 Million in Series D Financing Led by D1 Capital Partners to Commercialize Novel Host Response Diagnostics

Inflammatix Secures $102 Million in Series D Financing Led by D1 Capital Partners to Commercialize Novel Host Response Diagnostics

The tests are designed to be run on the company’s sample-to-answer, cartridge-based, point-of-care Myrna™ test system, which produces results in under 30 minutes. The funds will enable regulatory clearance and global commercialization of the Myrna system, and the InSep™ acute infection and sepsis test, which is ...

ByInflammatix, Inc.

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