sepsis test News
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Study Demonstrates Substantial Cost Savings in Health Economic Model of the Inflammatix Host-Response Test for Sepsis
Inflammatix, a pioneering molecular diagnostics company delivering precision medicine at the point of care, announced the publication of a health economic model that shows use of the company’s HostDxTM Sepsis test in patients suspected of acute respiratory tract infections (ARTI) in Emergency Departments is cost-effective versus standard-of-care. The study was published today in The Journal ...
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Members of Congress Urge CMS to Take Action to Reduce Preventable False-Positive Diagnostic Test Results for Sepsis
Magnolia Medical Technologies, Inc., inventors of Steripath®, the only FDA 510(k)-cleared device platform indicated to reduce blood culture contamination for sepsis testing1, commended U.S. Representatives Mike Levin (D-CA), Gus Bilirakis (R-FL), and eight of their colleagues for sending a joint, bipartisan letter urging the Centers for Medicare and Medicaid Services (CMS), an agency within ...
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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. Mr. Bishop brings extensive and diverse medical device experience to Magnolia ...
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Abionic Successfully Raises CHF20 Million in Series C Financing
Abionic SA, a developer of disruptive nanotechnology based rapid diagnostic solutions, announced today the successful closing of a CHF20 million Series C financing. The round was led by Pierangelo Bottinelli, Chairman of Symphony International Holdings Limited, and included Philippe Glatz (Chairman of two private hospitals), Peter Brabeck-Letmathe (former CEO and Chairman of Nestlé), ...
By Abionic SA
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Inflammatix Appoints Amy Boyle as Chief Operating Officer
Inflammatix, a pioneering molecular diagnostics company, announced today the appointment of experienced medical device executive Amy Boyle as Chief Operating Officer, effective April 5, 2021. Ms. Boyle brings 30 years of broad commercial medical device experience to the company, with expertise in strategy, market development, sales and marketing, commercial operations, and manufacturing. Most ...
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Abionic: International Pivotal Study Successfully Demonstrates Diagnosis of Sepsis within 5 Minutes – 24 Hours Earlier Compared with Current Standard-of-Care
Abionic SA, a developer of disruptive nanotechnology based rapid diagnostic solutions, announced today the successful completion of its multi-center observational study using Abionic’s novel point-of-care Pancreatic Stone Protein (PSP) sepsis test on the abioSCOPE® platform. The results of the study show an anticipation of 24 hours for the diagnosis of sepsis compared to current ...
By Abionic SA
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Cytovale Begins Enrollment in FDA 510(k) Clinical Validation Study of IntelliSep Rapid Sepsis Test
Cytovale, a medical diagnostics company focused on providing a faster, more insightful way to diagnose fast-moving and immune-mediated diseases, today announced the first enrollment in a clinical trial of the Cytovale system and IntelliSep test to aid in the rapid assessment of potential for sepsis in the emergency department (ED). The trial, A Clinical Validation Solving the Question of ...
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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 launch. This latest contract action, ...
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Inflammatix Secures $102 Million in Series D Financing Led by D1 Capital Partners to Commercialize Novel Host Response Diagnostics
Inflammatix, a pioneering molecular diagnostics company, announced today the closing of a $102 million Series D round of financing to support development and commercialization of its novel immune response diagnostics portfolio. D1 Capital Partners led the round, with participation from the company’s existing investors, including Northpond Ventures, Khosla Ventures, Think.Health, and OSF ...
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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. Mr. O’Malley is a seasoned public company executive bringing over three decades ...
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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 (HPIC), a reciprocal insurer that ...
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Inflammatix Awarded $1.7 Million Grant From National Institutes of Health (NIH)
Inflammatix, a pioneering molecular diagnostics company, announced today that the National Institute of General Medical Sciences, part of the National Institutes of Health, has awarded the company a Small Business Innovation Research (NIH SBIR) Direct-to-Phase II grant of $1.7 million. The funding will be used to develop a rapid diagnostic that will identify immune subtypes ...
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Bluejay Reports FDA Agrees to Consider its Plan to Pursue a De Novo Regulatory Pathway for the Symphony IL-6 Test
Bluejay Diagnostics, Inc. (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 that the FDA has agreed to consider Bluejay’s plan to pursue a De Novo submission for the Symphony IL-6 Test. In written feedback to the ...
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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 submitted, accepted and published in ...
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Inflammatix Appoints Dr. Kian Beyzavi as New Board Member
Inflammatix, a pioneering molecular diagnostics company, announced today the appointment of Kian Beyzavi, PhD, as an independent member of the company’s board of directors. Dr. Beyzavi is a seasoned veteran of the healthcare industry with significant operating experience in the medical device and diagnostics industries, and a focus on leveraging innovative technologies to improve diagnosis ...
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Inflammatix Announces $32 Million in Series C Funding
Financing will be used to advance HostDx tests for acute infections and sepsis to commercial launch in 2021. Inflammatix, a pioneering molecular diagnostics company delivering precision medicine at the point of care, today announced a $32 million Series C financing. The funding round included participation from existing investors Khosla Ventures, Northpond Ventures and Think.Health Ventures, and ...
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New Study Supports Cytovale IntelliSep Test as Promising Tool to Aid in the Rapid Diagnosis of Sepsis in the Emergency Department
Cytovale, a medical diagnostics company focused on providing a more rapid and insightful way to diagnose fast-moving and immune mediated diseases, today announced the publication of a study in the peer-reviewed journal Critical Care Explorations (CCE) evaluating its IntelliSep test as a tool in the rapid diagnosis of sepsis in the hospital emergency department (ED). Data from the study, ...
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World Sepsis Day – Raising awareness about one of the most prevalent and deadly, yet misdiagnosed, medical conditions.
Sepsis is the body’s over active and toxic response to an infection that causes hospitalization of more than 18 million people around the world every year, including 30,000 Canadians Declared a Global Health Priority by the World Health Organization in 2017 80% of sepsis deaths in hospitals could be prevented with rapid diagnosis and treatment Vancouver, Canada: Noting World Sepsis ...
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Bluejay Completes Planned Clinical Studies for Symphony IL-6 Test
Bluejay Diagnostics, Inc. (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 will be ...
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CDRD Launches New Company Developing Life-Saving Sepsis Diagnostic
Marking “World Sepsis Day”, The Centre for Drug Research and Development (CDRD) announces the spin-off of a new company, Sepset Biosciences Inc. 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 ...
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