kidney function News
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Osprey Medical Receives US FDA Clearance for DyeVert™ Plus
Osprey Medical (ASX:OSP) today announced that it has received US FDA 510(k) clearance for its advanced DyeVert™ PLUS Contrast Reduction System. This new platform augments Osprey’s current technology with the capability to actively manage dye administration during coronary interventions. DyeVert PLUS received European CE Mark in 4Q 2016. The company further validated its dye savings ...
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New independent market research says 84% US healthcare professionals likely to use Orviglance imaging agent in target population
Ascelia Pharma today announced and welcomed the results of independent market research showing that 84% of healthcare professionals will likely use Orviglance for magnetic resonance imaging (MRI) in patients with cancer in the liver and reduced kidney function. The independently conducted survey asked 270 healthcare professionals in the US (radiologists, oncologists and nephrologists) about ...
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Results from Orviglance comparison study to gadolinium presented at RSNA 2021
Ascelia Pharma AB (publ) (ticker: ACE) today presented results at the world’s largest radiology conference, RSNA, in Chicago, Illinois from the study in which the investigational contrast agent Orviglance® was compared against a gadolinium-based contrast agent. As communicated earlier, the comparison study versus the gadolinium contrast agent showed that MRI enhanced with the ...
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Osprey Introduces DyeVert PLUS at TCT
Osprey Medical (ASX:OSP) is pleased to announce the expansion of its portfolio with introduction of the DyeVert™ PLUS Contrast Modulation/Monitoring System. This new platform integrates the current DyeVert technology with substantial patient management and monitoring capabilities. The system has received European CE Mark and FDA clearance is pending. The Company anticipates US availability ...
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DyeVert Pilot Trial Results Presented at EuroPCR
Osprey Medical Inc. (ASX: OSP) is pleased to announce the results of the DyeVert Pilot Trial as presented at the European Association of Percutaneous Cardiovascular Intervention’s annual conference (EuroPCR) during May 19th in Paris, France. The results from the clinical trial were presented to one of the world’s largest international conferences in the area of cardiovascular medicine ...
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GE Healthcare to Distribute Osprey Medical’s Technology to Address Angiography Based Acute Kidney Injury (AKI)
GE Healthcare and Osprey Medical Inc. (ASX:OSP) (Osprey) today announced a strategic alliance under which GE Healthcare will exclusively distribute Osprey’s product portfolio in Europe, Russia, Middle East, Africa, Central Asia and Turkey. Osprey’s DyeVert™ contrast minimization devices, complemented by GE Healthcare's range of iodinated x-ray contrast media, offer healthcare ...
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Puzzle Medical to Present at TCT 2022 Its First-in-Human Study Results for the ModulHeart™
Montreal-based Puzzle Medical Devices Inc. (PMD) developed a percutaneous heart pump designed to support cardiac and renal function in patients with advanced heart failure (HF). PMD announced it will present its first-in-human results for the ModulHeartTM in the following session during the Transcatheter Cardiovascular Therapeutics (TCT) meeting held September 16-19, 2022 at the Boston Convention ...
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Procyrion Raises $30 Million Series D to Support Clinical Trials of Its Aortix™ Percutaneous Blood Pump for Treating Heart Failure Patients
Procyrion, Inc., a clinical-stage medical device company, today announced the completion of a $30 million Series D funding round led by a new investor, Bluebird Ventures. Returning investors include Fannin Partners, Scientific Health Development, the State of Texas, and an undisclosed strategic investor. The company is developing its Aortix™ system, a percutaneous blood pump initially ...
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Dicerna Presents PHYOX™2 and Primary Hyperoxaluria Healthcare Utilization Data at American Society of Nephrology (ASN) Kidney Week 2021
Dicerna Pharmaceuticals, Inc. (Nasdaq: DRNA), a leading developer of investigational ribonucleic acid interference (RNAi) therapeutics, today announced results of the PHYOX™2 pivotal clinical trial of nedosiran, an investigational GalXC™ RNAi candidate for the treatment of primary hyperoxaluria (PH), in a late-breaker poster presentation at the American Society of Nephrology (ASN) ...
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Puzzle Medical to Present at AHA 2022 its First-in-Human Study Results
Puzzle Medical Devices Inc. is delighted to announce its first-in-human results for the ModulHeart have been presented at the prestigious American Heart Association (AHA) meeting held November 5–7, 2022 at the McCormick Place Convention Center in Chicago, IL. Montreal-based Puzzle Medical Devices Inc. (PMD) developed a percutaneous heart pump designed to support cardiac and renal function ...
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BenevolentAI and AstraZeneca achieve collaboration milestone with novel AI-generated chronic kidney disease target
BenevolentAI today announced that the biopharmaceutical company AstraZeneca has selected a novel chronic kidney disease (CKD) target to advance to its drug development portfolio, making it the first AI-generated target from the collaboration to enter the Company’s portfolio. Novel chronic kidney disease (CKD) target from the partnership enters AstraZeneca’s portfolio AI-generated ...
By Benevolent
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Procyrion Names AV Edidin, Ph.D., as Senior Vice President of Development and Manufacturing
Procyrion, Inc., a clinical-stage medical device company developing the Aortix™ system, a percutaneous blood pump initially targeted for treating patients with heart failure and worsening kidney function (cardiorenal syndrome), announced the appointment of Av Edidin, Ph.D., as Senior Vice President of Development and Manufacturing. In this role, Edidin will lead and oversee product ...
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Ascelia Pharma successfully completes Orviglance Hepatic Impairment Study
Ascelia Pharma AB (publ) (ticker: ACE) today announced that the last patient visit has been completed in the clinical study to evaluate the effect of liver impairment on the safety, pharmacokinetics and pharmacodynamics of the company’s lead drug candidate Orviglance. Preliminary results show that Orviglance was well tolerated in patients with liver impairment. The study is part of the ...
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Puzzle Medical Announces the Successful Completion of its First-in-Human Study with its ModulHeart
Montreal-based Puzzle Medical Devices Inc., announced today the successful completion of the company’s ?rst-in-human study to evaluate the performance of its ModulHeart percutaneous heart pump designed to reduce cardiac afterload and improve renal perfusion in patients with advanced heart failure (HF). Four patients had ModulHeart deployed to provide circulatory support while undergoing ...
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Aurinia Presents Results from the Two-Year AURORA 2 Continuation Study at the 2022 European Renal Association (ERA) Congress
Use of LUPKYNIS was safe and well tolerated in patients for up to three years of treatment, with no new safety signals In AURORA 2, long-term treatment with LUPKYNIS led to a clinically relevant preservation of kidney function in LN patients A pooled analysis from the AURA-LV and AURORA 1 studies, also presented at ERA, showed early treatment response to LUPKYNIS with reductions in ...
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CO2 whenever possible: the Malaysian experience
Congrats to Dr. Ismazizi B. Zaharudin and to the team of Kuala Lumpur National Heart Center – Institut Jantung Negara – for choosing CO2 as a #first contrast agent, saving the renal function of their patients. Amazing job with 40 patients treated in just a few weeks! #angiodroid #theCO2injector #ACDA #academy #CO2angiography #CO2 #procedure #zerocontrast #angiography ...
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Vertex Advances VX-147 Into Pivotal Clinical Development for People With APOL1-Mediated Kidney Disease
Single pivotal trial to initiate later this month targets the broad patient population with two APOL1 mutations and proteinuric kidney disease Pathway for accelerated approval using an interim analysis at Week 48 of eGFR slope, supported by reduction in proteinuria Final analysis evaluating eGFR slope at approximately two years serves as basis for U.S. approval Vertex Pharmaceuticals ...
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Health & Wellness: What Urinalysis Could Say About Your Well-being
Most people would agree that only looking at your bank account once a year is a bad idea, yet when we look at our own health, the only data many of us collect is from a once-a-year checkup, in which doctors will run a series of laboratory tests. These tests are a single data point describing the very dynamic systems that are our bodies, which change throughout the year. In order to start ...
By Fluxergy
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Nova Blood Gas Analyzers Add Important New Test: Mean Corpuscular Hemoglobin Concentration (MCHC)
Waltham, MA - Nova Biomedical announces the addition of another important critical care parameter to its Stat Profile Prime Plus blood gas analyzer—the ability to rapidly calculate and report mean corpuscular hemoglobin concentration (MCHC). MCHC is a measure of the hemoglobin concentration in a given volume of packed red blood cells. MCHC, along with measured hemoglobin and ...
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Bayer extends clinical development program for finerenone with Phase III study in children and adolescents with chronic kidney disease
For children and adolescents with chronic kidney disease (CKD), as for adults, the unmet need is high for new treatments to delay disease progression and preserve kidney function / The Phase III study FIONA will investigate the effect of finerenone in pediatric patients with CKD and severely increased proteinuria Bayer announced today the initiation of the FIONA study, a multicenter, randomized, ...
By Bayer AG
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