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Hemodynamic Articles & Analysis
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Corify Care today announced a clinical milestone with two studies published in Heart Rhythm and Europace, validating its 4-D global cardiac mapping technology for atrial and ventricular arrhythmias in a single beat.Compared with conventional mapping, which often requires rhythm induction or dependence on pre-procedural imaging, the ACORYS mapping system captures global cardiac electrical activity ...
Phase III study FINE-ONE will evaluate the efficacy and safety of finerenone versus placebo in delaying the progression of chronic kidney disease (CKD) in adults with CKD and type 1 diabetes (T1D) CKD affects up to 40% of people with T1D A quarter of people with CKD associated with T1D progress to end-stage kidney disease Only limited treatment options are available for people with CKD and ...
ByBayer AG
Our latest publication in Cardiovascular Engineering and Technology showcases the feasibility and functionality of our VCAST technology, a patented, AI-based medical system developed for non-invasive, clinical quantitative and qualitative analysis of CT-scan data, to assess the hemodynamic significance of coronary artery atherosclerotic stenosis. Using a ...
European Commission granted approval for a label update to extend the indication of Kerendia™ to early stages of chronic kidney disease (CKD) associated with type 2 diabetes (T2D) and to include findings from the Phase III FIGARO-DKD cardiovascular (CV) outcomes study FIGARO-DKD included approximately 7,400 patients across a broad range of disease severity, including stages 1-4 CKD ...
ByBayer AG
CHMP opinion is based on the results from the Phase III FIGARO-DKD cardiovascular (CV) outcomes study in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D), which included approximately 7,400 patients across a broad range of disease severity, including stages 1-4 CKD associated with T2D The positive data from FIGARO-DKD demonstrated that finerenone significantly reduced the ...
ByBayer AG
Bodyport, a biomarker-guided digital therapeutics company on a mission to address complex chronic conditions, announced today the appointment of Jim Pursley to the company’s board of directors. “I am excited to join the Bodyport Board of Directors as they reimagine care for patients living with complex chronic conditions. Bodyport’s focus on the patient has driven them to ...
Daxor Corporation (Nasdaq: DXR), the global leader in blood volume measurement technology, today announces a new study in the prestigious Journal of Cardiac Failure demonstrating the importance and clinical utility of Daxor’s BVA-100 blood test in heart failure (HF). The researchers showed that Daxor’s BVA-100 was able to measure intravascular volume overload in heart failure ...
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 ...
New post-hoc analyses from the prespecified pooled analysis FIDELITY will provide insights into the effects of finerenone on kidney and cardiovascular outcomes by use of glucagon-like peptide-1 receptor agonists (GLP-1RA) at baseline, as well as by baseline HbA1c, HbA1c variability, and diabetes duration in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) An exploratory ...
ByBayer AG
Inari Medical, Inc. (NASDAQ: NARI) (“Inari”) a medical device company focused on developing products to treat and transform the lives of patients suffering from venous and other diseases, announced positive outcomes of the fully enrolled 800-patient FLASH registry in pulmonary embolism (“PE”). The data was presented during a Late-Breaking Clinical Trial session at the 2022 ...
The Cardiovascular Research Foundation (CRF) is pleased to announce that Puzzle Medical Devices Inc. has won the TCT 2022 Shark Tank Innovation Competition for its novel circulatory support device that is implanted percutaneously in the abdominal aorta. The competition took place during Transcatheter Cardiovascular Therapeutics (TCT), the world’s premier educational meeting specializing in ...
U.S. Food and Drug Administration (FDA) granted label update for Kerendia (finerenone) to include findings from the Phase III FIGARO-DKD cardiovascular (CV) outcomes study in patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) FIGARO-DKD investigated the efficacy and safety of finerenone versus placebo in addition to standard of care on the reduction of CV ...
ByBayer AG
Inari Medical, Inc. (NASDAQ: NARI) (“Inari”) a medical device company focused on developing products to treat and transform the lives of patients suffering from venous and other diseases, announced three new data sets will be presented during Late-Breaking Clinical Trial sessions at the 2022 TCT (Transcatheter Cardiovascular Therapeutics) and the 2022 VEINS (Venous Endovascular ...
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 ...
Bodyport, a digital therapeutics company on a mission to address complex chronic conditions, announced today that its noninvasive biomarker platform, the Bodyport Cardiac Scale™ received U.S. Food & Drug Administration (FDA) 510(k) clearance. This innovative solution enables people with fluid management conditions, such as heart failure and kidney disease, to noninvasively assess ...
Bodyport, a medtech company based in San Francisco, developed the Bodyport Cardiac Scale, a set of weighing scales that can non-invasively assess fluid status and heart function. The scales can detect these signals through the feet when a patient steps onto the device. The technology is intended to be convenient and requires only 20 seconds each morning, and should easily lend itself to ...
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 ...
Despite available treatment options, many patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) are progressing to kidney failure and premature death Kerendia (finerenone) is the first non-steroidal, selective mineralocorticoid receptor (MR) antagonist to demonstrate positive kidney and cardiovascular (CV) outcomes in patients with CKD associated with T2D The approval in China ...
ByBayer AG
Bodyport, a biomarker-guided digital therapeutics company on a mission to address complex chronic conditions, today announced the appointment of medtech industry veteran, John Lipman, as Chief Executive Officer. Bodyport co-founder, Corey Centen, will continue as President and also serve as Chief Technology Officer (CTO) of the company. Lipman’s appointment comes as Bodyport prepares for ...
Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), today announced positive data from the SIRONA 2 clinical trial evaluating safety and efficacy of its Cordella™ Pulmonary Artery Pressure Sensor System (Cordella Sensor) in New York Heart Association (NYHA) class III heart failure patients. The prospective, ...