Clinical Testing News
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Koning Begins FDA Clinical Screening Trial in Daytona Beach, Florida
DAYTONA BEACH, Fla., Nov. 1, 2021 /PRNewswire/ -- Koning begins an FDA screening trial this month for their no-compression, Isotropic, 3-dimensional breast imaging device. The company received FDA PMA approval for commercial, diagnostic use in 2017. Since then, the Koning Breast CT (KBCT) has been installed in clinics and universities in the US and globally. "This FDA screening trial is a major ...
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STEMart Announces Pilot Production Services for Medical Devices
STEMart, a US-based provider of comprehensive services for all phases of medical device development, is proud to announce the launch of its new Pilot Production Services for the medical device industry. These services allow manufacturers to test and refine their products prior to full-scale production, streamlining the development process of new medical devices and minimizing risk to save time ...
By STEMart
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Synaptive Medical Welcomes Chris Marrus as New Chief Commercial Officer
Synaptive Medical Inc., a global med tech and technology company solving surgical, imaging and data challenges, is proud to announce the appointment of Chris Marrus as Chief Commercial Officer. This appointment underscores Synaptive’s commitment to driving sales, expanding its market presence, and advancing innovative solutions in imaging and surgical technology focused on combining the ...
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New cohort study shows use of Synaptive’s robotic exoscope improves clinical outcomes in spine surgery
A new cohort study published in World Neurosurgery by the Neurosurgery Department at Medical University of South Carolina (MUSC) examined the use of the Synaptive Modus exoscope (n=123) versus a microscope (n=123) in spine surgery. The use of the exoscope resulted in shorter operative time, reduced blood loss, shorter length of stay and favorable clinical outcomes compared to the use of the ...
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HighRun DataScience Propels Retail Businesses With Advanced Data Analytics
HighRun DataScience, a leading provider of data science solutions, has recently announced the launch of its comprehensive suite of statistical and data science services specifically designed to empower retail businesses of all sizes. Leveraging advanced technologies and a team of expert data scientists, HighRun DataScience empowers retailers to unlock actionable insights from their data, optimize ...
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Optimizing Monoclonal Antibody Production: Temperature And Osmolality’s Impact, Upcoming Webinar Hosted By Xtalks
In this free webinar sponsored by Advanced Instruments, gain insights into advances in monoclonal antibody production technology and manufacturing strategies. Attendees will learn why temperature and osmolality in cell culture are critical parameters affecting cell growth, viability and the concentration of HCPs in the supernatant. The featured speaker will discuss how temperature and osmolality ...
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Caresyntax Announces Launch of Novel Real World Evidence (RWE) Program and Software Portfolio of Digital Catalysts for Commercial Acceleration of Medtech Partners
Caresyntax, the leading vendor-neutral surgical data and intelligence platform converging AI-powered software, devices, and clinical services, today announced the launch of Caresyntax Clinical Data as a Service (CDaaS) for Medtech industry partners. The launch of Caresyntax CDaaS follows the recently announced addition of CQInsights (CQI) and appointment of Dr. Bruce Ramshaw as Chief Medical ...
By Caresyntax
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Tris Pharma Partners with Perigon Pharmacy 360 to Enhance Access to DYANAVEL® XR Tablets for the Treatment of Attention Deficit Hyperactivity Disorder
Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company focused on attention deficit hyperactivity disorder (ADHD), pain, addiction and neurological disorders, today announced a new partnership with Perigon Pharmacy 360, a full-service, specialty digital pharmacy, to enhance accessibility, affordability and adherence for patients treating symptoms of ADHD with Tris’ ...
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Vitalograph expands Clinical Trial services portfolio with centralized DLCO, decentralized spirometry, and integrated oscillometry solutions.
With more than 60 years’ expertise in respiratory diagnostics, Vitalograph is the only company in the world specialized in delivering clinical trial services exclusively for pulmonary function-focused studies. Speaking about the recent additions to their portfolio of services, Richard James, Executive Vice President and Chief Operating Officer of Vitalograph Clinical Trials says: ...
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CD Genomics Revolutionizes Pathogen Discovery with the Launch of Viral Metagenomic Sequencing Service
CD Genomics, a global leader in genomic and bioinformatics solutions, is pleased to announce the official launch of its Viral Metagenomic Sequencing service. This state-of-the-art offering represents a major advancement in the field of pathogen research and promises to provide unparalleled insights into viral communities. Viruses, being the most abundant entities on our planet, play a pivotal ...
By CD Genomics
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CD Formulation Empowers High-volume Manufacturing of Microspheres
Over the past decade, innovation in the field of microsphere production has reached new heights. Thanks to groundbreaking technology, CD Formulation has enabled mass production services for these versatile particles. Through a cutting-edge approach, CD Formulation is well-prepared to serve the industry by offering efficient and effective solutions for the mass fabrication of microspheres. From ...
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FREE Webinar – QCS Audit Masterclass: How to use audit effectively
Would you like to achieve good governance in your service through demonstrating continuous quality improvement? Join our next webinar 'QCS Audit Masterclass: How to use audit effectively' Date: 7th September Time: 1:00pm - 2:00pm To achieve good governance in your service you must demonstrate continuous quality improvement. Auditing and documenting the effectiveness of the processes and ...
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Creative Proteomics Introduces Innovative Absolute Quantification (AQUA) Service for Precise Protein Quantification Analysis
Creative Proteomics, a leading global provider of proteomics services, is proud to announce the launch of its innovative Absolute Quantification (AQUA) service, offering scientists a highly accurate solution for protein quantification analysis. This groundbreaking service will play a crucial role in life science research, drug development, and clinical diagnostics. Absolute Quantification (AQUA) ...
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Vitalograph introduces tremoflo C-100 oscillometer to its extensive range of respiratory diagnostic solutions
Vitalograph, a global leader in the development and production of respiratory diagnostic solutions and clinical trial services, has launched the Vitalograph tremoflo® C-100 at this year’s ATS International Conference, in Washington. Developed in partnership with Thorasys, the Vitalograph tremoflo® C-100 oscillometer helps to detect the presence of small airway impairment, providing ...
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Vitalograph introduces tremoflo C-100 oscillometer to its extensive range of respiratory diagnostic solutions
Vitalograph, a global leader in the development and production of respiratory diagnostic solutions and clinical trial services, has launched the Vitalograph tremoflo® C-100 at this year’s ATS International Conference, taking place in Washington. ...
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Bayer receives U.S. FDA Fast Track Designation for asundexian atrial fibrillation program
The OCEANIC-AF (atrial fibrillation) study with asundexian is part of the Phase III OCEANIC clinical trial program enrolling more than 27,000 patients in over 40 countries Asundexian is being evaluated as a potential improved treatment option in stroke prevention and could be part of an entirely new class of treatment options in thrombosis management that aims to uncouple efficacy from ...
By Bayer AG
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Tris Pharma Expands Leadership Team as Company Broadens Commercial Portfolio and Progresses Clinical Pipeline
Thomas Englese, a 20+ year industry veteran with a track record of success at leading biopharmaceutical companies, joins as chief commercial officer Marc Lesnick, Ph.D., appointed as chief development officer, bringing more than 20 years of experience in multiple therapeutic areas Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company focused on ADHD, pain and neurological ...
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New data from pivotal studies with aflibercept 8 mg
New Subgroup and further analyses from PULSAR, PHOTON and CANDELA provide insights into durability results of extended treatment intervals, patient characteristics as well as efficacy and safety of intravitreal aflibercept 8 mg In total, 18 presentations on aflibercept 8 mg and Eylea (aflibercept 2 mg) reinforce Bayer’s commitment to advancing treatment of patients with exudative retinal ...
By Bayer AG
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Bayer expands global clinical program for darolutamide in prostate cancer
Phase III study ARASTEP initiated in hormone-sensitive prostate cancer, in patients with high-risk biochemical recurrence (BCR) who have no evidence of metastatic disease by conventional imaging and a positive PSMA PET CT at baseline Fifth major clinical trial for androgen receptor inhibitor (ARi) darolutamide, covering prostate cancer from early to metastatic stage Bayer further expands ...
By Bayer AG
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New Study Confirms Daxor’s BVA-100 Volume Metric Compared to CardioMEMS Pressure Metric Has Unique Clinical Utility as a Diagnostic for Heart Failure Patients
Daxor Corporation (NYSE: DXR), the global leader in blood volume measurement technology, today announces new data validating the benefits of the Company’s BVA-100 diagnostic in optimizing individualized therapy for heart failure patients. Data were presented at the Technology Heart Failure Therapeutics Conference, which focuses on device and technology-based treatments in heart failure. ...
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