clinical validation Articles
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Nanostics Re-Opens ClarityDX Prostate Clinical Study with New US Recruitment Site
Summary Nanostics' clinical validation study for ClarityDX Prostate, a liquid biopsy test for the early diagnosis of clinically significant prostate cancer, re-opens recruitment after lifting of COVID-19 research restrictions A top-ranked research institute in the Northeast US will now partner with Nanostics' by recruiting patients for the clinical validation study This partnership will ...
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The Benefits of Decentralized Clinical Trials for Neurology
The COVID-19 pandemic has catalyzed the implementation of decentralized clinical trials in neurology, bringing the immense benefits of clinical trials to light. This industry-wide push towards trial decentralization has emerged as a key element for improving clinical trial efficiency and improving the experience for patients and physicians. By utilizing digital technologies, such as wearables, ...
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Validation of a two-gene mRNA urine test for detection of high-grade prostate cancer in German men.
Organizations Martini-Klinik Prostate Cancer Center and Department of Urology, University Hospital Hamburg-Eppendorf, Hamburg, Germany, MDxHealth, B.V., Nijmegen, Netherlands, MDxHealth, Inc., Irvine, CA, Mathematical Modeling, Statistics and Bioinformatics, Ghent University, Ghent, Belgium, Martini-Klinik Prostate Cancer Center, University Hospital Hamburg-Eppendorf, Hamburg, Germany Abstract ...
By MDxHealth
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Bio-tech firm recruiting Yukon men for trial, Prostate cancer group says it could save lives
The Yukon chapter of Ride For Dad says a new blood test developed by an Alberta-based company could save the lives of men at risk of prostate cancer. (iStock/Getty Images) A bio-technology company based in Alberta is testing a new process that could result in fewer Yukon men travelling out of territory for prostate cancer biopsies. Private research company Nanostics Inc. and the University of ...
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Clinical validation of the Caregiver non-contact thermometer model PRO-TF300 in febrile and afebrile patients age 0 to < 18
Background: The CAREGIVER Thermometer Model PRO-TF300 (Thermomedics Inc., Delray Beach, FL) is a non-contact clinical professional thermometer used to read human body temperature in children and adults through the determination of infrared energy from the middle of the forehead. The purpose of this paper is to describe the methods and findings of the CAREGIVER’S validation for clinical use ...
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Clinical validation of the Caregiver non-contact thermometer model PRO-TF200/ PRO-TF300 in febrile and afebrile patients of all ages
Background. The CAREGIVER® Model PRO-TF200 and PRO-TF300 (Thermomedics, Miami, FL) are non-contact clinical professional thermometers used to read human body temperature in children and adults through the determination of infrared energy from the middle of the forehead. Both models function identically, thus they will be referred to hereafter as "CAREGIVER". The purpose of this paper is to ...
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Nanostics Announces Study Data Supporting ClarityDX Prostate as a Reflex Test to Predict Clinically Significant Prostate Cancer
Real-world data shows that at a 94% sensitivity level for prostate cancer ClarityDX Prostate® is 147% more specific than the PSA test for predicting clinically significant prostate cancer. Using ClarityDX Prostate® as a reflex test vs. PSA test alone could have resulted in 37% fewer unnecessary biopsies. The clinical study recruited men from two sites in Alberta, Canada, and one site ...
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IV safety valve dev Linear Health wins GCMI accelerator grant – Via MassDevice
Linear Health Sciences was featured in MassDevice focused on the GCMI/LHS Partnership Medical device accelerator the Global Center for Medical Innovation has issued its 1st grant to Linear Health Sciences, developer of the Orchid safety release valve designed to prevent dislodgment of IVs. The Oklahoma City-based company said it is developing safety release valves for a variety of medical ...
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Vectorious Begins the VECTOR-HF II Study of its Implantable In-Heart Sensor for Left Atrial Pressure-Guided Patient Self-Management of Heart Failure
For the first time, heart failure patients can have full visibility of their hearts’ LA pressure and self-adjust their medication to stop further deterioration and avoid hospitalizations April 26, 2022 08:30 AM Eastern Daylight Time TEL AVIV, Israel–(BUSINESS WIRE)–Vectorious Medical Technologies Ltd., today announced that it has enrolled the first six patients in the ...
By Vectorious
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Nanostics Receives CE Mark for its ClarityDX Prostate Test to Detect Clinically Significant Prostate Cancer
Nanostics’ biomarker and machine learning-powered test, ClarityDX Prostate®, received a CE-IVD Mark. A CE-IVD Mark is required for all in vitro diagnostic (IVD) devices to be placed in the European Economic Area, Iceland, Norway, and Liechtenstein and allows Nanostics to market and sell ClarityDX Prostate® in these countries. The ClarityDX Prostate® test provides patients ...
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Nanostics Announces the Launch of its Bladder Cancer Clinical Study Identifying Disease Predictors for Early Detection of Bladder Cancer
Clinical study launched in June 2022 with patient recruitment in Alberta with plans to expand to further sites across North America. The aim of the study is to validate a novel and minimally invasive liquid biopsy test for bladder cancer diagnosis using Nanostics’ ClarityDX® diagnostic platform. The study is supported in part by the Alberta Innovates AICE-Concepts Program with a ...
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A Novel, High-Throughput Platform to Characterize Novel IBD Therapeutics
Tumor Necrosis Factor Alpha (TNF-a) is a potent cytokine that is over-expressed by cells during chronic intestinal inflammation. Furthermore, TNF-a represents the most validated clinical target for ulcerative colitis (UC) and inflammatory bowel diseases (IBD) with multiple emerging neutralizing/inflammation-reducing therapeutics targeting this cytokine for inactivation. TNF-a activation of ...
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3 Things That Google’s Healthcare Artificial Intelligence Desperately Needs
Google DeepMind recently published a paper in Nature that shared how their predictive algorithm can detect Acute Kidney Injury (AKI) up to 48 hours in advance. Acute Kidney Injury is the biggest problem you have never heard of. In the US, 1 in 5 hospitalized adults gets Acute Kidney Injury, resulting in a 5x risk of death. It takes the lives of over 300,000 Americans every year. Globally, the ...
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Yaguo launches an Innovative Medical Device
At the beginning of Chinese New Year, Beijing Yaguo Technology Co., Ltd.'s innovative medical device "Respiratory Power" respiratory neuromuscular stimulator was officially launched. "Respiratory power" has been established in 2015 as a core innovative product of Yaguo, Through 4 years of continuously efforts, after research, demonstration, design, development, and clinical registration it has ...
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Plant-based cures for Vector-borne disease
Herb- and plant-based medicines have been used for as long as 60,000 years, with the first written record dating to 7,000 years ago. While these medicines have survived scientific evaluation with varying success, one in four medications currently used has a plant-based origin. One of the most successful medications treats a vector-borne disease. With all this history, why aren’t we ...
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A Conversation with Prof. Davide Capodanno, M.D., Ph.D. on the Landmark TAILOR-PCI Clinical Trial Results
After seven years and 5,300-patients tested, the results of the landmark TAILOR-PCI trial were announced in a virtual ACC session. This trial investigated whether a prospective approach using rapid on-site CYP2C19 testing could improve patient outcomes when selecting P2Y12 inhibitor therapy following PCI procedure. This is based on the well-established evidence that approximately 30-50% of ...
By Genomadix
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How to Measure Cognitive Decline In Older Patients
Primary care practitioners are often the first to address a patient’s or family’s concerns about memory loss or the possibility of dementia. Detecting cognitive decline as early as possible is fundamental to a patient’s ability to receive earlier access to treatments and therapies, and, consequently, more effective treatment and improved health outcomes. There are several ...
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Back to blog Federated Architecture in Genomics
Genome initiatives spearheaded by burgeoning numbers of data custodians such as Genomics England (GEL), a Lifebit customer, leverage technological advances to amass large volumes of patient data. As a result, data custodians are veritable gold mines of genome data that could transform precision medicine and provide an equitable solution for diverse healthcare requirements. Pharmaceutical ...
By Lifebit
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Signs of Parkinson’s Disease to Watch For
Parkinson’s disease is a progressive neurodegenerative disease that is most commonly known for affecting movement. It primarily impacts dopaminergic, or dopamine-producing, neurons in a specific area of the brain known as the substantia nigra. Typically, symptoms develop slowly over years and continue to worsen as the disease progresses. While the manifestation of symptoms tends to vary ...
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How Is Frontotemporal Dementia Different From Alzheimer`s?
People living with frontotemporal dementia, or FTD, are commonly misdiagnosed with psychiatric disorders or Alzheimer’s disease and other causes of dementia, such as Parkinson’s disease and vascular dementia. While frontotemporal dementia and Alzheimer’s disease can both cause dementia, there are distinct differences in impacted regions of the brain and, consequently, ...
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