clinically validated Articles
-
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 ...
-
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, ...
-
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
-
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 ...
-
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 ...
-
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 ...
-
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 ...
-
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 ...
-
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 ...
-
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
-
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 ...
-
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 ...
-
NO2 Sterilization as Part of a Batch Release Process for Clinical Trials
The nitrogen dioxide (NO2) sterilization process is an ideal candidate for the sterilization of the external, gas-accessible surfaces of prefilled syringes. A process has been designed to accommodate temperature and pressure-sensitive products such as drugs or biologics in prefilled syringes. The NO2sterilization process is applied to the prefilled syringes (or other containers) with minimal ...
-
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 ...
-
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 ...
-
The latest developments of Medis QFR
December 2022 edition Given the regular posts of peer-reviewed scientific publications on the Medis QFR®, it is clear that this angio-based solution for coronary physiology is extensively used in clinical research and practice. We would like to share these publications with you so that you remain up to date about the research that is ongoing worldwide with this innovative solution, ...
-
Three generations of ADC: Nearly a decade of development-PI
Antibody-drug conjugate (ADC), a compound that connects a cytotoxic small-molecule drug to a monoclonal antibody via a rationally established linker, which selectively delivers an efficient cytotoxic agent into the tumor, has made significant progress in the previous decade. The first ADC drug approved by the US FDA was gemtuzumab ozogamicin (Mylotarg) in 2009. Currently, the FDA has authorized ...
-
The evolution of photoplethysmography (PPG) within smart devices
As a technology, photoplethysmography (PPG) has been explored for almost a century, but it is only in the last few years that it has had a broader application beyond specialised medical settings. That has generally been driven by the evolution of smartphones, smartwatches and even smaller wearable devices such as smart rings. PPG is most commonly used in pulse oximetry in clinical settings ...
By Sky Labs
-
Reconstruction of tissues affected by Pilonidal Sinus Disease
Highlights • AROA’s Myriad Matrix™ is further validated in a clinical study and peer-reviewed publication in Journal of Wound Care. • Study of six patients shows 100% success rates from use of Myriad Matrix™ as an implant during surgical reconstruction of soft tissues affected by Pilonidal Sinus Disease (PSD). • All patients healed well with no major complications ...
-
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 ...
Need help finding the right suppliers? Try XPRT Sourcing. Let the XPRTs do the work for you