clinical assessment News
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Vestech works with Urucu to establish clinical trials
Urucu, a Brazilian natural therapy, has been launched in Australia as a skin moisturizer. Vestech is assisting IPS, the makers of Urucu, with developing a clinical trial strategy to assess the validity of a number of therapeutic claims made for this compound in ...
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German Federal Ministry of Education and Research („BMBF“) selects tiakis Biotech AG to develop Tiprelestat as a potential therapeutic for COVID-19.
tiakis Biotech AG (formerly Proteo Biotech AG) has announced that the German BMBF has selected the Company to conduct a clinical phase 1b/2 trial to develop its investigational medical product Tiprelestat as a potential therapeutic for COVID-19. The aim of the clinical trial is to assess Tiprelestat’s efficacy to attenuate severe disease progression of COVID-19. The Company expects the ...
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BrainScope Surpasses Primary Endpoints in Multi-Year Department of Defense-Funded Validation Study for New Concussion Assessment Capability
BrainScope announced today that it has successfully completed a nearly five year, $9.9 million U.S. Department of Defense research contract supporting the development and validation of an objective marker of the presence and severity of concussion. In a large blinded validation study, the system demonstrated its ability to help clinicians assess concussion at the time of injury, reflect severity ...
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Study confirms Digitsole’s PODOSmart is a valid tool for gait analysis compared to the gold standard Vicon motion system?
A study published in the September 2021 issue of Sensors, titled A Novel Tool for Gait Analysis: Validation Study of the Smart Insole PODOSmart® concluded that Digitsole’s PODOSmart® is a valid tool for gait analysis compared to the gold standard Vicon motion system. The study also concluded that because PODOSmart® is a portable gait analysis tool with an affordable ...
By Digitsole
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Digitsole Pro® is FDA Registered Class II - Innovative AI-Based Solution for Clinical Assessment of Mobility Disorders
Digitsole, a leader in the digital health space bringing together digital mobility biomarkers and biomechanical data with clinical expertise, has received Class II medical device registration with the U.S. Food and Drug Administration (FDA) for its Digitsole Pro® smart insoles. Digitsole Pro®, recently launched in the United States, is a solution, developed with, and for ...
By Digitsole
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SIGA Provides Update on Progress in Clinical Trials to Assess Use of TPOXX ® (tecovirimat) for Treatment of Monkeypox
NEW YORK, Oct. 12, 2022 (GLOBE NEWSWIRE) -- SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a commercial-stage pharmaceutical company focused on the health security market, today provided an update on the status of multiple clinical trials now underway to assess the safety and efficacy of TPOXX to treat monkeypox. In recent weeks, randomized, placebo-controlled clinical trials were initiated in ...
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Clinical investigations
We performed 2 clinical trials in leading neurorehabilitation hospitals in Germany and Spain proving safety, feasibility and usability of the exoskeleton in a clinical setting, and showing significant improvements in clinical outcomes and benefits in rehabilitation. A Multicentric Clinical investigation in Institut Guttmann (Spain) and Heidelberg University Hospital (Germany), leading European ...
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Lipella Pharmaceuticals Initiates its Phase-2a Clinical Trial of LP-10 for Hemorrhagic Cystitis
A multi-site, prospective, open-label, dose-escalation clinical trial assessing the safety and efficacy of LP-10 (liposomal tacrolimus) is now open for recruitment at several sites. PITTSBURGH, October 15, 2020 (BUSINESS WIRE) – Lipella Pharmaceuticals Inc., a clinical-stage pharmaceutical company focused on improving cancer survivorship, today announced it has begun recruiting patients in ...
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JAMA Highlights Success of BrainScope`s EEG-based Concussion Index As Reliable Indicator of Concussion
JAMA Network Open has published "Validation of a Machine Learning Brain Electrical Activity-Based Index to Aid in Diagnosing Concussion Among Athletes," a ground-breaking study on the accuracy of the BrainScope FDA-cleared biomarker, the Concussion Index, to indicate the likelihood and severity of concussive brain injury and to aid in evaluating an athlete's readiness to return to play. "What ...
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Balt Completes Enrollment in FIRST: A Multi-center, Prospective, International Study of Low Profile Silk Vista Flow Diverters
Balt, an innovative neurovascular company focused on developing, designing, and manufacturing solutions for treating complex, life-threatening conditions, including stroke, aneurysms, and arteriovenous malformations, today announced enrollment in the FIRST study has been completed. The FIRST study is an observational, prospective, multi-center, international, single-arm study with the aim of ...
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Mauna Kea Technologies Participates in Dutch Molecular Imaging Consortium that was Awarded €5.4 Million
MEDPHOT consortium aims to develop light-based molecular imaging solution for pulmonary diseases Mauna Kea Technologies today announced it is part of a molecular imaging consortium that was awarded €5.4 million by the Perspective Program of the Netherlands Organization for Scientific Research (NWO). Molecular imaging provides insight into molecular and cellular processes in the body, and ...
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BillionToOne to present series of single-gene NIPT posters at 2020 ACMG Annual Clinical Genetics Meeting
BillionToOne, a venture-backed precision diagnostics company, is presenting series of posters at 2020 ACMG Annual Clinical Genetics Meeting on its single-gene NIPT technology and clinical data. UNITY improves clinical specificity for cystic fibrosis carrier screening UNITY is the only prenatal screen that tests cell-free fetal DNA for cystic fibrosis, spinal muscular atrophy (SMA), sickle cell ...
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Radiotherapy That Could Halve Prostate Cancer Treatment Time Recommended For Use in Wales
Health Technology Wales (HTW) has published guidance recommending the routine adoption of Extreme Hypofractionated Radiotherapy (EHFRT) for the treatment of localised prostate. In the UK, prostate cancer is the most common cancer in men and in Wales, more than 2,500 men each year are diagnosed with prostate cancer. Radiotherapy is included as part of primary treatment in approximately 30% of ...
By MediWales
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£1.1 million project to develop new biodegradable stents
A £1.1 million project to develop biodegradable stents for patients with severe vascular disease, which affects around one million people in the UK, has started thanks to Innovate UK funding. The unique project, a collaboration between the UK-based medical device company Arterius and the Translational Biomedical Research Centre (TBRC) at the University of Bristol, will develop a new type of ...
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Medinol Completes Enrollment of EluNIR-HBR Study
May 2020, Tel-Aviv, Israel – Medinol announces completion of enrollment in its EluNIR HIGH BLEEDING RISK (HBR) trial. A prospective, multi-center, single-arm, open-label post marketing clinical trial, to assess the safety and efficacy of the EluNIR Drug Eluting Stent (DES) in combination with shortened DAPT duration, in patients undergoing PCI who are considered to be at high bleeding ...
By Medinol
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FARAPULSE’s Pivotal Trial to Assess Its Leading Pulsed Field Ablation System for The Treatment of Atrial Fibrillation Receives FDA Conditional Approval
FARAPULSE Inc. (“FARAPULSE” or “the Company”) today announced the U.S. Food and Drug Administration (FDA) conditionally approved the Company’s Investigational Device Exemption (IDE) application to initiate its U.S. pivotal ADVENT trial to evaluate the safety and effectiveness of its Pulsed Field Ablation (PFA) system for the treatment of paroxysmal Atrial ...
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Lead in Kids’ Blood Linked With Behavioral and Emotional Problems
Emotional and behavioral problems show up even with low exposure to lead, and as blood lead levels increase in children, so do the problems, according to research funded by the National Institute of Environmental Health Sciences (NIEHS), part of the National Institutes of Health. The results were published online June 30 in the journal JAMA Pediatrics. "This research focused on lower blood lead ...
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Avelas Welcomes Susan Stimson to its Board of Directors
SAN DIEGO, November 22, 2019 – Avelas Biosciences, Inc., a clinical-stage oncology company developing AVB-620 for real-time cancer detection is pleased to announced the addition of Susan Stimson as a Director of the company. “Susan brings an exceptional background and skillset to the Avelas Board. She has had incredible success throughout her career and her knowledge and experiences ...
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Avelas Biosciences Presents Phase II, Period 1 Data in Poster Session at San Antonio Breast Cancer Symposium
SAN DIEGO, December 4, 2018 – Avelas Biosciences, Inc., a clinical-stage oncology company developing AVB-620 for real-time cancer detection, presented the initial results of the first part of its Phase II clinical trial in a poster session at this week’s San Antonio Breast Cancer Symposium (SABCS). The poster, titled “Use of a fluorescent activatable cell penetrating peptide ...
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William T. Abraham, MD, Joins V-Wave as Chief Medical Officer
V-Wave Ltd., an early stage medtech company developing an implantable interatrial shunt device for treating advanced heart failure (HF) and pulmonary arterial hypertension (PAH), announced today that renowned heart failure cardiologist, William T. Abraham, MD, is joining V-Wave as Chief Medical Officer. Dr. Abraham makes this move to V-Wave after more than 16 years as Director of the Division of ...
By V-Wave Ltd.
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