medical evaluation News
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EC and SCENIHR Begin Public Consultation on Preliminary Opinion on Guidance on the Determination of Potential Health Effects of Nanomaterials Used in Medical Devices
The European Commission (EC) and the Scientific Committee on Emerging Newly Identified Health Risks (SCENIHR) have begun a public consultation on the preliminary opinion concerning “Guidance on the Determination of Potential Health Effects of Nanomaterials Used in Medical Devices.” The aim of the opinion is to address the use of nanomaterials in medical devices and to provide ...
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CCRO Conducts First Clinical Trial with Head and Neck Surgery
Jeremy Richmon, MD is leading a new clinical trial sponsored by Alume, the Center for Clinical Research Operations' (CCRO) first clinical trial with Head and Neck Surgery. The trial involves using a tracer to help identify nerves intraoperatively. This type of cutting edge translational surgical innovation improves outcomes and ultimately the lives of our patients. The amount of coordination and ...
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Noleus Wins Audience Choice at MedTech Innovator Pitch Event
Noleus Technologies won the audience choice award at the MedTech Innovator Houston Pitch Event. The event was hosted at the Johnson and Johnson Innovation JLABS@TMC event space. According to the MedTech Innovator website, these events "feature pitches from best-in-class medical device, diagnostic, and digital health companies vying for a spot in the 2018 program." Judging from local experts in ...
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STEPS Budapest Center for Robotic Rehabilitation to Install deXtreme 3.1 for Commercial Evaluation
BioXtreme is proud to announce that a new commercial evaluation agreement was signed with STEPS Budapest Center for Robotic Rehabilitation. The agreement includes a 6- months evaluation period for deXtreme, by the end of which STEPS commits to purchasing the device (pending evaluation criteria are met). BioXtreme has developed a ground-breaking robotic device for motor-learning, based on ...
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Medisculpt by Biotec Italia, the state-of-the-art technology for muscle toning and body sculpting
Are you looking for innovative, painless but above all fast techniques to reshape your silhouette? Then Medisculpt by Biotec Italia is the solution for you. We know…getting a lean, reshaped physique requires a combination of healthy diet with years of exercise. Leading a healthy lifestyle is about feeling good about yourself, reducing your risk of disease (and so much more). However, ...
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Illinois Same-Day Surgery Centers under the Spotlight
Earlier this month, the Northwest Herald reported about the state of infection control at same-day surgical centers across Illinois. According to the article, of the surgery centers inspected in the past year, 2/3 had been cited for infection control problems. News of these infection control problems coincide with a new federal report that was just released that shows an increase in ...
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back to overview Help for clinics, nursing services and medical practices
sfm medical devices in Wächtersbach wants to support the supply of protective masks (MNS masks and FFP2) sfm medical devices, a medium-sized med-tech company based in Wächtersbach, sees itself as responsible for providing support in the currently tense procurement situation for protective masks. At the end of March, a concept was developed in collaboration with the company's Medical ...
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First-in-Human Trial Evaluates Safety and Efficacy of Rex Medical`s Large Bore Closer System
November 7, 2018 — At VIVA 2018, the Vascular Interventional Advances annual conference held November 5–8 in Las Vegas, Nevada, Micah Watts, MD, presented findings from the first-in-human clinical trial of the Large Bore Closer vascular sealing system (Rex Medical). The trial evaluated 23 patients at a single site and assessed the safety and effectiveness of the Large Bore Closer ...
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STEMart Launches Pyrogenicity Testing Service for Medical Devices
STEMart, a provider of integrated medical device CRO services dedicated to medical device and diagnostic clinical development, now launches Pyrogenicity Testing service for the medical device industry. This new testing follows the biocompatibility guidelines modified for medical devices. Due to the risks associated with medical devices, comprehensive medical device testing throughout the product ...
By STEMart
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Flosonics Medical’s FloPatch selected by OBIO as one of the first eight Early Adopter Health Network innovation projects
The company is collaborating with the Ontario Bioscience Innovation Organization (OBIO) to evaluate its core technology at Health Sciences North in Greater Sudbury Flosonics Medical’s wireless, wearable Doppler ultrasound system was selected as one of the first eight Early Adopter Health Network (EAHN) innovation projects by the Ontario Bioscience Innovation Organization (OBIO). As part ...
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InspireMD Receives Reimbursement Approval for CGuard™ Embolic Prevention System from the French National Authority for Health
InspireMD, Inc. (Nasdaq: NSPR), a global developer of the CGuard™ Embolic Prevention Stent System (EPS) device for the treatment of Carotid Artery Disease (CAD) and stroke prevention, today announced that its CGuard EPS stent system has received a positive opinion from the National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDIMTS) of the French National ...
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STEMart Launches New Force Degradation Services to Ensure Drug Stability and Safety
STEMart, a US-based provider of comprehensive services for all phases of medical device development, announced the launch of its new Force Degradation Services to help pharmaceutical and medical device companies evaluate the stability of their drug candidates and finished products under a variety of stress conditions, ensuring their safety and efficacy throughout their shelf life. Forced ...
By STEMart
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Daxor Corporation Receives National Institutes of Health (NIH) Funding Notification for Landmark Multi-Center Heart Failure Trial Utilizing the BVA-100® (Blood Volume Analyzer) with the United States Department of Veterans Affairs
Daxor Corporation (NYSE MKT: DXR), the global leader in blood volume measurement technology, today announces the initiation of a multi-center clinical trial with two Veterans Affairs Medical Centers to evaluate Blood Volume Analysis guided management of acute decompensated heart failure (ADHF) utilizing the BVA-100 blood test. Over 6 million Americans suffer from heart failure, one of the most ...
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NeuroOne Reports Second Quarter Fiscal Year 2022 Financial Results and Provides Corporate Update
NeuroOne Medical Technologies Corporation (NASDAQ: NMTC) ("NeuroOne" or the "Company"), a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, today announces its operating results for the second quarter of fiscal year 2022 ended March 31, 2022. Second Quarter and Recent Business Updates Evo® sEEG electrode ...
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Nucleix Presents Clinical Data at EAU21 Virtual Congress Which Demonstrates Promising Advances in the Care of Bladder Cancer Patients
SAN DIEGO & REHOVOT, ISRAEL--(BUSINESS WIRE)--Nucleix, a liquid biopsy company revolutionizing cancer treatment by detecting the disease earlier, today announced data from two abstracts featuring its Bladder EpiCheck® test at the 36th Annual European Association of Urology (EAU) Virtual Congress. The first abstract titled, “Real world evidence of alternating cystoscopy/cytology ...
By Nucleix Ltd.
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CoapTech LLC Awarded $1.2M Grant from National Institutes of Health to Support Clinical Evaluation and Training for Novel PUMA-G Device
CoapTech LLC announced today that the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) within the National Institutes of Health (NIH) awarded the company a two-year, $1.2M R44 Small Business Innovation Research (SBIR) Phase II grant on August 29, 2019. This builds on a $225,000 Phase I SBIR R43 grant and a $200,000 Maryland Industrial Partnerships (MIPS) grant awarded to ...
By CoapTech
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AventaMed selected as Test Case for RWE by NESTcc
The National Evaluation System for health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium (MDIC), announces twelve new Test-Cases which leverage Real-World Evidence (RWE) and address key priorities for medical device stakeholders. These Test-Cases are intended to accelerate NESTcc’s progress and provide proof of concept for NESTcc’s ...
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iRhythm listed among Medtech Big 100 for second year in a row
iRhythm is included in the Medtech Big 100, a ranking of the world’s largest medical device companies, for the second year in a row. Medical Design & Outsourcing says it evaluates companies for the list based on annual revenue, research and development spending, number of employees, key leaders, headquarters locations, and company descriptions. Read the profile for iRhythm and see the ...
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ASTM D5151 - 06(2011) Standard Test Method for Detection of Holes in Medical Gloves
This test method is designed to detect holes that leak water and thereby compromise the usefulness of the glove. This test method is suitable and designed as a reference method to evaluate samples of medical gloves. 1. Scope 1.1 This test method covers the detection of holes in medical gloves. 1.2 This test method is limited to the detection of holes that allow water leakage under the ...
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STEMart Introduces Biocompatibility Evaluation of Breathing Gas Pathways in Medical Devices
STEMart, a provider of integrated medical device CRO services dedicated to medical device and diagnostic clinical development, expands its Biocompatibility Testing services and introduces biocompatibility evaluation of breathing gas pathways in medical devices. This new testing follows the biocompatibility guidelines modified for medical devices and uses a solid scientific rationale. ...
By STEMart
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