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https://www.readbyqxmd.com/read/30107778/real-time-monitoring-of-pseudomonas-aeruginosa-biofilm-formation-on-endotracheal-tubes-in-vitro
#1
Eva Pericolini, Bruna Colombari, Gianmarco Ferretti, Ramona Iseppi, Andrea Ardizzoni, Massimo Girardis, Arianna Sala, Samuele Peppoloni, Elisabetta Blasi
BACKGROUND: Pseudomonas aeruginosa is an opportunistic bacterial pathogen responsible for both acute and chronic infections in humans. In particular, its ability to form biofilm, on biotic and abiotic surfaces, makes it particularly resistant to host's immune defenses and current antibiotic therapies as well. Innovative antimicrobial materials, like hydrogel, silver salts or nanoparticles have been used to cover new generation catheters with promising results. Nevertheless, biofilm remains a major health problem...
August 14, 2018: BMC Microbiology
https://www.readbyqxmd.com/read/30106644/21-st-century-citizen-pharma-the-fda-patient-focused-product-development
#2
Jordan Paradise
Perpetual debate regarding the delicate balance between access and innovation and the protection of the public health and safety dominate discussions of the United States Food and Drug Administration ("FDA"). Established chiefly as a command and control federal administrative agency, iterative changes in legislation have shaped the FDA's activity in drug, biologic, and medical device regulation over the course of the last one hundred plus years. The most recent fundamental reframing of the agency's authority and directive presented itself in the 21st Century Cures Act, reflecting an important role for patient perspectives in the regulatory process...
May 2018: American Journal of Law & Medicine
https://www.readbyqxmd.com/read/30099715/medical-device-patents-a-review-of-contemporary-global-trends-with-an-irish-comparison
#3
Roisin M O'Cearbhaill, Timothy E Murray, Michael J Lee
INTRODUCTION: Trends in medical technology patents provide an objective comparison of research and development between countries and over time. An analysis of these trends can benchmark innovation within Ireland in a worldwide context. By identifying and examining leading countries, domestic educational, infrastructural, regulatory and fiscal planning may be optimised. MATERIALS AND METHODS: Published data filing and granting reports from the two major patent offices (United States Patent and Trademark Office (USPTO) and European Patent Office (EPO)) were analysed...
August 11, 2018: Irish Journal of Medical Science
https://www.readbyqxmd.com/read/30099197/toxicological-assessment-of-additively-manufactured-methacrylates-for-medical-devices-in-dentistry
#4
Frank Alifui-Segbaya, Jasper Bowman, Alan R White, Sony Varma, Graham J Lieschke, Roy George
The paucity of information on the biological risks of photopolymers in additive manufacturing or three-dimensional printing (3DP) is a major challenge for the uptake of the technology in the construction of medical devices in dentistry. In this paper, the biocompatibility of additively manufactured methacrylates are evaluated using the innovative zebrafish (Danio rerio) embryo model. Data obtained confirmed gradations of toxicity primarily influenced by ethanol treatment, exposure scenarios, and extraction vehicles...
August 9, 2018: Acta Biomaterialia
https://www.readbyqxmd.com/read/30095337/the-efficacy-and-limits-of-magnetic-resonance-guided-focused-ultrasound-pallidotomy-for-parkinson-s-disease-a-phase-i-clinical-trial
#5
Na Young Jung, Chang Kyu Park, Minsoo Kim, Phil Hyu Lee, Young Ho Sohn, Jin Woo Chang
OBJECTIVE Recently, MR-guided focused ultrasound (MRgFUS) has emerged as an innovative treatment for numerous neurological disorders, including essential tremor, Parkinson's disease (PD), and some psychiatric disorders. Thus, clinical applications with this modality have been tried using various targets. The purpose of this study was to determine the feasibility, initial effectiveness, and potential side effects of unilateral MRgFUS pallidotomy for the treatment of parkinsonian dyskinesia. METHODS A prospective, nonrandomized, single-arm clinical trial was conducted between December 2013 and May 2016 at a single tertiary medical center...
August 10, 2018: Journal of Neurosurgery
https://www.readbyqxmd.com/read/30087093/technologies-for-innovative-monitoring-to-reduce-blood-pressure-and-change-lifestyle-using-mobile-phones-in-adult-and-elderly-populations-tim-study-protocol-for-a-randomized-controlled-trial
#6
Sandra C Fuchs, Erno Harzheim, Cirano Iochpe, Caroline N de David, Marcelo R Gonçalves, Guilhermo P Sesin, Cassio M Costa, Leila B Moreira, Flavio D Fuchs
BACKGROUND: Hypertension is a growing problem worldwide, markedly in low- and middle-income countries, where the rate of control slightly decreased. The overall prevalence of hypertension in Brazil is 28.7% among adult individuals and 68.9% in the population aged 60 years and older, and less than a third of patients have controlled blood pressure (BP). The use of technologies-mobile phones and the internet-to implement interventions to reduce blood pressure can minimize costs and diminish cardiovascular risk...
August 7, 2018: JMIR Research Protocols
https://www.readbyqxmd.com/read/30086592/-novel-minimally-invasive-treatment-options-for-male-lower-urinary-tract-symptoms
#7
Giuseppe Magistro, Thilo Westhofen, Christian Stief, Christian Gratzke
The main objective of novel minimally invasive treatment options is to be equally effective to current reference techniques while providing a superior safety profile. Especially the preservation of sexual function, including ejaculatory function, is of great interest to patients facing surgical treatment of lower urinary tract symptoms (LUTS). Ideally, a truly minimally invasive procedure can be performed under local anaesthesia in an outpatient setting. Among emerging medical devices, the prostatic urethral lift (PUL; Urolift) demonstrated rapid and durable relief of LUTS in selected patients without a prominent middle lobe...
August 2018: Aktuelle Urologie
https://www.readbyqxmd.com/read/30083806/a-comprehensive-framework-for-student-stress-monitoring-in-fog-cloud-iot-environment-m-health-perspective
#8
Prabal Verma, Sandeep K Sood
Over the last few years, Internet of Things (IoT) has opened the doors to innovations that facilitate interactions among things and humans. Focusing on healthcare domain, IoT devices such as medical sensors, visual sensors, cameras, and wireless sensor network are leading this evolutionary trend. In this direction, the paper proposes a novel, IoT-aware student-centric stress monitoring framework to predict student stress index at a particular context. Bayesian Belief Network (BBN) is used to classify the stress event as normal or abnormal using physiological readings collected from medical sensors at fog layer...
August 6, 2018: Medical & Biological Engineering & Computing
https://www.readbyqxmd.com/read/30079240/unintended-consequences-of-the-potential-phase-out-of-gamma-irradiation
#9
Jacquelyn W Chou, Michelle Skornicki, Joshua T Cohen
The radioisotope cobalt-60 (Co-60) is important for commercial, medical, and agricultural applications. Its widespread use has meant that Co-60 can be found in less secured facilities, leading to the fear that unauthorized persons could obtain and use it to produce a "dirty bomb". This potential security concern has led to government calls for phasing-out Co-60 and other radiation sources, despite ongoing safety and security regulations for handling, transport and use of radioactive sealed sources...
2018: F1000Research
https://www.readbyqxmd.com/read/30075936/-medical-devices-used-in-digestive-system-surgical-procedures-what-s-the-cost
#10
A Reiter-Schatz, P Bachellier, S Wisniewski, S Rohr, B Gourieux
OBJECTIVE: Medical devices innovations and associated procedures represent a large part of health facilities budget. The aim of this work was to evaluate the cost of medical devices used during different surgical procedures. This cost was compare with the revenue collected from hospital stay pricing. METHOD: A prospective analysis of the medical devices used in operating room was carried out for different types of programmed surgeries. For five weeks, references of sterile single-use medical devices used during the interventions were collected...
July 31, 2018: Annales Pharmaceutiques Françaises
https://www.readbyqxmd.com/read/30074133/patient-s-lived-experience-with-dbs-between-medical-research-and-care-some-legal-implications
#11
Sonia Desmoulin-Canselier
In the past 50 years, an ethical-legal boundary has been drawn between treatment and research. It is based on the reasoning that the two activities pursue different purposes. Treatment is aimed at achieving optimal therapeutic benefits for the individual patient, whereas the goal of scientific research is to increase knowledge, in the public interest. From this viewpoint, the patient's experience should be clearly distinguished from that of a participant in a clinical trial. On this premise, two parallel and mutually exclusive regimes have been established...
August 3, 2018: Medicine, Health Care, and Philosophy
https://www.readbyqxmd.com/read/30060963/tumor-treating-fields-in-combination-with-paclitaxel-in-recurrent-ovarian-carcinoma-results-of-the-innovate-pilot-study
#12
Ignace Vergote, Roger von Moos, Luis Manso, Els Van Nieuwenhuysen, Nicole Concin, Cristiana Sessa
BACKGROUND: Tumor Treating Fields (TTFields) are an anti-mitotic therapy comprising continuous delivery of low-intensity alternating electric fields at intermediate frequencies to the tumor region by a home-use medical device. METHODS: The INNOVATE (EF-22) Study was a phase 2, single arm clinical trial, which tested the safety and efficacy of TTFields (200 kHz) in combination with weekly paclitaxel (weekly for 8 weeks and then on days 1, 8, 15 of each subsequent 28 day-cycle; starting dose 80 mg/m2 ) in 31 patients with recurrent, platinum-resistant ovarian carcinoma...
July 27, 2018: Gynecologic Oncology
https://www.readbyqxmd.com/read/30057103/dressings-and-securements-for-the-prevention-of-peripheral-intravenous-catheter-failure-in-adults-save-a-pragmatic-randomised-controlled-superiority-trial
#13
Claire M Rickard, Nicole Marsh, Joan Webster, Naomi Runnegar, Emily Larsen, Matthew R McGrail, Fiona Fullerton, Emilie Bettington, Jennifer A Whitty, Md Abu Choudhury, Haitham Tuffaha, Amanda Corley, David J McMillan, John F Fraser, Andrea P Marshall, E Geoffrey Playford
BACKGROUND: Two billion peripheral intravenous catheters (PIVCs) are used globally each year, but optimal dressing and securement methods are not well established. We aimed to compare the efficacy and costs of three alternative approaches to standard non-bordered polyurethane dressings. METHODS: We did a pragmatic, randomised controlled, parallel-group superiority trial at two hospitals in Queensland, Australia. Eligible patients were aged 18 years or older and required PIVC insertion for clinical treatment, which was expected to be required for longer than 24 h...
August 4, 2018: Lancet
https://www.readbyqxmd.com/read/30052609/developing-an-in-house-interdisciplinary-three-dimensional-service-challenges-benefits-and-innovative-health-care-solutions
#14
Muhanad M Hatamleh, Juling Ong, Zaydoon Mohammad Hatamleh, Jason Watson, Chrisopher Huppa
Three-dimensional printing (3DP) technologies have been employed in regular medical specialties. They span wide scope of uses, from creating 3D medical models to design and manufacture of Patient-specific implants and guidance devices which help to optimize medical treatments, patient education, and medical training. This article aims to provide an in-depth analysis of factors and aspects to consider when planning to setup a 3D service within a hospital serving various medical specialties. It will also describe challenges that might affect 3D service development and sustainability and describe representative cases that highlight some of the innovative approaches that are possible with 3D technology...
July 26, 2018: Journal of Craniofacial Surgery
https://www.readbyqxmd.com/read/30025548/assessing-the-value-of-innovative-medical-devices-and-diagnostics-the-importance-of-clear-and-relevant-claims-of-benefit
#15
Bruce Campbell, Mark Campbell, Lee Dobson, Joanne Higgins, Bernice Dillon, Mirella Marlow, Chris J D Pomfrett
OBJECTIVES: Large numbers of new medical devices and diagnostics are developed and health services need to identify which ones offer real advantages. The National Institute for Health and Care Excellence (NICE) has introduced a system for assessing technologies that are often notified by companies, based on claims made for their benefits to patients, the National Health Service, and the environment. METHODS: Detailed scrutiny of claims made for the benefits of products and the corresponding evidence, seeking associations between these and the selection of products for full evaluation to produce NICE guidance...
July 20, 2018: International Journal of Technology Assessment in Health Care
https://www.readbyqxmd.com/read/30019884/medical-devices-immunology-and-microbiology-devices-classification-of-the-next-generation-sequencing-based-tumor-profiling-test-final-order
#16
(no author information available yet)
The Food and Drug Administration (FDA or we) is classifying the next generation sequencing based tumor profiling test into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the next generation sequencing based tumor profiling test's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device...
June 22, 2018: Federal Register
https://www.readbyqxmd.com/read/30019883/medical-devices-gastroenterology-urology-devices-classification-of-the-fluid-jet-system-for-prostate-tissue-removal-final-order
#17
(no author information available yet)
The Food and Drug Administration (FDA or we) is classifying the fluid jet system for prostate tissue removal into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the fluid jet system for prostate tissue removal's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device...
June 15, 2018: Federal Register
https://www.readbyqxmd.com/read/30019882/medical-devices-gastroenterology-urology-devices-classification-of-the-endoscopic-electrosurgical-clip-cutting-system-final-order
#18
(no author information available yet)
The Food and Drug Administration (FDA or we) is classifying the endoscopic electrosurgical clip cutting system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the endoscopic electrosurgical clip cutting system’s classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device...
June 14, 2018: Federal Register
https://www.readbyqxmd.com/read/30019881/medical-devices-immunology-and-microbiology-devices-classification-of-the-brain-trauma-assessment-test-final-order
#19
(no author information available yet)
The Food and Drug Administration (FDA or we) is classifying the brain trauma assessment test into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the brain trauma assessment test's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens...
June 14, 2018: Federal Register
https://www.readbyqxmd.com/read/30019874/medical-devices-orthopedic-devices-classification-of-the-in-vivo-cured-intramedullary-fixation-rod-final-order
#20
(no author information available yet)
The Food and Drug Administration (FDA or we) is classifying the in vivo cured intramedullary fixation rod into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the in vivo cured intramedullary fixation rod’s classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device...
June 8, 2018: Federal Register
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