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Innovative medical devices

U Rajendra Acharya, Yuki Hagiwara, Hojjat Adeli
In the past two decades, significant advances have been made on automated electroencephalogram (EEG)-based diagnosis of epilepsy and seizure detection. A number of innovative algorithms have been introduced that can aid in epilepsy diagnosis with a high degree of accuracy. In recent years, the frontiers of computational epilepsy research have moved to seizure prediction, a more challenging problem. While antiepileptic medication can result in complete seizure freedom in many patients with epilepsy, up to one-third of patients living with epilepsy will have medically intractable epilepsy, where medications reduce seizure frequency but do not completely control seizures...
October 11, 2018: Epilepsy & Behavior: E&B
Adrian Thorogood, Seydina B Touré, Johan Ordish, Alison Hall, Bartha Knoppers
This article provides a primer on medical device regulations in the United States, Europe, and Canada. Software tools are being developed and shared globally to enhance the accessibility and usefulness of genomic databases. Interactive software tools, such as email or mobile alert systems providing variant classification updates, are opportunities to democratize access to genomic data beyond laboratories and clinicians. Uncertainty over the reliability of outputs, however, raises concerns about potential harms to patients, especially where software is accessible to lay users...
November 2018: Human Mutation
Raghavendra Nayak, Ratan K Banik
Peripheral nerve stimulation has been used in the treatment of several chronic pain conditions including pain due to peripheral nerve dysfunctions, complex regional pain syndrome, and cranial neuralgias. It has been shown to be effective for chronic, intractable pain that is refractory to conventional therapies such as physical therapy, medications, transcutaneous electrical stimulations, and nerve blocks. Recently, a new generation of peripheral nerve stimulation devices has been developed; these allow external pulse generators to transmit impulses wirelessly to the implanted electrode, and their implantation is significantly less invasive...
2018: Pain Research and Treatment
David Y Ming, George L Jackson, Jessica Sperling, Megan Gray, Noelle Wyman Roth, Tracy Spears, Victoria Parente, Hayden Bosworth
Care plans can reduce care fragmentation for children with medical complexity (CMC); however, implementation is challenging. Mobile health innovations could improve implementation. This mixed methods study's objectives were to (1) evaluate feasibility of mobile complex care plans (MCCPs) for CMC enrolled in a complex care program and (2) study MCCPs' impact on parent engagement, parent experience, and care coordination. MCCPs were individualized, updated quarterly, integrated within the electronic health record, and visible on parents' mobile devices via an online portal...
October 7, 2018: Clinical Pediatrics
Victoria A Hampshire, Samuel H Gilbert
The U.S. Food and Drug Administration Center for Devices and Radiological Health (FDA/CDRH) has recently published several in vivo test guidance documents that mention refinements, reductions, or replacement animal testing strategies to facilitate the leveraging of data from large animal safety tests for conventional rodent testing. In response to the recently enacted Food and Drug Administration Safety and Innovation Act Section 907, which facilitates expedited access to novel therapies commonly described as Breakthrough Therapy Designation, FDA/CDRH has discussed efficient regulatory strategies for first-in-human investigation, including early feasibility study guidance...
October 1, 2018: Toxicologic Pathology
Chia-Chang Chuang, Jiann-Yeou Rau, Men-Kuan Lai, Chung-Liang Shih
OBJECTIVE: Strong earthquakes often cause massive structural and nonstructural damage, timely assessment of the catastrophe related massive casualty incidents (MCIs) for deploying rescue resource are critical in order to minimize ongoing fatalities. A magnitude 6.6 earthquake struck southern Taiwan on February 6, 2016 (the so-called 02/06 Meinong earthquake). It led to 117 deaths and 522 injuries. Advanced technologies including aerial devices and innovation concept were adopted for more effective rescue efforts...
September 27, 2018: Prehospital Emergency Care
Humair A Siddiqui, Kim L Pickering, Michael R Mucalo
Biomedical materials constitute a vast scientific research field, which is devoted to producing medical devices which aid in enhancing human life. In this field, there is an enormous demand for long-lasting implants and bone substitutes that avoid rejection issues whilst providing favourable bioactivity, osteoconductivity and robust mechanical properties. Hydroxyapatite (HAp)-based biomaterials possess a close chemical resemblance to the mineral phase of bone, which give rise to their excellent biocompatibility, so allowing for them to serve the purpose of a bone-substituting and osteoconductive scaffold...
September 24, 2018: Materials
Eoin White, Muireann McMahon, Michael Walsh, J Calvin Coffey, Leon Walsh, Dara Walsh, Leonard O'Sullivan
PURPOSE: There is a paucity of methods to model soft anatomical tissues. Accurate modelling of these tissues can be difficult with current medical imaging technology. METHODS: The aim of this research was to develop a methodology to model non-intestinal colorectal tissues that are not readily identifiable radiologically to enhance contextual understanding of these tissues and inform medical device design. The models created were used to inform the design of a novel medical device to separate the mesocolon from the retroperitoneum during resection of the colon...
September 22, 2018: International Journal of Computer Assisted Radiology and Surgery
Yu Mi Wi, Robin Patel
Treatment of medical device-related infections is challenging and recurrence is common. The main reason for this is that microorganisms adhere to the surfaces of medical devices and enter into a biofilm state in which they display distinct growth rates, structural features, and protection from antimicrobial agents and host immune mechanisms compared with their planktonic counterparts. This article reviews how microorganisms form biofilms and the mechanisms of protection against antimicrobial agents and the host immune system provided by biofilms...
September 18, 2018: Infectious Disease Clinics of North America
Christina Wilson, Rachel Lukowicz, Stefan Merchant, Helena Valquier-Flynn, Jeniffer Caballero, Jasmin Sandoval, Macduff Okuom, Christopher Huber, Tessa Durham Brooks, Erin Wilson, Barbara Clement, Christopher D Wentworth, Andrea E Holmes
Biofilms are microbial communities attached to a surface and embedded in an extracellular polymeric substance which provides for the protection, stability and nutrients of the various bacterial species indwelling. These communities can build up in a variety of different environments from industrial equipment to medical devices resulting in damage, loss of productivity and disease. They also have great potential for economic and societal benefits as bioremediation agents and renewable energy sources. The great potential benefits and threats of biofilms has encouraged researchers across disciplines to study biofilm characteristics and antibiofilm strategies resulting in chemists, physicists, material scientists, and engineers, to develop beneficial biofilm applications and prevention methods...
December 2017: Research & reviews. Journal of engineering and technology
Davida A Robinson, Jessie H Evans, Angelo J Martellaro, Carl A Johnson, Jude S Sauer, Peter A Knight
Focused research targeting an identified clinical problem may result in more rapid development of medical devices, technologies, and surgical techniques that directly impact patient care. These medical advances to improve patient care may be expedited by adopting an interactive translational research model in which inventors, designers, and engineers work in collaboration with surgeons. In addition, cadaveric simulation is a high-fidelity model that is bridging the translational and logistical gap to bring new surgical devices, technologies, and techniques to patients...
August 2018: Annals of Translational Medicine
Raven Voora, Alan L Hinderliter
PURPOSE OF REVIEW: To review the role and evidence for sympathetic overactivity in resistant hypertension and review the therapies that have been studied to modulate the sympathetic nervous system to treat resistant hypertension, with a focus on non-pharmacologic therapies such as renal denervation, baroreflex activation therapy, and carotid body ablation. RECENT FINDINGS: Based on the two best current techniques available for assessing sympathetic nerve activity, resistant hypertension is characterized by increased sympathetic nerve activity...
September 7, 2018: Current Hypertension Reports
F Hulstaert, L Verleye, J Harrison, H Nevens, F Vrijens, M Devis, G Briat, K Rondia
Many questions in healthcare can only be answered after the conduct of clinical trials. For medicinal products and medical devices the industry finances most studies to bring their products to market. However, there is a need for further research in certain areas e.g. children, older people and comparative research of different treatment options (comparative effectiveness). In addition, interventions that are less industry-driven such as surgery, radiotherapy, psychotherapy, diet, physical medicine, needappropriately funded large scale clinical trials...
September 2018: Revue Médicale de Liège
Ernst Klar
The main goal of the Medical Device Regulation (MDR) is the improvement of patient safety by laying down rules concerning the approval of medical devices for human use in the European Union. The MDR contains an extension of the conformity assessment procedure for products in the higher risk categories IIb and III. The clinical testing and assessment are regulated more strictly by e.g. the scrutiny process conducted by expert panels following the technical certification. The demand for documentation is vastly increasing due to more detailed registration (UDI) and an extension of post-market surveillance...
October 2018: Der Chirurg; Zeitschrift Für Alle Gebiete der Operativen Medizen
Martyn F Biddiscombe, Omar S Usmani
Inhaled medication is the cornerstone in the treatment of patients across a spectrum of respiratory diseases including asthma and chronic obstructive pulmonary disease. The benefits of inhaled therapy have long been recognised but the most important innovations have occurred over the past 60 years, beginning with the invention of the pressurised metered dose inhaler. However, despite over 230 different device and drug combinations currently being available, disease control is far from perfect. Here we look at how innovation in inhaler design may improve treatments for respiratory diseases and how new formulations may lead to treatments for diseases beyond the lungs...
September 2018: Breathe
Rakesh Sharma
Stem Cell Research and Tissue Engineering, in present time, have emerged as a legalized and regulated stem cell treatment option globally, but scientifically, their success is unestablished. Novel stem cell-based therapies have evolved as innovative and routine clinical solutions by commercial companies and hospitals across the world. Such rampant spread of stem cell clinics throughout UK, US, Europe and Asia reflect the public encouragement of benefits to incurable diseases. However, ever growing stem cell therapy developments need constant dogwatch and careful policy making by government regulatory bodies for prompt action in case of any untoward public concern...
August 30, 2018: Current Drug Targets
Michael A Bohl, Jacob F Baranoski, Daniel Sexton, Peter Nakaji, Laura A Snyder, U Kumar Kakarla, Randall W Porter
OBJECTIVE: The Barrow Innovation Center comprises an educational program in medical innovation that enables residents to identify problems in patient care and rapidly develop and implement solutions to these problems. Residents involved in this program noted an elevated risk of iatrogenic spinal cord injury during posterior cervical and thoracic procedures. The objective of this study was to describe this complication, and a novel solution was developed through a new innovation training program...
August 27, 2018: World Neurosurgery
David S Jones, Kavita Sivaramakrishnan
In 1962, surgeons at two hospitals in Bombay used heart-lung machines to perform open-heart surgery. The devices that made this work possible had been developed in Minneapolis in 1955 and commercialized by 1957. However, restrictions on currency exchange and foreign imports made it difficult for surgeons in India to acquire this new technology. The two surgeons, Kersi Dastur and PK Sen, pursued different strategies to acquire the ideas, equipment, and tacit knowledge needed to make open-heart surgery work. While Dastur tapped Parsi networks that linked him to local manufacturing expertise, Sen took advantage of opportunities offered by the Rockefeller Foundation to access international training and medical device companies...
August 2018: Social Studies of Science
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
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
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