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Innovative medical devices

Dariusz Dudek, Waldemar Banasiak, Wojciech Braksator, Jacek Dubiel, Tomasz Grodzicki, Piotr Hoffman, Mariusz Kuśmierczyk, Grzegorz Opolski, Piotr Ponikowski, Jacek Różański, Jerzy Sadowski, Wojciech Wojakowski, Marcin Grabowski, Katarzyna Bondaryk, Jacek Walczak, Izabela Pieniążek, Maciej Grys, Anna Lesiak-Bednarek, Piotr Przygodzki
There is a great need for innovative technologies that will improve the health and quality of life (QoL) of Polish patients with cardiac problems. It is important that the safety and effectiveness of the technology are confirmed by scientific evidence on which guidelines and clinical recommendations are based. Scientific evidence for medical devices is also increasingly important for decision-making in finance approval from public funds. New technologies in cardiology and cardiac surgery contribute to improved patient QoL, increased treatment effectiveness and facilitated diagnosis...
February 14, 2019: Cardiology Journal
Jiaqian Li, Yuxin Song, Huanxi Zheng, Shile Feng, Wanghai Xu, Zuankai Wang
Just as the innovation of electronic diodes that allow the current to flow in one direction provides a foundation for the development of digital technologies, the engineering of surfaces or devices that allow the directional and spontaneous transport of fluids, termed liquid diodes, is highly desired in a wide spectrum of applications ranging from medical microfluidics, advanced printing, heat management and water collection to oil-water separation. Recent advances in manufacturing, visualization techniques, and biomimetics have led to exciting progress in the design of various liquid diodes...
February 13, 2019: Soft Matter
Armando Tellez, Marco Ferrone, Juan F Granada
Significant improvements in quality of life and mortality have occurred over the last century due to the giant advancements in medical innovation. Medical innovation continues to move forward, and it is expanding to areas never explored before. In particular, the advancement in big data analytics is now enabling the rapid progress in the understanding of gene influence in human diseases. The progress in medical innovation achieved until today is significant; however, the potential that future technologies have to modify patterns of disease thought to be incurable is mind-boggling...
February 11, 2019: Toxicologic Pathology
David S Mulder, Jonathan Spicer
Registry based medical research is an important tool in assessing health care interventions in the general population. They are observational studies used to establish effectiveness while randomized clinical trials assess efficacy in an experimental manner targeting a carefully selected population of patients. A medical registry may be office or hospital based, state/provincial, national or more recently global in nature. The role in post-marketing pharmaco-surveillance is effective in detecting early adverse events and long-term benefits...
February 8, 2019: Annals of Thoracic Surgery
Jeff R Anderson, Thomas D Y Chung, Leon Clark, Jennifer A Weis, Andrew J Danielsen, Sundeep Khosla, Gregory J Gores, Andrew D Badley
The Office of Translation to Practice (OTP) is housed in the Center for Clinical and Translational Sciences at Mayo Clinic. Established in 2015, the office was tasked with developing and managing novel tools, mechanisms, and processes to facilitate and accelerate the translation of products, such as drugs, biological agents, and medical devices, into practice. Since its inception, the OTP is credited with creating valuable services through several strategic alliances and active scientific and project management involvement...
February 6, 2019: Mayo Clinic Proceedings
Nicole Kirchhof
Medical device pathologists are involved in the preclinical evaluation of medical devices that will be temporarily inserted or permanently and often irreversibly implanted in the human body. The medical device industry is technology based, allowing for rapid device iterations; innovations occur at an accelerated rate compared to the innovations in the pharmaceutical industry. The device pathologist provides the pathology results and is, by training and experience, in an ideal position to help the medical engineer and innovator tackle biomedical problems and to comment on the possible and actual outcomes of preclinical studies...
February 5, 2019: Toxicologic Pathology
Kahlia McCausland, Bruce Maycock, Tama Leaver, Jonine Jancey
BACKGROUND: There has been a rapid rise in the popularity of electronic cigarettes (e-cigarettes) over the last decade, with growth predicted to continue. The uptake of these devices has escalated despite inconclusive evidence of their efficacy as a smoking cessation device and unknown long-term health consequences. As smoking rates continue to drop or plateau in many well-developed countries, transnational tobacco companies have transitioned into the vaping industry and are now using social media to promote their products...
February 5, 2019: Journal of Medical Internet Research
Rita Rebelo, Ana I Barbosa, David Caballero, Il Keun Kwon, Joaquim M Oliveira, Subhas C Kundu, Rui L Reis, Vitor M Correlo
Cardiovascular diseases, cancer, and diabetes are high mortality diseases, which account for almost two thirds of all deaths worldwide. Their early detection and continuous evaluation are fundamental for an improved patient prognosis and reduced socioeconomic impact. Current biosensor technologies are typically based on the analysis of whole blood samples from patients for the detection of disease-specific biomarkers. However, these technologies display serious shortcomings, such as reduced sensitivity and dynamic range, limited in vivo applicability, and lack of continuous monitoring...
January 11, 2019: Biosensors & Bioelectronics
Anne Runyan, Jordan Banks, Daniele Severi Bruni
BACKGROUND: The cost of treating cancer patients is high and rising in the United States. Payers are exposed to cost through doctor visits, laboratory tests, imaging tests, radiation treatment, drugs, hospital stays, surgery, home care, transportation and travel, and caregiving. This study focuses on the cost of medication from the viewpoint of U.S. payers. Although new tools for managing these costs have been gaining attention, prices continue to rise, and challenges to managing costs remain high...
February 2019: Journal of Managed Care & Specialty Pharmacy
Javad Yasbolaghi Sharahi, Taher Azimi, Aref Shariati, Hossein Safari, Melika Khanzadeh Tehrani, Ali Hashemi
Biofilms are communities of microorganisms that are formed on and attached to living or nonliving surfaces and are surrounded by an extracellular polymeric material. Biofilm formation enjoys several advantages over the pathogens in the colonization process of medical devices and patients' organs. Unlike planktonic cells, biofilms have high intrinsic resistance to antibiotics and sanitizers, and overcoming them is a significant problematic challenge in the medical and food industries. There are no approved treatments to specifically target biofilms...
January 29, 2019: Journal of Cellular Physiology
Shaunak K Bakshi, Eleftherios I Paschalis, John Graney, James Chodosh
PURPOSE: Severe corneal disease contributes significantly to the global burden of blindness. Corneal allograft surgery remains the most commonly used treatment, but does not succeed long term in every patient, and the odds of success fall with each repeated graft. The Boston keratoprosthesis type I has emerged as an alternative to repeat corneal allograft. However, cost limits its use in resource-poor settings, where most corneal blind individuals reside. METHODS: All aspects of the Boston keratoprosthesis design process were examined to determine areas of potential modification and simplification, with dual goals to reduce cost and improve the cosmetic appearance of the device in situ...
January 23, 2019: Cornea
Nuria Oliver, Oscar Mayora, Michael Marschollek
INTRODUCTION: This accompanying editorial provides a brief introduction to this focus theme, focused on "Machine Learning and Data Analytics in Pervasive Health". OBJECTIVE: The innovative use of machine learning technologies combining small and big data analytics will support a better provisioning of healthcare to citizens. This focus theme aims to present contributions at the crossroads of pervasive health technologies and data analytics as key enablers for achieving personalised medicine for diagnosis and treatment purposes...
September 2018: Methods of Information in Medicine
Yuki Ushimaru, Tsuyoshi Takahashi, Yoshihito Souma, Yoshitomo Yanagimoto, Hirotsugu Nagase, Koji Tanaka, Yasuhiro Miyazaki, Tomoki Makino, Yukinori Kurokawa, Makoto Yamasaki, Masaki Mori, Yuichiro Doki, Kiyokazu Nakajima
BACKGROUND: With the improvement of sensor technology, the trend of Internet of Things (IoT) is affecting the medical devices. The aim of this study is to verify whether it is possible to "visualize instrument usage in specific procedures" by automatically accumulating the digital data related to the behavior of surgical instruments/forceps in laparoscopic surgery. METHODS: Five board-certified surgeons (PGY 9-24 years) performed laparoscopic cholecystectomy on 35-kg porcine (n = 5)...
January 22, 2019: Surgical Endoscopy
Aldo Badano, Christian G Graff, Andreu Badal, Diksha Sharma, Rongping Zeng, Frank W Samuelson, Stephen J Glick, Kyle J Myers
Importance: Expensive and lengthy clinical trials can delay regulatory evaluation of innovative technologies, affecting patient access to high-quality medical products. Simulation is increasingly being used in product development but rarely in regulatory applications. Objectives: To conduct a computer-simulated imaging trial evaluating digital breast tomosynthesis (DBT) as a replacement for digital mammography (DM) and to compare the results with a comparative clinical trial...
November 2, 2018: JAMA network open
Akhilesh Kumar Singh, Janmejai Kumar Srivastava, Anuj Kumar Chandel, Laxuman Sharma, Nirupama Mallick, Satarudra Prakash Singh
Biopolymeric polyhydroxyalkanoates (PHAs) are fabricated and accumulated by microbes under unbalanced growth conditions, primarily by diverse genera of bacteria. Over the last two decades, microbially engineered PHAs gained substantial interest worldwide owing to their promising wide-range uses in biomedical field as biopolymeric biomaterials. Because of non-hazardous disintegration products, preferred surface alterations, inherent biocompatibility, modifiable mechanical properties, cultivation support for cells, adhesion devoid of carcinogenic impacts, and controllable biodegradability, the PHAs like poly-3-hydroxybutyrate, 3-hydroxybutyrate and 3-hydroxyvalerate co-polymers, 3-hydroxybutyrate and 4-hydroxybutyrate co-polymers, etc...
January 15, 2019: Applied Microbiology and Biotechnology
Danielle M Vossebeld, Erik C N Puik, Joris E N Jaspers, Marieke J Schuurmans
BACKGROUND: With the growing shortage of nurses, labor-saving technology has become more important. In health care practice, however, the fit with innovations is not easy. The aim of this study is to analyze the development of a mobile input device for electronic medical records (MEMR), a potentially labor-saving application supported by nurses, that failed to meet the needs of nurses after development. METHOD: In a case study, we used an axiomatic design framework as an evaluation tool to visualize the mismatches between customer needs and the design parameters of the MEMR, and trace these mismatches back to (preliminary) decisions in the development process...
January 14, 2019: BMC Medical Informatics and Decision Making
Paul Neuville, Nicolas Morel-Journel, Delphine Cabelguenne, Alain Ruffion, Philippe Paparel, Jean-Etienne Terrier
INTRODUCTION: The ZSI 475FtM is a new prosthesis that has recently been specifically designed for phalloplasty. It has several functions that have been conceived to answer the challenges of implantation after phalloplasty: a large base for pubic bone fixation, realistically shaped hard glans, and a pump shaped like a testicle. AIM: To assess the safety, feasibility, and patient satisfaction of the ZSI 475 FtM. METHODS: Surgical outcomes were analyzed after implantation of the prosthesis between June 2016 and September 2017 (single institution, single surgeon)...
January 9, 2019: Journal of Sexual Medicine
Tetsuro Uchida, Mitsuaki Sadahiro
Thoracic endovascular aortic repair (TEVAR) for thoracic aortic disease constitutes a paradigm shift in the treatment strategy of aortic dissection, as well as thoracic aortic aneurysms. Conventionally, most patients with Stanford type B acute aortic dissection are treated using conservative medical treatment during the acute phase. However, in patients with complicated type B aortic dissection who present with life-threatening complications, TEVAR has been introduced as a novel and less-invasive alternative and has shown better early results than those observed with conventional therapy...
December 25, 2018: Annals of Vascular Diseases
Farooq Ali Khan, Kaushik Narasimhan, Csv Swathi, Sayyad Mustak, Gulam Mustafa, Mohammad Zaki Ahmad, Sohail Akhter
BACKGROUND: 3D printing/Additive Manufacturing seems a pragmatic approach to realize the quest for a truly customized and personalized drug delivery. 3DP technology, with innovations in pharmaceutical development and an interdisciplinary approach to finding newer Drug Delivery Systems can usher a new era of treatments to various diseases. The true potential of this is yet to be realized, and the US-FDA is focusing on the regulatory science of 3D printed medical devices to help patients access this technology safely and effectively...
January 10, 2019: Current Pharmaceutical Design
David Flannery, Robert Jarrin
The evolution of digital health is entwined with federal regulation and policy. Whether considering what is or is not a medical device, the reimbursement for digital medical technologies, or physician services under Medicare or Medicaid related to remote patient monitoring or telehealth, the rules and policies governing digital health have not been easy to distinguish. In the face of rapid innovation, it has been difficult to fit these products and services into existing regulations of the Food and Drug Administration and the Centers for Medicare and Medicaid Services, particularly when these frameworks never contemplated what communications technologies can do today...
December 2018: Health Affairs
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