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1 the management of anaphylaxis when using the medical device.
2 the shaved scalp and connected to a portable medical device.
3 ly interface with an off-the-shelf, approved medical device.
4 -month periods, one with and one without the medical device.
5 such as surgery or presence of an indwelling medical device.
6 formation of a biofilm on the surface of the medical device.
7 e primary endpoint was satisfaction with the medical device.
8 dity of biofilms at their interface with the medical device.
9 tive evidence generation is even sparser for medical devices.
10 rug-delivery systems, bone-graft fillers and medical devices.
11 d infection of surgical sites and indwelling medical devices.
12 nged length of stay, and the use of invasive medical devices.
13 s, from robotics to perhaps even implantable medical devices.
14 is often precluded by the poor visibility of medical devices.
15 uld power sometimes in the future integrated medical devices.
16 that limit sustainable operation of wearable medical devices.
17 hich uses nanostructured mineral coatings on medical devices.
18  of online communication, cars and implanted medical devices.
19  can compromise the performance of implanted medical devices.
20 eter blockage, or biofilm formation on other medical devices.
21 effectiveness as a power source for wearable medical devices.
22 mplication resulting from biofilm fouling of medical devices.
23 ome this key challenge in the development of medical devices.
24 n the U.S. have access to safe and effective medical devices.
25 assessment of safety risks of newly approved medical devices.
26  electronics, micro-devices, and implantable medical devices.
27 al polymer routinely used for cardiovascular medical devices.
28 tolerant infections in humans and fouling of medical devices.
29 tions associated with the use of implantable medical devices.
30 ell-designed, valid postmarketing studies of medical devices.
31 t tissue-lubricating dysfunction and to coat medical devices.
32 event thrombotic occlusion and biofouling of medical devices.
33 oft robotics, adhesive systems or biomedical medical devices.
34 e storage material to power certain types of medical devices.
35 sent regulatory hurdles for use in temporary medical devices.
36 s on a variety of host tissues and implanted medical devices.
37  biofilm-associated infections on indwelling medical devices.
38 a role in early stage infection of implanted medical devices.
39 key challenges to the optimal performance of medical devices.
40 le maintaining high shear adhesion to secure medical devices.
41  the development of novel bio-optoelectronic medical devices.
42 ing the analysis of potentially contaminated medical devices.
43 tly recovered from soft tissue and retrieved medical devices.
44 nts related to security and privacy risks of medical devices.
45  may be relevant to the development of other medical devices.
46 n central venous catheters and perhaps other medical devices.
47  consumer electronics but not in implantable medical devices.
48 ange membranes, protein crystallization, and medical devices.
49 ffectiveness of prescription medications and medical devices.
50  of novel biosensor platforms and a range of medical devices.
51 ociated with biofilms attached to indwelling medical devices.
52 can cause life-threatening interference with medical devices.
53 c surfaces in vitro as well as on indwelling medical devices.
54 s, are a cause of infections associated with medical devices.
55 ysaccharide capsule and can form biofilms on medical devices.
56 y for prevention of infections on indwelling medical devices.
57 ual testing of pharmacological therapies and medical devices.
58  preference information to aid evaluation of medical devices.
59 to accept risks associated with mitral valve medical devices.
60 fety and/or efficacy of new drugs and of new medical devices.
61 nd performance of implanted biomaterials and medical devices.
62 halate exposure through contact with plastic medical devices.
63 ide near-real-time safety assessments of new medical devices.
64  regenerating organs and engineering new-age medical devices.
65 ibility and reduce infection associated with medical devices.
66 particularly when associated with indwelling medical devices.
67 ccess to medicines (including biologics) and medical devices; 3.
68 fied from Class 2 medical devices to Class 3 medical devices, a policy change that will prompt additi
69 A), and ten by the Japan Pharmaceuticals and Medical Devices Agency (PMDA).
70  colonies that may adhere to the surfaces of medical devices and are major contributors to infections
71  These bacteria can also attach to implanted medical devices and develop surface-associated biofilm c
72  of potential applications in drug delivery, medical devices and diagnostics.
73 on that can lead to the failure of implanted medical devices and discomfort for the recipient.
74  sophisticated approach to fabricate bespoke medical devices and drug delivery systems.
75 e might also serve as a test bed for cardiac medical devices and eventually lead to therapeutic tissu
76 nd their use in consumer products, including medical devices and food storage, and therefore requires
77 ne using two nested categories that included medical devices and glossary terms attributable to the U
78 lms, which are a major concern for implanted medical devices and in many diseases.
79  for applications that range from ingestible medical devices and microrobotics to tunable optoelectro
80 ns also readily forms biofilms on indwelling medical devices and mucosal tissues, which serve as an i
81 The growing demand for compact point-of-care medical devices and portable instruments for on-site env
82 her topics, Emergency Use Authorizations for medical devices and privacy laws of the USA and Europe.
83 lood compatible materials for application in medical devices and prostheses.
84                       The miniaturization of medical devices and the progress in image processing hav
85 ding generation of biocompatible implantable medical devices and tissue scaffolds.
86 ntral European Union (EU) control agency for medical devices and to reevaluate safety procedures curr
87 ce the development of self-powered implanted medical devices and wearable/portable electronics.
88 tic biofuel cells (BFCs) may power implanted medical devices and will rely on the use of glucose and
89 ons such as wireless powering of implantable medical devices and wireless charging of stationary elec
90  significant interest to the pharmaceutical, medical device, and cosmetic industries.
91 ships between physicians and pharmaceutical, medical device, and other medically related industries h
92 rgical intervention, consider treatment with medical devices, and actively seek nonpharmacologic alte
93 ts, preventing inappropriate colonization in medical devices, and combatting bacterial infections.
94 vention of wound infections, colonization of medical devices, and nosocomial transmission of microorg
95 s in the control group received all standard medical, device, and disease management strategies avail
96 findings may be particularly translatable to medical device applications.
97 ich may offer a new strategy for a number of medical device applications.
98 ean Union (EU) are weighing reforms to their medical device approval and post-market surveillance sys
99 e and German Federal Institute for Drugs and Medical Devices approval.
100 taminated environmental surfaces, and shared medical devices are areas that require management by oph
101                    Skin-targeting microscale medical devices are becoming popular for therapeutic del
102                                              Medical devices are common in clinical practice and have
103                              Skin-interfaced medical devices are critically important for diagnosing
104        Candida biofilms formed on indwelling medical devices are increasingly associated with severe
105 tegies for ensuring the postmarket safety of medical devices are limited by small sample size and rel
106                         Emerging micro-scale medical devices are showing promise, whether in deliveri
107 , especially those associated with implanted medical devices, are difficult to eradicate.
108 blem because they commonly form on implanted medical devices, are drug resistant and are difficult to
109     Such transition is especially desired in medical devices as rigidity facilitates the implantation
110 l designated investigational drugs, and some medical devices, as well as documented patient harm and
111 y has broad applications in blood-contacting medical devices, as well as various other applications r
112                      The commonly identified medical devices associated with the risk of developing m
113  cell anemia, sepsis, transfusion reactions, medical-device associated hemolysis, or after a subarach
114                                              Medical device-associated infections involve the attachm
115                                    Implanted medical device-associated infections pose significant he
116 olonizer of human skin and a common cause of medical device-associated infections.
117 oist surfaces on Earth and cause chronic and medical device-associated infections.
118 bicans, whose biofilms are a major source of medical device-associated infections.
119         Candida species are a major cause of medical device-associated infections.
120 d health are driving innovations in wearable medical devices at a tremendous pace.
121    Traditional antibiotic therapy to control medical device-based infections typically fails to clear
122 ustry reduced early-stage research, favoring medical devices, bioengineered drugs, and late-stage cli
123 ategies to fabricate ECM-like interfaces for medical devices, but also offers the capability of spati
124     Biofilm infections of certain indwelling medical devices by common pathogens such as staphylococc
125 sents an attractive and emerging paradigm in medical devices by harnessing simultaneous advantages af
126 mising platform for generating a large-scale medical device capable of augmenting liver function in a
127 n and can be prospectively translated into a medical device capable of molecular imaging.
128 nement of ventricular assist devices (VADs), medical devices capable of maintaining circulatory outpu
129 sity, German Federal Institute for Drugs and Medical Devices, Carlos III Spanish Health Institute, Eu
130 ng of extracorporeal circuits and indwelling medical devices cause significant morbidity and mortalit
131    Microbial biofilm formation on indwelling medical devices causes persistent infections that cannot
132 yet often fail routinely as a consequence of medical-device-centered infections.
133                       Ensuring the safety of medical devices challenges current surveillance approach
134  most commonly for maintenance chemotherapy, medical device complications, or recurrent sepsis.
135                                     Flexible medical devices designed for monitoring human vital sign
136                            NISs are emerging medical devices designed to allow persons with paralysis
137                    Although AEDs are complex medical devices designed to function during life-threate
138 This has significant health implications for medical device development in the future that can be use
139                               More recently, medical device development through traditional clinical
140 policies aimed at encouraging transformative medical device development would have their greatest eff
141 en evaluated in clinical trials for drug and medical device development.
142 r dental applications and broader utility in medical device development.
143 ing many of the stakeholders associated with medical device development.
144 ndency on HCWs for care, the presence of any medical device, diabetes mellitus, and chronic skin brea
145 ts sponsored or supported by pharmaceutical, medical device, diagnostics, and biotechnology companies
146   We sought to evaluate satisfaction using a medical device (digital technology comprising an EAI sma
147  utility of the recently In Vitro Diagnostic Medical Devices Directive-approved Roche COBAS AmpliPrep
148 own about how commonly survivors acquire new medical devices during pediatric severe sepsis hospitali
149              Overall, 90% patients found the medical device easy to use.
150          Many devices, including implantable medical devices, enter the market through a regulatory p
151                                              Medical device epidemiology is a relatively new field co
152 siderations in pharmacoepidemiology apply to medical device epidemiology.
153                          Despite advances in medical device fabrication and antimicrobial treatment t
154 lications in the fields of drug delivery and medical device fabrication, material examples and the ad
155                                              Medical devices face nonspecific biofouling from protein
156 dustry, large biotechnology firms, and large medical device firms.
157 ins with adhesion to host cells or implanted medical devices followed by biofilm formation.
158 t may eventually lead to a low-cost personal medical device for chronic disease early detection, diag
159 nd Drug Administration approval in 1988 as a medical device for the treatment of CTCL patients, one o
160 put are vital to screening food products and medical devices for chemical or biochemical contaminants
161 e development of injectable hydrogels as new medical devices for controlled delivery and filling purp
162 the guise of tissue engineering scaffolds or medical devices for drug delivery.
163 ery vehicles in addition to tablets, such as medical devices for example.
164 ion approvals for new molecular entities and medical devices for indications within the neurosciences
165  greatly facilitate applications in portable medical devices for on-the-spot diagnosis and even the p
166 ar microneedle patches have become promising medical devices for the delivery of various antibacteria
167 re sufficient to wirelessly power a range of medical devices from outside of the body.
168 tmigration of the development and testing of medical devices from the United States.
169 nal luminal imaging probe (EndoFLIP; Crospon Medical Devices, Galway, Ireland).
170 em included an artificial intelligence-based medical device (GI-Genius, Medtronic) trained to process
171           The development of new implantable medical devices has been limited in the past by slow adv
172 anipulation for employment as a conductor in medical devices, has gathered substantial interest in th
173                                  Implantable medical devices have been used for real-time monitoring
174 , traditionally defined as materials used in medical devices, have been used since antiquity, but rec
175  It could play an important role in wearable medical devices if they can be fabricated on flexible su
176 ethanol 25%, and Ca-EDTA 3% (investigational medical device [IMD]) or heparin 5000 U/mL active contro
177 tes in human blood and urine for implantable medical devices (IMDs) was investigated.
178 f Gordonia araii infection associated with a medical device in an immunocompetent patient.
179  can form biofilms on polystyrene plates and medical devices in a process that requires capsular poly
180 ng biofilms frequently develop on indwelling medical devices in hospitalized patients, and Staphyloco
181 te of research with regard to both drugs and medical devices in order to highlight their limits and t
182 dation facilitated surface re-engineering of medical devices in situ after in vivo implantation throu
183  and Drug Administration also approved 1,679 medical devices in the neurosciences for use.
184 ccess to early-stage, potentially beneficial medical devices in the United States.
185 ents and as a means to improve the design of medical devices in which RBCs are susceptible to subleth
186 crucial step in the development of implanted medical devices, in vivo diagnostics, and microarrays is
187 films are notorious for forming on implanted medical devices, including catheters, pacemakers, dentur
188                                              Medical devices increasingly depend on computing functio
189 ents and faculty with the pharmaceutical and medical device industries.
190 nvolving professional medical societies, the medical device industry, and the FDA.
191 ystic fibrosis lung infection(4), as well as medical device infection and associated bacteraemia(5-7)
192 nsight into the observed correlation between medical device infection and thromboembolism; the increa
193         Although most experimental models of medical device infection draw upon isolated bacterial bi
194  we study, to our knowledge, a new model for medical device infection-that of an infected fibrin clot
195 r case to the 16 Gordonia species-associated medical device infections reported to date.
196 is is a major cause of healthcare-associated medical device infections.
197 athogen that is one of the leading causes of medical device infections.
198           The effects of electrostimulation, medical devices, injectable bulking agents, and local es
199  about the cardiac system and support future medical device innovation.
200 ed Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life
201                              Introducing new medical devices into routine practice raises concerns be
202                    Microbial colonization of medical devices is a widespread problem that tests the l
203              The ability to form biofilms on medical devices is an important aspect of pathogenesis i
204                    The funding landscape for medical devices is becoming increasingly difficult and c
205 reaction (FBR) to implanted biomaterials and medical devices is common and can compromise the functio
206        The process of assuring the safety of medical devices is constrained by reliance on voluntary
207 e engaged in research to develop implantable medical devices is to develop mechatronic implantable ar
208  need for new therapeutic advances and novel medical devices is urgent.
209 alf of which can be attributed to indwelling medical devices, is a strong risk factor for thromboembo
210  used anticoagulant in drug formulations and medical devices, is critical to ensuring public health.
211 o its ability to form biofilms on indwelling medical devices, it has emerged as a leading cause of no
212 e Xpert MRSA/SA BC test (in vitro diagnostic medical device [IVD]).
213 ical Trials for Development of New Drugs and Medical Devices, Japan Agency for Medical Research; and
214 rm communities (called biofilms) on inserted medical devices, leading to infections that affect many
215             A paradigm shift for implantable medical devices lies at the confluence between regenerat
216                                   Innovative medical devices make major contributions to patient welf
217  the general public, clinical community, and medical device manufacturers with a more accurate unders
218 r adoption by relevant regulatory bodies and medical device manufacturers.
219 l technology with the potential to transform medical device manufacturing, organ replacement, and the
220 ase professionals to understand that fomites/medical devices may be a source of HAIs.
221 n reinforcing polymers, adhesives, textiles, medical devices, metallic alloys, and even concrete.
222 es used to support FDA approval of high-risk medical device modifications, fewer than half were rando
223 vestigated in recent reports, which involved medical devices, nanoparticles, quantum dots and nanofib
224 at the pores created by the microneedle-type medical device, Nanopatch(R), are transient, with the sk
225                        Surface biofouling of medical devices occurs as a result of nonspecific adhesi
226 triboelectric nanogenerators for implantable medical devices offer advantages of excellent output per
227 an that comparative effectiveness studies of medical devices often necessitate additional and differe
228                                    High-risk medical devices often undergo modifications, which are a
229 ckings are the most widely used non-invasive medical device on the market and are believed to reduce
230 ce of recent hospital admission, an invasive medical device, or residence in a long-term care facilit
231 range of applications in household products, medical devices, or manufacturing.
232 on of contaminated products, use of invasive medical devices, or variances in practices and procedure
233 uring the study, all in patients without the medical device (P = .025).
234             The endotracheal tube (ETT) is a medical device placed in the patient's trachea to assist
235 sumer products (including soaps, toothpaste, medical devices, plastics, and fabrics) that are regulat
236                                              Medical devices play a vital role in diagnosing, treatin
237  include the inadequacy of trial research on medical devices, problems with industry-sponsored trials
238 rdioverter-defibrillators (ICDs) are complex medical devices proven to reduce mortality in specific h
239                                              Medical devices provide an ecological niche for microbes
240 ion of functional coatings on titanium-based medical devices provides osseoinductive bioactive molecu
241     Few studies have quantitatively assessed medical device regulation in either the US or EU.
242  review to find empirical studies evaluating medical device regulation in the US or EU.
243  strengths and weakness of the approaches to medical device regulation in these settings.
244 t to the European Medicines Agency, European medical device regulatory agencies, US Food and Drug Adm
245 s including "conventional pressure ulcers", "medical device related pressure injuries", "pressure inj
246 ic Staphylococcus aureus biofilm-associated, medical device-related infections.
247 that reported the prevalence or incidence of medical device-related pressure injuries and published i
248                                              Medical device-related pressure injuries are among key i
249 ng the 'metaprop' routine, with estimates of medical device-related pressure injuries from the includ
250 vices associated with the risk of developing medical device-related pressure injuries include respira
251 estimated pooled incidence and prevalence of medical device-related pressure injuries were 12% (95% C
252 o-date estimates of the extent and nature of medical device-related pressure injuries, and the findin
253 reasing the reporting and risk assessment of medical device-related pressure injuries.
254 n a number of activities aimed at mitigating medical device-related TASS outbreaks.
255 que has the potential to assess biosensor or medical device responses in complex biological matrices.
256 rly warnings in the postmarket evaluation of medical device safety but has not been demonstrated in n
257            Current approaches for postmarket medical device safety surveillance are limited in their
258 rly warnings in the postmarket evaluation of medical device safety.
259 he association between industry payments and medical device selection.
260  to form Candida biofilms on three different medical device substrates (denture strips, catheter disk
261 spective, we reflect on lessons learned from medical device successes and failures and consider how s
262 rug Administration (FDA) evaluates high-risk medical devices such as cardiac implantable electronic d
263 roperties could be used to coat a variety of medical devices such as catheters as well as industrial
264 al of entry included surgery and presence of medical devices such as catheters or adhesive tape.
265 tility of l-DOPA in the field of implantable medical devices, such as biosensors, as well as tissue e
266                       Candida spp. adhere to medical devices, such as catheters, forming drug-toleran
267                          Candida spp. infect medical devices, such as venous and urinary catheters, b
268                                   Postmarket medical device surveillance in the United States depends
269                 The incorporation of complex medical device technologies into clinical practice is go
270 nical clutch system was developed for use in medical devices that access tissue and tissue compartmen
271 ions are associated with the implantation of medical devices that act as points of entry for the path
272 an adverse event associated with implantable medical devices that contain allergenic materials like n
273 ss Pathway was designed as a new program for medical devices that demonstrated the potential to addre
274 the development of revolutionary implantable medical devices that extract the power they require from
275 defibrillators (ICDs) are generally reliable medical devices that have the potential to add quality y
276  microbiome, and increased use of indwelling medical devices that provide sites for biofilm formation
277 ation is a major complication of implantable medical devices that results in therapeutically challeng
278  of small silicon chips (used to mimic small medical devices) that were coated with the composite for
279 actice of medicine and in the development of medical devices, the study of the heart in three dimensi
280 Drug Administration (FDA) approves high-risk medical devices, those that support or sustain human lif
281 pair were recently reclassified from Class 2 medical devices to Class 3 medical devices, a policy cha
282 combination of MDD technologies with classic medical devices to create multifunctional MDD devices th
283  to their use in many products, ranging from medical devices to industrial cutting tools.
284 nce in various areas ranging from indwelling medical devices to industrial setups.
285 s regulatory landscape to successfully bring medical devices to patients.
286 his is utilized in antibacterial coatings on medical devices to reduce nosocomial infection rates.
287 on in technologies ranging from experimental medical devices to telecommunications and airport securi
288 s at multiple scales, ranging from miniature medical devices to wearable robotic exoskeletons to larg
289               (CE Mark Study for the Harpoon Medical Device [TRACER]; NCT02768870).
290 e some of the simplest and cheapest types of medical devices used in the rapid detection of biomarker
291 lococcus aureus forms biofilms on indwelling medical devices using a variety of cell-surface proteins
292  visual analogue scale (VAS) after using the medical device was higher than before its use (89.1 [95%
293 abetes mellitus, and presence of implantable medical device was studied to gain insights into this qu
294 s inhibited bacterial spread from indwelling medical devices, we have provided proof of principle tha
295      Different injectable bulking agents and medical devices were associated with similar continence
296 ction is a major complication of implantable medical devices, which provide a scaffold for biofilm fo
297     The introduction of new and more complex medical devices will likely increase the risk that such
298 rticular, replacing batteries in implantable medical devices with electrical harvesting is a great ch
299 fouling, but also promote the integration of medical devices with the biological environment.
300 f prospective, active safety surveillance of medical devices within a national cardiovascular registr

 
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