Expert Review of Medical Devices

Article	Citations
Appropriate use criteria of left atrial appendage closure devices: latest evidences	186
From plugging air leaks to reducing lung volume: a review of the many uses of endobronchial valves	91
Comparison of 6-lead smartphone ECG and 12-lead ECG in athletes and a genetic heart disease population	70
Pulsed field ablation for atrial fibrillation	48
Delivering epilepsy care in low-resource settings: the role of technology	35
Hydrophilic biomaterial intravenous hydrogel catheter for complication reduction in PICC and midline catheters	33
The current status of breakthrough devices designation in the United States and innovative medical devices designation in Korea for digital health software	31
RETRACTED ARTICLE: Anatomy of a Woebot® (WB001): agent guided CBT for women with postpartum depression	29
Statement of Retraction	28
The role of robotic technology in minimally invasive surgery for mitral valve disease	27
Managing complications after transcatheter aortic valve implantation	27
Efficacy and safety of mechanical thrombectomy in acute stroke patients with pre-morbid disability	26
Devices to enhance organ perfusion during cardiopulmonary resuscitation	26
Long axial field-of-view PET/CT devices: are we ready for the technological revolution?	26
Correlative effect between sac regression and clinical outcomes following endovascular repair in abdominal aortic aneurysm: fact or myth?	25
The Incraft stent graft for the treatment of abdominal aortic aneurysms: an iliac-friendly device with an effective conventional proximal sealing mechanism	25
Partial vs full glottic view with CMACTM D blade intubation of airway with simulated cervical spine injury: a randomized controlled trial	24
Implantable cardioverter defibrillators and devices for cardiac resynchronization therapy: what perspective for patients’ apps combined with remote monitoring?	23
A review of modeling and control of remote-controlled capsule endoscopes	23
Cryoballoon ablation beyond pulmonary vein isolation in the setting of persistent atrial fibrillation	23
Updates in immunocompatibility of biomaterials: applications for regenerative medicine	23
Mixed reality in interventional radiology: a focus on first clinical use of XR90 augmented reality-based visualization and navigation platform	20
Considering alternatives to transcatheter heart valves for managing patients with severe aortic valve stenosis	19
Phosphorus-32 microparticles for locally advanced pancreatic cancer: how and when?	18
Haemodynamic support with percutaneous devices in patients with cardiogenic shock: the current evidence of mechanical circulatory support	18

18 F-FDG PET/CT technology for the assessment of brown adipose tissue: an updated review	17
Device evaluation: eCoin #x2013; implantable tibial nerve stimulator for overactive bladder	17
[18F]FDG PET-TC radiomics and machine learning in the evaluation of prostate incidental uptake	17
Forced inspiratory suction and swallow tool (FISST): an automation of Valsalva maneuver variants for therapeutic interventions	17
Total-body PET/CT: how will it change theranostics in oncology?	17
Novel insights into thoracic endografts technology for prevention of distal stent-graft induced new entry (dSINE) following endovascular repair of type B aortic dissections: from bench to bedside	16
Agreement of anterior segment measurements between four diagnostic imaging devices in myopic patients	16
Therapeutic biliary stents: applications and opportunities	16
Effect of congestive heart failure on safety and efficacy of left atrial appendage closure in patients with non-valvular atrial fibrillation	16
Axial length measurement failure rates using optical biometry based on swept-source OCT in cataractous eyes	15
Repeatability and reproducibility of anterior lens zonule length measurement using ArcScan insight 100 very high-frequency ultrasound	15
COVID-19 lessons learned: medical devices at the core of global healthcare. A foreword on new challenges for expert review of medical devices!	15
American and European legislation on border medical devices	14
Device profile of the sapphire XTM anterior cervical plate system: overview of its safety and efficacy	14
The CardioMEMS Heart Failure System for chronic heart failure – a European perspective	14
Hearables, in-ear sensing devices for bio-signal acquisition: a narrative review	13
Usefulness of insertable cardiac monitors for risk stratification: current indications and clinical evidence	13
Transcatheter valve-in-valve implantation for degenerated bioprosthetic aortic and mitral valves – an update on indications, techniques, and clinical results	13
Treatment of cardiac resynchronization therapy non-responders: current approaches and new frontiers	13
Resilient design: decentralized trials recovered faster from the impact of COVID-19 than traditional site-based designs	13
Evaluation of validity and reliability of novel rapid measurement for infundibulopelvic angle: a comparison with PACS system	12
Digital healthcare technologies: Modern tools to transform prosthetic care	12
Truss implant technology™ for interbody fusion in spinal degenerative disorders: profile of advanced structural design, mechanobiologic and performance characteristics	12
Deep brain stimulation programming strategies: segmented leads, independent current sources, and future technology	12
A retrospective study of reported adverse events associated with cardiac stents in Indian population	11
Ablate and pace strategy for atrial fibrillation: pacing modalities, ablation approaches and impact on patient outcomes	11
Data-driven monitoring in patients on left ventricular assist device support	11
S-ICDs: advantages and opportunities for improvement	11
Printing hearts: three-dimensional printing as a transformative technology in transcatheter mitral valve interventions	10
Devices for transcatheter mitral valve repair: current technology and a glimpse into the future	10
Efficacy of LMA gastro airway versus endotracheal tube for therapeutic endoscopic retrograde cholangiopancreatography under general anesthesia: a randomized trial	9
Bone biopsy devices - a patent review	9
Penile compression devices for the treatment of urinary incontinence: current status and future prospects	9
Comparative analysis of measurements of the anterior segment and the axial length parameters of the eyeball obtained with optical and ultrasound technique	9
A review on the treatment of intimal hyperplasia with perivascular medical devices: role of mechanical factors and drug release kinetics	9
Previous, current, and future stereotactic EEG techniques for localising epileptic foci	9
Device profile of Nerivio for the acute and preventive treatment of episodic or chronic migraine in patients 12 years and older	9
MRI-guided endovascular intervention: current methods and future potential	8
Single-pulse transcranial magnetic stimulation for assessment of motor development in infants with early brain injury	8
Emergency provider preference for powered intraosseous devices and satisfaction with features improving safety, reliability, and ease-of-use	8
Insertional effect following deep brain stimulation electrode implants	8
Atrial flow regulators for the treatment of pulmonary arterial hypertension: what does the future hold?	8
Validation of diagnostic accuracy of a handheld, smartphone-based rhythm recording device	8
Catamaran SI Joint Fusion System (R) MAINSAIL TM Study: a prospective, single-arm, multi-center, post-market study of six-month cl	8
Delivery systems for transcatheter therapies of congenital heart disease	8
Ankle sprain bracing solutions and future design consideration for civilian and military use	8
Cataract surgery: historical devices, modern innovations, and future perspectives	7
An overview of utilizing artificial intelligence in localized prostate cancer imaging	7
Advances in deep brain stimulation for the treatment of post-traumatic stress disorder	7
Research progress of portable extracorporeal membrane oxygenation	7

Low profile endografts for the endovascular treatment of abdominal aortic aneurysms	7
Vascular changes in optical coherence tomography angiography unveiling the depths of dry age-related macular degeneration: a review	7
Role of telemedicine in obstetrics and gynecology: an experience at tertiary care center	7
EVO/EVO+ Visian Implantable Collamer Lenses for the correction of myopia and myopia with astigmatism	7
Advancing clinical understanding of surface electromyography biofeedback: bridging research, teaching, and commercial applications	7
Right heart failure after durable left ventricular assist device implantation	7
Design of lower limb prosthetic sockets: a review	7
The role of feedback in the robotic-assisted upper limb rehabilitation in people with multiple sclerosis: a systematic review	7
Transcutaneous auricular vagus nerve stimulation effects on inflammatory markers and clinical evolution of patients with COVID-19: a pilot randomized clinical trial	7
Effect of posterior decompression and bone grafting combined with minimally invasive percutaneous pedicle screw fixation on pain and functional recovery in patients with thoracolumbar spinal fractures	6
A review of arrhythmia detection based on electrocardiogram with artificial intelligence	6
Advances in additive manufacturing processes and their use for the fabrication of lower limb prosthetic devices	6
Ambient assisted living systems for falls monitoring at home	6
Transcranial direct current stimulation combined with peripheral stimulation in chronic pain: a systematic review and meta-analysis	6
Comparative evaluation of SanAgile TM SA01 ultrasonic scalpel and Johnson & Johnson GEN11, and HAR36 for efficacy and safety	6
An accelerated access pathway for innovative high-risk medical devices under the new European Union Medical Devices and health technology assessment regulations? Analysis and recommendations	6
Noninvasive vagus nerve stimulation in Parkinson’s disease: current status and future prospects	6
Active esophageal cooling during radiofrequency ablation of the left atrium: data review and update	6
Chronic electroencephalography in epilepsy with a responsive neurostimulation device: current status and future prospects	6
Axonics® system for treatment of overactive bladder syndrome and urinary urgency incontinence	6
Compatibility and durability of the gel stent material	6
Modular cardiac rhythm management system and results of MODULAR ATP trial: an era of personalized device medicine	6
Percutaneous cryoneurolysis for acute pain management: current status and future prospects	6
Vigilance and medical devices: from theory to the field, the example of electroporation in atrial fibrillation	6
The use of predetermined change control plans to enable the release of new versions of software as a medical device	6
Early revision events among patients with a three dimensional (3D) printed cellular titanium or PEEK (polyetheretherketone) spinal cage for single-level lumbar spinal fusion	6
Recent developments in imaging and surgical vision technologies currently available for improving vitreoretinal surgery: a narrative review	6
Why did the number of US FDA medical device guidelines begin to rise in the mid-2010s? A perspective	6
Anterior segment swept-source optical coherence tomography and ultrasound biomicroscopy in iris and ciliary body lesions	5
Determinants of return to activity and work after carpal tunnel release: a systematic review and meta-analysis	5
Safe and effective use of a passive safety needle by healthcare professionals in a simulated environment, including perceptions and preferences	5
Device profile of the FLEX Vessel Prep System for the treatment of peripheral arterial disease: overview of its safety and efficacy	5
The modern pharmacological approach to diabetes: innovative methods of monitoring and insulin treatment	5
Evaluation of the safety and effectiveness of a sealant hemostatic patch for preventing cerebrospinal fluid leaks in cranial surgery	5
When is a wearable defibrillator indicated?	5
Device profile of the Zephyr endobronchial valve in heterogenous emphysema: overview of its safety and efficacy	5
Device profile of the VEST for external support of SVG Coronary artery bypass grafting: historical development, current status, and future directions	5
Expanding indications for drug-coated balloons in coronary artery disease	5
Comparative evaluation of blind supraglottic airway device insertion versus videolaryngoscope-guided technique in adults undergoing laparoscopic cholecystectomy	5
Hospital medical device quality and safety monitoring using real-world data from Friuli Venezia Giulia regional health coordination agency	5
Catheter ablation of atrial fibrillation: anticipating and avoiding complications	5
Safety and effectiveness of left atrial appendage closure in patients with non-valvular atrial fibrillation and prior major bleeding	5
Mortality in mechanically ventilated patients with COVID-19: a systematic review	5
Review of ankle rehabilitation devices for treatment of equinus contracture	5
The ‘Japanese paradox’ of total hip arthroplasty: where are we going?	4
Sex differences in 123I-mIBG scintigraphy imaging techniques in patients with heart failure	4
Endocardial versus epicardial pacing in pacemaker-dependent patients after device extraction: a meta-analysis	4
Caloric and galvanic vestibular stimulation for the treatment of Parkinson’s disease: rationale and prospects	4
A post-market, randomized, controlled, prospective study evaluating intrathecal pain medication versus conventional medical management in the non-cancer, refractory, chronic pain population (PROSPER)	4
Selection criteria in the era of perfect competition for drug-eluting stents - a survey of interventional cardiologists in Japan: the selection-DES study	4
Test-retest reliability of pain extent and pain location using a novel pain drawing analysis software application, on patients with shoulder pain	4
Anatomy of a Woebot® (WB001): agent guided CBT for women with postpartum depression	4
Development and verification of a novel bone collector with automatic size separating function for orthopedics surgery	4
Digital colposcopy image analysis techniques requirements and their role in clinical diagnosis: a systematic review	4
The current state, challenges, and future directions of deep brain stimulation for obsessive compulsive disorder	4
Frozen elephant use in type a dissection: fundamentals, innovations, and pitfalls	4
Device profile of the FlareHawk interbody fusion system, an endplate-conforming multi-planar expandable lumbar interbody fusion cage	4
The evolution of PET imaging in renal, bladder, upper urinary tract urothelial, testicular and penile carcinoma – Today’s impact, tomorrow’s potential	4
Bridging the gap in the symptomatic heart failure patient journey: insights from the Italian scenario	4
Endovascular reconstruction of the aortic arch with new-generation dual-branch and triple-branch endograft: design, applicability, indications, outcomes, and future directions	4
Is conduction system pacing a panacea for pacemaker therapy?	4
Recent advances in the direct anterior approach to total hip arthroplasty: a surgeon’s perspective	4
Artificial pancreas systems: experiences from concept to commercialisation	4
An update of interbody cages for spine fusion surgeries: from shape design to materials	4
FlowTriever Retrieval System for the treatment of pulmonary embolism: overview of its safety and efficacy	4
Clinical benefit of transcutaneous afferent patterned stimulation (TAPS) in essential tremor patients with high unmet need: a secondary analysis of TAPS studies	4
Evaluations of medical device usability during clinical investigations: a scoping review of clinical study protocols	4
Comparison of the HugeMed video laryngoscope with the Macintosh direct laryngoscope for nasotracheal tracheal intubation in children undergoing dental treatment: a randomized controlled clinical study	4
The frozen elephant trunk: an overview of hybrid prostheses	3
A profile on the WISE cortical strip for intraoperative neurophysiological monitoring	3
Agreement of predicted intraocular lens power using swept-source optical coherence tomography and partial coherence interferometry	3
Tests for the identification of reflex syncope mechanism	3
What challenges hinder the adoption of antimicrobial surface in the dental implant market?	3
Deep TMS H7 Coil: Features, Applications & Future	3
Economic evaluation of automated external defibrillator deployment in public settings for out-of-hospital cardiac arrest: a systematic review	3
Correction	3
A novel noncontact high-resolution charge density mapping system to guide ablation of complex atrial arrhythmias: overview of device technology and application	3
Effects of elevated body mass index on the success of total knee and total hip arthroplasty: a comprehensive overview	3
A profile on the CardioMEMS HF system in the management of patients with early stages of heart failure: an update	3
Addendum	3

Mechanical complications after total knee arthroplasty	3
Smart clothing for human movement analysis: future application in sport and clinical practice	3
A review: artificial intelligence in image-guided spinal surgery	3
Advances in intravascular lithotripsy: mechanisms, devices, and clinical applications	3
Peritoneal dialysis catheter design and function and implications for the clinical setting	3
Breaking the ice through an effective translationality in neurorehabilitation: are we heading to the right direction?	3
Can single-use bronchoscopes help prevent nosocomial COVID-19 infections?	3
Devices for osteoarthritis symptoms treatment: a patent review	3
Wearable devices for gait and posture monitoring via telemedicine in people with movement disorders and multiple sclerosis: a systematic review	3
Ultra high-frequency ultrasound in lymphatic surgery: the next frontier	3
Thoracic endovascular aortic repair completion following frozen elephant trunk: how it’s done and device selection	3
Estimate and reporting of longevity for cardiac implantable electronic devices: a proposal for standardized criteria	3
Digital therapeutics as a new weapon against diseases: focus on the current European legislation and possible therapeutic strategies	3
Singular secular Kuznets-like period realized amid industrial transformation in US FDA medical devices: a perspective on growth from 1976 to 2020	3
Biomaterial engineering surface to control polymicrobial dental implant-related infections: focusing on disease modulating factors and coatings development	3
Hemolysis during short-term mechanical circulatory support: from pathophysiology to diagnosis and treatment	3
Clinician satisfaction and preference for central venous catheter systems promoting patient safety, ease-of-use and reduced clinician error	3
Continuous glucose monitoring in persons with type 2 diabetes not using insulin	3
Therapeutic prostate cancer interventions: a systematic review on pubic arch interference and needle positioning errors	3
Mechanical ventilation in patients with acute respiratory distress syndrome: current status and future perspectives	3
Artificial intelligence in medical device software and high-risk medical devices – a review of definitions, expert recommendations and regulatory initiatives	3
A new horizon for aortic arch disease: the promise of total endovascular repair with triple-branched endografts	3
Limited value of current shoulder arthroplasty registries in evidence-based shoulder surgery: a review of 7 national registries	3
Treatment of brief episodes of highly symptomatic supraventricular and ventricular arrhythmias: a methodological review	3
Differentiation among bio- and augmented- feedback in technologically assisted rehabilitation	3
VisionGuard: enhancing diabetic retinopathy detection with hybrid deep learning	3
Device profile of EndoAnchors for aortic stent graft implantation: overview of their safety and efficacy	3
How robotic platforms are revolutionizing colorectal surgery techniques: a comparative review	3
Comparison of clinical effectiveness of fenestrated and conventional pedicle screws in patients undergoing spinal surgery: a systematic review and meta-analysis	3
Procedural embolic protection strategies for carotid artery stenting: current status and future prospects	2
Electrical neuromodulation for the treatment of chronic pain: derivation of the intrinsic barriers, outcomes and considerations of the sustainability of implantable spinal cord stimulation therapies	2
Video laryngeal masks in airway management	2
Telemedicine for hypertension management: a paradigm shift from telemonitoring to digital therapeutics	2
HeartlogicTM: ready for prime time?	2
An update on locoregional percutaneous treatment technologies in colorectal cancer liver metastatic disease	2
Navigating hypotony challenges with XEN gel implantation	2
Technology assistance in primary total knee replacement: hype or hope?	2
Device profile of the eversense continuous glucose monitoring system for glycemic control in type-1 diabetes: overview of its safety and efficacy	2
Comparative study of biomodels manufactured using 3D printing techniques for surgical planning and medical training	2
Study on the impact of sensitization on materiovigilance programme among pharmacy and dental postgraduate students	2
Use of the PRECICE nail for distraction osteogenesis after tumor resection	2
Design trends in actuated lower-limb prosthetic systems: a narrative review	2
Analysis of study designs and primary outcome measures in clinical trials of investigational suture materials	2
Promoting the widespread adoption of videolaryngoscopy: addressing resistance to change	2
Single-lead VDD pacing: a literature review on short-term and long-term performance	2
Antithrombotic therapy after transcatheter aortic valve implantation	2
Regulatory requirements and optimization of multiple criteria decision analysis to quantify the benefit-risk assessment of medical devices	2
Complications after peripherally inserted central catheter versus central venous catheter implantation in intensive care unit: propensity score analysis using a nationwide database	2
Reliability and validity of smartphone applications to measure the spinal range of motion: A systematic review	2
Toward applying a device to reduce motion artifact during imaging: a randomized controlled trial	2
Recent advances in devices and technologies that might prove revolutionary for colonoscopy procedures	2
Effects of a single session of noninvasive auricular vagus nerve stimulation on sports performance in elite athletes: an open-label randomized controlled trial	2
Preliminary study of 3D printing technology for extracorporeal positioning guide assisted ultrasound-guided microwave ablation of the liver	2
Optimizer Smart System for the treatment of chronic heart failure: Overview of its safety and efficacy	2
MetaHealth: unlocking metaverse technologies in digital healthcare	2
Transforming medical education: the impact of innovations in technology and medical devices	2
A randomized crossover comparison of the bébé VieScope and direct laryngoscope for pediatric airway management by nurses in medical simulation settings	2
Meta-analysis of clinical outcomes in cardiac resynchronisation therapy: his bundle pacing vs biventricular pacing	2
Peregrine system infusion catheter for neurolytic renal denervation in hypertension: an overview of its safety and efficacy	2
Value of colposcopy with dynamic spectral imaging in the detection and evolution of high-grade cervical lesions	2
Implantable medical devices for tendon and ligament repair: a review of patents and commercial products	2
The crucial role of fecal management systems in intensive care	2
Reevaluating medication adherence in the era of digital health	2
Hydrus microstent for the treatment of primary open-angle glaucoma: overview of its safety and efficacy	2
Emerging transcatheter heart valve technologies for severe aortic stenosis	2
The value of hip and knee arthroplasty registries	2
A novel design of low-cost hearing aid devices using an efficient lifting filter bank with a modified variable filter	1
Readmission rate and healthcare utilization outcomes of computer-assisted fluoroscopy-based hip navigation versus manual total hip arthroplasty	1
Comparison of the supraglottic airway device BlockBusterTM and laryngeal mask airway Supreme in anaesthetised, paralyzed adult patients: a multicenter randomized controlled trial	1
Preparing healthcare, academic institutions, and notified bodies for their involvement in the innovation of medical devices under the new European regulation	1
Radiofrequency spectroscopy with intraoperative pathological assessment for breast carcinoma: synergistic or redundant?	1
Feasibility of a wearable biosensor device to characterize exercise and sleep in neurology residents	1
Orphan and paediatric medical devices in Europe: recommendations to support their availability for on-label and off-label clinical indications	1
Comparison and convergence of compartment syndrome techniques: a narrative review	1
Computer-assisted surgery in medical and dental applications	1
Learning curve and factors influencing successful robot-assisted bilateral sentinel lymph node mapping in early-stage cervical cancer: an observational cohort study	1
Critical analysis of in vitro stability testing of spinal implants and proposal for standardization	1
Troubleshooting the difficult left ventricular lead placement in cardiac resynchronization therapy: current status and future perspectives	1
Could one strategy fit all? A comparison of regulatory guidance from China, Europe, and the USA on medical device clinical evaluation throughout the total product lifecycle	1
Device profile of the Orchid safety release valve for the prevention of accidental catheter dislodgement	1
Current status and prospects of robot-assisted spine surgery	1
Repeatability and reproducibility of the galilei G6 and its agreement with the pentacam® AXL in optical biometry and corneal tomography	1
Mobile applications in peripheral arterial disease (PAD): a review and introduction of a new innovative telemonitoring application: JBZetje	1
Leadless pacemaker versus transvenous single-chamber pacemaker therapy: peri-procedural aspects, utilization of medical resources and patient acceptance	1
Feasibility and patient’s experiences of perioperative telemonitoring in major abdominal surgery: an observational pilot study	1
Current status of biopsy markers for the breast in clinical settings	1
Focal therapy for localized cancer: a patent review	1
A systematic review of follow-up results of additively manufactured customized implants for the pelvic area	1
Review on the current treatment status of vein of Galen malformations and future directions in research and treatment	1
Patient-specific instrumentation makes sense in total knee arthroplasty	1
Through-the-needle biopsy of pancreatic cystic lesions: current evidence and implications for clinical practice	1
Assessment of patterns and predictors of medical device-related adverse events among oncology patients: a cross-sectional study at a tertiary care hospital	1
Optimizing the clinical adoption of total joint replacement of the lumbar spine through imaging, robotics and artificial intelligence	1
Remote monitoring of implantable electronic devices to predict heart failure decompensation	1
A narrative review of historic and current approaches for patients with difficult venous access: considerations for the emergency department	1