Expert Review of Medical Devices

Article	Citations
Single-pulse transcranial magnetic stimulation for assessment of motor development in infants with early brain injury	235
The Incraft stent graft for the treatment of abdominal aortic aneurysms: an iliac-friendly device with an effective conventional proximal sealing mechanism	79
The use of predetermined change control plans to enable the release of new versions of software as a medical device	59
Cataract surgery: historical devices, modern innovations, and future perspectives	38
Axial length measurement failure rates using optical biometry based on swept-source OCT in cataractous eyes	37
Advances in additive manufacturing processes and their use for the fabrication of lower limb prosthetic devices	35
Insertional effect following deep brain stimulation electrode implants	35
Penile compression devices for the treatment of urinary incontinence: current status and future prospects	35
COVID-19 lessons learned: medical devices at the core of global healthcare. A foreword on new challenges for expert review of medical devices!	33
Digital healthcare technologies: Modern tools to transform prosthetic care	33
Design of lower limb prosthetic sockets: a review	29
Ambient assisted living systems for falls monitoring at home	29
Ankle sprain bracing solutions and future design consideration for civilian and military use	28
The role of robotic technology in minimally invasive surgery for mitral valve disease	27
Deep brain stimulation programming strategies: segmented leads, independent current sources, and future technology	26
The current status of breakthrough devices designation in the United States and innovative medical devices designation in Korea for digital health software	24
RETRACTED ARTICLE: Anatomy of a Woebot® (WB001): agent guided CBT for women with postpartum depression	23
Advantages of three-photon live imaging for deep tissue analysis	22
Peritoneal dialysis catheter design and function and implications for the clinical setting	22
Consumer-facing and professional medical devices in cardiology: monitoring and evaluation of big data and the implications for the practice of cardiology	22
Clinician satisfaction and preference for central venous catheter systems promoting patient safety, ease-of-use and reduced clinician error	21
Ultra high-frequency ultrasound in lymphatic surgery: the next frontier	21
A review of transcranial pulse stimulation: innovations in neuromodulation	19
Artificial pancreas systems: experiences from concept to commercialisation	19
Clinical benefit of transcutaneous afferent patterned stimulation (TAPS) in essential tremor patients with high unmet need: a secondary analysis of TAPS studies	18

Redo aortic root – complexity vs simplicity with choice of device selected	18
Frozen elephant use in type a dissection: fundamentals, innovations, and pitfalls	18
A profile on the WISE cortical strip for intraoperative neurophysiological monitoring	18
Economic evaluation of automated external defibrillator deployment in public settings for out-of-hospital cardiac arrest: a systematic review	17
Device profile of the FlareHawk interbody fusion system, an endplate-conforming multi-planar expandable lumbar interbody fusion cage	16
Percutaneous auricular neuromodulation for postoperative analgesia	16
The ‘Japanese paradox’ of total hip arthroplasty: where are we going?	16
Peregrine system infusion catheter for neurolytic renal denervation in hypertension: an overview of its safety and efficacy	16
Device profile of the eversense continuous glucose monitoring system for glycemic control in type-1 diabetes: overview of its safety and efficacy	16
Toward applying a device to reduce motion artifact during imaging: a randomized controlled trial	15
Telemedicine for hypertension management: a paradigm shift from telemonitoring to digital therapeutics	14
Analysis of study designs and primary outcome measures in clinical trials of investigational suture materials	14
A randomized crossover comparison of the bébé VieScope and direct laryngoscope for pediatric airway management by nurses in medical simulation settings	14
Digital therapeutics as a new weapon against diseases: focus on the current European legislation and possible therapeutic strategies	14
An update on locoregional percutaneous treatment technologies in colorectal cancer liver metastatic disease	13
The Ovation Alto platform: extending endovascular treatment beyond short-necked abdominal aortic aneurysms	13
Intraosseous vascular access in emergency and trauma settings: a comparison of the most universally used intraosseous devices	13
Electromagnetic interference from automobile passive keyless entry in cardiovascular implantable electronic devices	13
Optimizing the clinical adoption of total joint replacement of the lumbar spine through imaging, robotics and artificial intelligence	12
A software-based lung function assessment tool: an interview with VoiceMed	12
MetaHealth: unlocking metaverse technologies in digital healthcare	12
Device profile of the Mobi-C artificial cervical disc: an overview of its safety and efficacy	12
The potential power of Neuralink – how brain-machine interfaces can revolutionize medicine	12
Robotic assistance in total knee arthroplasty surgery: necessity or trend?	12
Transforming medical education: the impact of innovations in technology and medical devices	12
Implantable medical devices for tendon and ligament repair: a review of patents and commercial products	12
Complications after peripherally inserted central catheter versus central venous catheter implantation in intensive care unit: propensity score analysis using a nationwide database	12
Randomized comparative study of negative pressure wound therapy versus compression dressing on split-thickness skin grafts of the lower limbs in an elderly population	11
Remote monitoring of implantable electronic devices to predict heart failure decompensation	11
Digital health; what do we mean by clinical validation?	11
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	11
Virtual reality therapy combined with physiological monitoring provides effective treatment, with objective metrics, for post-traumatic stress disorder	11
Radiofrequency spectroscopy with intraoperative pathological assessment for breast carcinoma: synergistic or redundant?	10
Proactive esophageal cooling during radiofrequency cardiac ablation: data update including applications in very high-power short duration ablation	10
Dynamic versus standard bougies for tracheal intubation with direct or indirect laryngoscopy in simulated or real scenarios: a systematic review and meta-analysis	10
Wearable electroencephalography for ultra-long-term seizure monitoring: a systematic review and future prospects	10
Correction	10
Revolutionizing breast cancer care: the synergy of AI-powered diagnostics, haptic-based biopsy simulators, and advanced surgical techniques	10
Device profile of the Orchid safety release valve for the prevention of accidental catheter dislodgement	10
Differentiating between hepatocellular carcinoma and its mimickers using contrast-enhanced ultrasound with perflubutane microbubbles	10
Utilization of preoperative EOS imaging to prevent adverse events following total hip arthroplasty	9
A pilot study of optical coherence tomography-guided transbronchial biopsy in peripheral pulmonary lesions	9
Lenstar LS900 vs EchoScan US-800: comparison between optical and ultrasound biometry with and without contact lenses and its relationship with other biometric parameters	9
Effectiveness of mental health chatbots in depression and anxiety for adolescents and young adults: a meta-analysis of randomized controlled trials	9
Device profile of the Evoke physiologic closed-loop spinal cord stimulation system for the treatment of chronic intractable pain: overview of its safety and efficacy	9
Artificially intelligent chatbots in digital mental health interventions: a review	9
Tumor treating fields for glioblastoma: opportunities and drawbacks	9
Can digital health help improve medication adherence in cardiovascular disease?	9
The transvaginal mesh: an overview of indications and contraindications for its use	9
Paired associative stimulation to enhance motor outcome in spinal cord injury: a systematic review of first evidence	8

Comments on: ‘Two-year outcomes using fast-acting sub-perception therapy for spinal cord stimulation: results of a real-world multicenter study in the United States’	8
What is the feasibility of a clinical-scale and anticoagulation-free artificial placenta device?	8
Test – re-test reliability and concurrent validity of cervical active range of motion in young asymptomatic adults using a new inertial measurement unit device	8
Comparative analysis of medical device adverse event reporting forms for patients and industries across various countries, and the introduction of a unified generic form for harmonization	8
Technological solution for the assessment and rehabilitation of visuo-cognition in Parkinson’s disease	8
Cardiac imaging for the detection of ischemia: current status and future perspectives	8
In vivo spectroscopy: optical fiber probes for clinical applications	8
Techniques in hybrid repair of aortic arch and thoracoabdominal aortic pathologies	8
Regulatory landscape, risks, and solutions for refurbished medical devices: a comparative analysis in the US, EU, Malaysia, and Ghana	8
Sacral neuromodulation for the treatment of overactive bladder: systematic review and future prospects	8
Profile of the Ovation ALTO abdominal stent graft for the treatment of abdominal aortic aneurysms: overview of its safety and efficacy	8
Multicenter randomized trial of carpal tunnel release with ultrasound guidance versus mini-open technique	7
Pulsed field ablation for atrial fibrillation	7
Therapeutic biliary stents: applications and opportunities	7
Long axial field-of-view PET/CT devices: are we ready for the technological revolution?	7
Mixed reality in interventional radiology: a focus on first clinical use of XR90 augmented reality-based visualization and navigation platform	7
Device evaluation: eCoin #x2013; implantable tibial nerve stimulator for overactive bladder	7
Continuous glucose monitoring in persons with type 2 diabetes not using insulin	6
Bone biopsy devices - a patent review	6
Hearables, in-ear sensing devices for bio-signal acquisition: a narrative review	6
Therapeutic prostate cancer interventions: a systematic review on pubic arch interference and needle positioning errors	6
Devices for osteoarthritis symptoms treatment: a patent review	6
Bridging the gap in the symptomatic heart failure patient journey: insights from the Italian scenario	6
Breaking the ice through an effective translationality in neurorehabilitation: are we heading to the right direction?	6
Selection criteria in the era of perfect competition for drug-eluting stents - a survey of interventional cardiologists in Japan: the selection-DES study	6
Modular cardiac rhythm management system and results of MODULAR ATP trial: an era of personalized device medicine	6
Resilient design: decentralized trials recovered faster from the impact of COVID-19 than traditional site-based designs	6
Evaluation of validity and reliability of novel rapid measurement for infundibulopelvic angle: a comparison with PACS system	6
When is a wearable defibrillator indicated?	6
Transperineal prostate biopsy using the PrecisionPoint Transperineal Access System for prostate cancer diagnosis – a new standard of care	6
A review: artificial intelligence in image-guided spinal surgery	6
Compatibility and durability of the gel stent material	6
Digital colposcopy image analysis techniques requirements and their role in clinical diagnosis: a systematic review	6
The role of feedback in the robotic-assisted upper limb rehabilitation in people with multiple sclerosis: a systematic review	6
Right heart failure after durable left ventricular assist device implantation	6
Advancing clinical understanding of surface electromyography biofeedback: bridging research, teaching, and commercial applications	6
Endocardial versus epicardial pacing in pacemaker-dependent patients after device extraction: a meta-analysis	6
Clinical study of real-time three-dimensional echocardiography combined with radionuclide imaging to evaluate changes in cardiac function and synchronization before and after cardiac rehabilitation in	6
Development and verification of a novel bone collector with automatic size separating function for orthopedics surgery	5
Legal and regulatory challenges in multi-country data-driven projects developing and validating medical AI systems in the EU	5
Addendum	5
Smart clothing for human movement analysis: future application in sport and clinical practice	5
Value of colposcopy with dynamic spectral imaging in the detection and evolution of high-grade cervical lesions	5
Limited value of current shoulder arthroplasty registries in evidence-based shoulder surgery: a review of 7 national registries	5
Endovascular reconstruction of the aortic arch with new-generation dual-branch and triple-branch endograft: design, applicability, indications, outcomes, and future directions	5
Advances in intravascular lithotripsy: mechanisms, devices, and clinical applications	5
Current development and clinical applications of artificial anal sphincter	5
Vascular access closure devices in neurointerventional procedures: current developments and future directions	5
Use of the PRECICE nail for distraction osteogenesis after tumor resection	5
Early revision events among patients with a three dimensional (3D) printed cellular titanium or PEEK (polyetheretherketone) spinal cage for single-level lumbar spinal fusion	5
Tests for the identification of reflex syncope mechanism	5
The frozen elephant trunk: an overview of hybrid prostheses	5
Relative utility of portable ECG devices in capturing arrhythmias in athletes	5
Meta-analysis of clinical outcomes in cardiac resynchronisation therapy: his bundle pacing vs biventricular pacing	5
Comparison of various video laryngoscopes for nasotracheal intubation in simulated difficult airway scenarios: a randomized self-controlled crossover trial	4
A systematic review of follow-up results of additively manufactured customized implants for the pelvic area	4
Letter to the editor on ‘the potential power of neuralink – how brain-machine interfaces can revolutionize medicine’	4
Profile of the Jada® System: the vacuum-induced hemorrhage control device for treating abnormal postpartum uterine bleeding and postpartum hemorrhage	4
Devices-based treatment of hypertension: the position of the European Society of Hypertension (ESH) 2023 guidelines	4
Anterior Segment Optical Coherence Tomography in Pediatric Ocular Pathology: Imaging Study of 115 eyes	4
Review of mechanisms of expandable spine surgery devices	4
Rehabilitation robotics after stroke: a bibliometric literature review	4
Evaluation and management of coronary artery disease in transcatheter aortic valve implantation candidates with severe aortic stenosis and coronary artery disease: technology and techniques	4
Intragastric balloons for obesity: critical review of device design, efficacy, tolerability, and unmet clinical needs	4
Assessing flow diverter porosity: a comparative analysis of quantification techniques based on imaging and simulation	4
RETRACTED ARTICLE : Comparison of supraglottic airway device vs. endotracheal intubation for initial airway management in out-of-hospital cardiac arrest: a systematic review and meta-analysis	4
Patient-specific instrumentation makes sense in total knee arthroplasty	4
Feasibility and patient’s experiences of perioperative telemonitoring in major abdominal surgery: an observational pilot study	4
Emerging technologies for combating pandemics	4
Two-year outcomes using fast-acting sub-perception therapy for spinal cord stimulation: results of a real-world multicenter study in the United States	4
Is open anterior advantageous to posterior decompression and reconstruction in fresh A 3 to C 3 /AO type thoracolumbar junction fr	4
Transcutaneous electric nerve stimulation in restless leg syndrome with cirrhosis: a pilot study	4
Visual performance during night driving after intraocular refractive surgery procedures	4
Anatomic feasibility of a novel modular triple-branched endograft for patients with aortic arch pathologies	4
HOPE for a better selection of patients for cardiac contractility modulation	4
Resource utilization and costs for robotic-assisted and manual total knee arthroplasty – a premier healthcare database study	4
Is there a role for continuous glucose monitoring beyond diabetes? Emerging applications in new populations	4
A comparative study of medical device regulation between countries based on their economies	4
Prevention of prosthetic joint infection/surgical site infection: what did the International Consensus Meeting decide?	4
Ventricular tachycardia ablation as an alternative to implantable cardioverter-defibrillators in patients with preserved ejection fraction: current status and future prospects	4

The CardioMEMS Heart Failure System for chronic heart failure – a European perspective	3
Atrial flow regulators for the treatment of pulmonary arterial hypertension: what does the future hold?	3
Noninvasive vagus nerve stimulation in Parkinson’s disease: current status and future prospects	3
Emergency provider preference for powered intraosseous devices and satisfaction with features improving safety, reliability, and ease-of-use	3
Prognostic value of renal failure in patients undergoing transvenous lead extraction: single centre experience and systematic review of the literature	3
Test-retest reliability of pain extent and pain location using a novel pain drawing analysis software application, on patients with shoulder pain	3
Histological examination of tooth-derived biomaterials obtained from different devices	3
A review of arrhythmia detection based on electrocardiogram with artificial intelligence	3
Current and future directions for the use of handheld fundus cameras in telehealth	3
Usefulness of insertable cardiac monitors for risk stratification: current indications and clinical evidence	3
Preparing for the new wave of intrathecal CNS therapies: innovations in drug delivery devices	3
Hydrophilic biomaterial intravenous hydrogel catheter for complication reduction in PICC and midline catheters	3
Minimally invasive capillary blood sampling methods	3
Appropriate use criteria of left atrial appendage closure devices: latest evidences	3
Assessment of microcirculatory alteration by a vascular occlusion test using near-infrared spectroscopy in pediatric cardiac surgery: effect of cardiopulmonary bypass	3
American and European legislation on border medical devices	3
Robotic navigation during spine surgery: an update of literature	3
Efficacy of LMA gastro airway versus endotracheal tube for therapeutic endoscopic retrograde cholangiopancreatography under general anesthesia: a randomized trial	3
The evolving role of real-world evidence in medical device approvals in the United States	3
Treatment of brief episodes of highly symptomatic supraventricular and ventricular arrhythmias: a methodological review	3
Deep brain stimulation for Alzheimer’s disease – current status and next steps	3
Updates in immunocompatibility of biomaterials: applications for regenerative medicine	3
Uniportal versus biportal endoscopic spine surgery: a comprehensive review	3
Indications and outcomes of revision total ankle arthroplasty	3
GI genius endoscopy module: a clinical profile	3
From plugging air leaks to reducing lung volume: a review of the many uses of endobronchial valves	3
Diagnostic value of 24-hour Holter monitoring and conventional electrocardiogram in arrhythmia	3
Low profile endografts for the endovascular treatment of abdominal aortic aneurysms	3
The current use of tissue expanders in breast reconstruction: device design, features, and technical considerations	3
Ablate and pace strategy for atrial fibrillation: pacing modalities, ablation approaches and impact on patient outcomes	3
Outcomes and evaluation of endoscopic retrograde cholangiopancreatography via Gastro-Laryngeal Tube in adult patients: a prospective randomised control study	3
A retrospective study of reported adverse events associated with cardiac stents in Indian population	3
Effectiveness and safety of implantable loop recorder and clinical utility of remote monitoring in patients with unexplained, recurrent, traumatic syncope	3
Comparison of 6-lead smartphone ECG and 12-lead ECG in athletes and a genetic heart disease population	3
Development of theranostic wound dressings: harnessing the knowledge of biospecific interactions at the biomaterial interface to promote healing and identify biomarkers	3
Magnetic resonance-guided ultrasound thalamotomy for essential tremor: a review	3
Utility of Acquire 22G-fine needle biopsy (FNB) needle vs the standard 22G needle during Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA): A Randomized Controlled Trial (RC	3
99m Tc-labeled and functionalised plasmonic nanoparticles for photo-thermal therapy of primary tumours	3
Investigation of the effectiveness of interactive telerehabilitation and transcutaneous electrical nerve stimulation on pain, functionality, disability and quality of life in patients with nonspecific	3
S-ICDs: advantages and opportunities for improvement	3
Device profile of the iTind temporary implantable nitinol device for benign prostatic hyperplasia	3
Interaction between maintenance variables of medical ultrasound scanners through multifactor dimensionality reduction	2
Readmission rate and healthcare utilization outcomes of computer-assisted fluoroscopy-based hip navigation versus manual total hip arthroplasty	2
Comparison of the supraglottic airway device BlockBusterTM and laryngeal mask airway Supreme in anaesthetised, paralyzed adult patients: a multicenter randomized controlled trial	2
Statement of Retraction : Comparison of supraglottic airway device vs. endotracheal intubation for initial airway management in out-of-hospital cardiac arrest: a systematic review and meta-analysis	2
Wearable inertial sensors for human movement analysis: a five-year update	2
Navigating hypotony challenges with XEN gel implantation	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
The modern pharmacological approach to diabetes: innovative methods of monitoring and insulin treatment	2
Determinants of return to activity and work after carpal tunnel release: a systematic review and meta-analysis	2
Device profile of the Zephyr endobronchial valve in heterogenous emphysema: overview of its safety and efficacy	2
Evaluations of medical device usability during clinical investigations: a scoping review of clinical study protocols	2
Biomaterial engineering surface to control polymicrobial dental implant-related infections: focusing on disease modulating factors and coatings development	2
A profile on the CardioMEMS HF system in the management of patients with early stages of heart failure: an update	2
The E-nside, multi-inner branch-based off-the-shelf stent graft for the treatment of thoracoabdominal aortic aneurysms	2
Comparison of clinical efficacy of three different dentin matrix biomaterials obtained from different devices	2
The added value of lung perfusion scintigraphy semiquantitative measures in post-COVID patients with persistent dyspnea without pulmonary embolism	2
Design trends in actuated lower-limb prosthetic systems: a narrative review	2
Is conduction system pacing a panacea for pacemaker therapy?	2
Comparative study of biomodels manufactured using 3D printing techniques for surgical planning and medical training	2
Recent advances in the use of ultrasound in Crohn’s disease	2
Immune responses to implants: how can they be anticipated and managed?	2
Is there a best choice of equipment for colorectal endoscopic submucosal dissection?	2
Chronic electroencephalography in epilepsy with a responsive neurostimulation device: current status and future prospects	2
A post-market, randomized, controlled, prospective study evaluating intrathecal pain medication versus conventional medical management in the non-cancer, refractory, chronic pain population (PROSPER)	2
Hospital medical device quality and safety monitoring using real-world data from Friuli Venezia Giulia regional health coordination agency	2
Antithrombotic therapy after transcatheter aortic valve implantation	2
Device profile of EndoAnchors for aortic stent graft implantation: overview of their safety and efficacy	2
Closed-loop systems for deep brain stimulation to treat neuropsychiatric disorders	2
A novel design of low-cost hearing aid devices using an efficient lifting filter bank with a modified variable filter	2
Critical analysis of in vitro stability testing of spinal implants and proposal for standardization	2
Ceramic-based 3D printed bone graft in bone tissue reconstruction: a systematic review and proportional meta-analysis of clinical studies	2
Comparison and convergence of compartment syndrome techniques: a narrative review	2
Transcranial direct current stimulation combined with peripheral stimulation in chronic pain: a systematic review and meta-analysis	2
Current status and prospects of robot-assisted spine surgery	2
Diaphragm neurostimulation in mechanical ventilation: current status and future prospects	2
How robotic platforms are revolutionizing colorectal surgery techniques: a comparative review	2
Emerging transcatheter heart valve technologies for severe aortic stenosis	2
Sex differences in 123I-mIBG scintigraphy imaging techniques in patients with heart failure	2
Safety and effectiveness of left atrial appendage closure in patients with non-valvular atrial fibrillation and prior major bleeding	2
Hydrus microstent for the treatment of primary open-angle glaucoma: overview of its safety and efficacy	2
Focused ultrasound: focused on tremor	2
Future perspectives and challenges of artificial intelligence implementation in remote monitoring of cardiac implantable electronic devices	2
A comparative study of regulatory perspectives on innovative medical devices in Korea and the United States	1
Vecto-keratometry: determination of anterior corneal astigmatism in manual keratometers using power vectors	1
Current status of biopsy markers for the breast in clinical settings	1
A comparison of endotracheal intubation characteristics between Macintosh, CMAC, and Smart Trach Video laryngoscope: a randomized prospective clinical trial	1
Application of intrauterine balloons in cervical ripening	1
His bundle pacing combined with atrioventricular node ablation for atrial fibrillation: a systematic review and meta-analysis	1
Developing a training for 3D transrectal multiparametric ultrasound of the prostate: a human factors engineering approach	1
How can we develop transcranial direct current stimulation into an effective at-home treatment tool for depression?	1
Clinical effect of using a lower limb warming blanket combined with dexmedetomidine to prevent postoperative delirium and shivering in elderly patients undergoing spinal surgery	1
Medical device regulation in vascular ageing assessment: a VascAgeNet survey exploring knowledge and perception	1
Quantifying insertional effects in deep brain stimulation: clinical outcomes and neurophysiological mechanisms	1
Letter to the editor in response to: A profile on the WISE cortical strip for intraoperative neurophysiological monitoring	1