Expert Review of Medical Devices

Article	Citations
Single-pulse transcranial magnetic stimulation for assessment of motor development in infants with early brain injury	206
The Incraft stent graft for the treatment of abdominal aortic aneurysms: an iliac-friendly device with an effective conventional proximal sealing mechanism	73
The use of predetermined change control plans to enable the release of new versions of software as a medical device	53
Cataract surgery: historical devices, modern innovations, and future perspectives	37
Axial length measurement failure rates using optical biometry based on swept-source OCT in cataractous eyes	37
Insertional effect following deep brain stimulation electrode implants	35
The role of robotic technology in minimally invasive surgery for mitral valve disease	33
Penile compression devices for the treatment of urinary incontinence: current status and future prospects	32
Digital healthcare technologies: Modern tools to transform prosthetic care	29
COVID-19 lessons learned: medical devices at the core of global healthcare. A foreword on new challenges for expert review of medical devices!	29
Ambient assisted living systems for falls monitoring at home	28
Advances in additive manufacturing processes and their use for the fabrication of lower limb prosthetic devices	28
Deep brain stimulation programming strategies: segmented leads, independent current sources, and future technology	26
Consumer-facing and professional medical devices in cardiology: monitoring and evaluation of big data and the implications for the practice of cardiology	25
Design of lower limb prosthetic sockets: a review	25
The current status of breakthrough devices designation in the United States and innovative medical devices designation in Korea for digital health software	25
Ankle sprain bracing solutions and future design consideration for civilian and military use	24
RETRACTED ARTICLE: Anatomy of a Woebot® (WB001): agent guided CBT for women with postpartum depression	23
Peritoneal dialysis catheter design and function and implications for the clinical setting	21
Clinician satisfaction and preference for central venous catheter systems promoting patient safety, ease-of-use and reduced clinician error	20
Ultra high-frequency ultrasound in lymphatic surgery: the next frontier	20
Device profile of the FlareHawk interbody fusion system, an endplate-conforming multi-planar expandable lumbar interbody fusion cage	19
Redo aortic root – complexity vs simplicity with choice of device selected	19
The ‘Japanese paradox’ of total hip arthroplasty: where are we going?	18
Artificial pancreas systems: experiences from concept to commercialisation	18

A profile on the WISE cortical strip for intraoperative neurophysiological monitoring	18
Frozen elephant use in type a dissection: fundamentals, innovations, and pitfalls	18
Economic evaluation of automated external defibrillator deployment in public settings for out-of-hospital cardiac arrest: a systematic review	17
Clinical benefit of transcutaneous afferent patterned stimulation (TAPS) in essential tremor patients with high unmet need: a secondary analysis of TAPS studies	17
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
Percutaneous auricular neuromodulation for postoperative analgesia	16
Digital therapeutics as a new weapon against diseases: focus on the current European legislation and possible therapeutic strategies	15
The potential power of Neuralink – how brain-machine interfaces can revolutionize medicine	15
A randomized crossover comparison of the bébé VieScope and direct laryngoscope for pediatric airway management by nurses in medical simulation settings	14
Telemedicine for hypertension management: a paradigm shift from telemonitoring to digital therapeutics	14
Toward applying a device to reduce motion artifact during imaging: a randomized controlled trial	14
Analysis of study designs and primary outcome measures in clinical trials of investigational suture materials	14
Transforming medical education: the impact of innovations in technology and medical devices	14
Electromagnetic interference from automobile passive keyless entry in cardiovascular implantable electronic devices	13
Potential strategies to prevent encrustations on urinary stents and catheters – thinking outside the box: a European network of multidisciplinary research to improve urinary stents (ENIUS) initiative	13
The Ovation Alto platform: extending endovascular treatment beyond short-necked abdominal aortic aneurysms	13
Complications after peripherally inserted central catheter versus central venous catheter implantation in intensive care unit: propensity score analysis using a nationwide database	13
Intraosseous vascular access in emergency and trauma settings: a comparison of the most universally used intraosseous devices	12
Implantable medical devices for tendon and ligament repair: a review of patents and commercial products	12
Device profile of the Mobi-C artificial cervical disc: an overview of its safety and efficacy	12
Optimizing the clinical adoption of total joint replacement of the lumbar spine through imaging, robotics and artificial intelligence	12
Robotic assistance in total knee arthroplasty surgery: necessity or trend?	12
An update on locoregional percutaneous treatment technologies in colorectal cancer liver metastatic disease	12
MetaHealth: unlocking metaverse technologies in digital healthcare	12
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
Remote monitoring of implantable electronic devices to predict heart failure decompensation	11
Randomized comparative study of negative pressure wound therapy versus compression dressing on split-thickness skin grafts of the lower limbs in an elderly population	10
Role of real-world digital data for orthopedic implant automated surveillance: a systematic review	10
Device profile of the Orchid safety release valve for the prevention of accidental catheter dislodgement	10
Wearable electroencephalography for ultra-long-term seizure monitoring: a systematic review and future prospects	10
Radiofrequency spectroscopy with intraoperative pathological assessment for breast carcinoma: synergistic or redundant?	10
Endovascular treatment of extracranial carotid artery stenosis using a dual-layer micromesh stents: a systematic review	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
Digital health; what do we mean by clinical validation?	10
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
Correction	9
Differentiating between hepatocellular carcinoma and its mimickers using contrast-enhanced ultrasound with perflubutane microbubbles	9
Effectiveness of mental health chatbots in depression and anxiety for adolescents and young adults: a meta-analysis of randomized controlled trials	9
Proactive esophageal cooling during radiofrequency cardiac ablation: data update including applications in very high-power short duration ablation	9
A pilot study of optical coherence tomography-guided transbronchial biopsy in peripheral pulmonary lesions	9
Utilization of preoperative EOS imaging to prevent adverse events following total hip arthroplasty	9
Revolutionizing breast cancer care: the synergy of AI-powered diagnostics, haptic-based biopsy simulators, and advanced surgical techniques	9
The transvaginal mesh: an overview of indications and contraindications for its use	8
Artificially intelligent chatbots in digital mental health interventions: a review	8
In vivo spectroscopy: optical fiber probes for clinical applications	8
Can digital health help improve medication adherence in cardiovascular disease?	8
The evolution of long-term pediatric ventricular assistance devices: a critical review	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

Techniques in hybrid repair of aortic arch and thoracoabdominal aortic pathologies	8
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	8
What is the feasibility of a clinical-scale and anticoagulation-free artificial placenta device?	8
Cardiac imaging for the detection of ischemia: current status and future perspectives	8
Sacral neuromodulation for the treatment of overactive bladder: systematic review and future prospects	7
Regulatory landscape, risks, and solutions for refurbished medical devices: a comparative analysis in the US, EU, Malaysia, and Ghana	7
Mixed reality in interventional radiology: a focus on first clinical use of XR90 augmented reality-based visualization and navigation platform	7
Profile of the Ovation ALTO abdominal stent graft for the treatment of abdominal aortic aneurysms: overview of its safety and efficacy	7
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’	7
Technological solution for the assessment and rehabilitation of visuo-cognition in Parkinson’s disease	7
Therapeutic biliary stents: applications and opportunities	7
Device evaluation: eCoin #x2013; implantable tibial nerve stimulator for overactive bladder	7
Test – re-test reliability and concurrent validity of cervical active range of motion in young asymptomatic adults using a new inertial measurement unit device	7
Paired associative stimulation to enhance motor outcome in spinal cord injury: a systematic review of first evidence	7
Multicenter randomized trial of carpal tunnel release with ultrasound guidance versus mini-open technique	7
Evaluation of validity and reliability of novel rapid measurement for infundibulopelvic angle: a comparison with PACS system	7
Modular cardiac rhythm management system and results of MODULAR ATP trial: an era of personalized device medicine	6
Advancing clinical understanding of surface electromyography biofeedback: bridging research, teaching, and commercial applications	6
The role of feedback in the robotic-assisted upper limb rehabilitation in people with multiple sclerosis: a systematic review	6
Long axial field-of-view PET/CT devices: are we ready for the technological revolution?	6
Devices for osteoarthritis symptoms treatment: a patent review	6
Advances in intravascular lithotripsy: mechanisms, devices, and clinical applications	6
Transperineal prostate biopsy using the PrecisionPoint Transperineal Access System for prostate cancer diagnosis – a new standard of care	6
Resilient design: decentralized trials recovered faster from the impact of COVID-19 than traditional site-based designs	6
Bone biopsy devices - a patent review	6
Hearables, in-ear sensing devices for bio-signal acquisition: a narrative review	6
Digital colposcopy image analysis techniques requirements and their role in clinical diagnosis: a systematic review	6
Endovascular reconstruction of the aortic arch with new-generation dual-branch and triple-branch endograft: design, applicability, indications, outcomes, and future directions	6
Development and verification of a novel bone collector with automatic size separating function for orthopedics surgery	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
Right heart failure after durable left ventricular assist device implantation	6
Pulsed field ablation for atrial fibrillation	6
Devices for transcatheter mitral valve repair: current technology and a glimpse into the future	6
A review: artificial intelligence in image-guided spinal surgery	6
The frozen elephant trunk: an overview of hybrid prostheses	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
Therapeutic prostate cancer interventions: a systematic review on pubic arch interference and needle positioning errors	6
Relative utility of portable ECG devices in capturing arrhythmias in athletes	5
Value of colposcopy with dynamic spectral imaging in the detection and evolution of high-grade cervical lesions	5
Vascular access closure devices in neurointerventional procedures: current developments and future directions	5
Breaking the ice through an effective translationality in neurorehabilitation: are we heading to the right direction?	5
Compatibility and durability of the gel stent material	5
When is a wearable defibrillator indicated?	5
Addendum	5
Smart clothing for human movement analysis: future application in sport and clinical practice	5
Use of the PRECICE nail for distraction osteogenesis after tumor resection	5
Transcutaneous electric nerve stimulation in restless leg syndrome with cirrhosis: a pilot study	5
Tests for the identification of reflex syncope mechanism	5
Endocardial versus epicardial pacing in pacemaker-dependent patients after device extraction: a meta-analysis	5
Limited value of current shoulder arthroplasty registries in evidence-based shoulder surgery: a review of 7 national registries	5
BComparison of supraglottic airway device vs. endotracheal intubation for initial airway management in out-of-hospital cardiac arrest: a systematic review and meta-analysis	5
Meta-analysis of clinical outcomes in cardiac resynchronisation therapy: his bundle pacing vs biventricular pacing	5
Optimizer Smart System for the treatment of chronic heart failure: Overview of its safety and efficacy	5
Current development and clinical applications of artificial anal sphincter	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
Continuous glucose monitoring in persons with type 2 diabetes not using insulin	5
Bridging the gap in the symptomatic heart failure patient journey: insights from the Italian scenario	5
Comparison of various video laryngoscopes for nasotracheal intubation in simulated difficult airway scenarios: a randomized self-controlled crossover trial	4
Assessing flow diverter porosity: a comparative analysis of quantification techniques based on imaging and simulation	4
A systematic review of follow-up results of additively manufactured customized implants for the pelvic area	4
Computer-assisted surgery in medical and dental applications	4
Is there a role for continuous glucose monitoring beyond diabetes? Emerging applications in new populations	4
Minimally invasive capillary blood sampling methods	4
Rehabilitation robotics after stroke: a bibliometric literature review	4
Devices-based treatment of hypertension: the position of the European Society of Hypertension (ESH) 2023 guidelines	4
HOPE for a better selection of patients for cardiac contractility modulation	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
Is open anterior advantageous to posterior decompression and reconstruction in fresh A 3 to C 3 /AO type thoracolumbar junction fr	4
Intragastric balloons for obesity: critical review of device design, efficacy, tolerability, and unmet clinical needs	4
Robotic navigation during spine surgery: an update of literature	4
Review of mechanisms of expandable spine surgery devices	4
Assessment of microcirculatory alteration by a vascular occlusion test using near-infrared spectroscopy in pediatric cardiac surgery: effect of cardiopulmonary bypass	4
Visual performance during night driving after intraocular refractive surgery procedures	4
Feasibility and patient’s experiences of perioperative telemonitoring in major abdominal surgery: an observational pilot study	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
Anatomic feasibility of a novel modular triple-branched endograft for patients with aortic arch pathologies	4
Resource utilization and costs for robotic-assisted and manual total knee arthroplasty – a premier healthcare database study	4
Profile of the Jada® System: the vacuum-induced hemorrhage control device for treating abnormal postpartum uterine bleeding and postpartum hemorrhage	4
Preparing for the new wave of intrathecal CNS therapies: innovations in drug delivery devices	4
Anterior Segment Optical Coherence Tomography in Pediatric Ocular Pathology: Imaging Study of 115 eyes	4

Ventricular tachycardia ablation as an alternative to implantable cardioverter-defibrillators in patients with preserved ejection fraction: current status and future prospects	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
Patient-specific instrumentation makes sense in total knee arthroplasty	4
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
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
Axonics® system for treatment of overactive bladder syndrome and urinary urgency incontinence	3
Usefulness of insertable cardiac monitors for risk stratification: current indications and clinical evidence	3
99m Tc-labeled and functionalised plasmonic nanoparticles for photo-thermal therapy of primary tumours	3
Development of theranostic wound dressings: harnessing the knowledge of biospecific interactions at the biomaterial interface to promote healing and identify biomarkers	3
S-ICDs: advantages and opportunities for improvement	3
Low profile endografts for the endovascular treatment of abdominal aortic aneurysms	3
Effectiveness and safety of implantable loop recorder and clinical utility of remote monitoring in patients with unexplained, recurrent, traumatic syncope	3
Efficacy of LMA gastro airway versus endotracheal tube for therapeutic endoscopic retrograde cholangiopancreatography under general anesthesia: a randomized trial	3
Prognostic value of renal failure in patients undergoing transvenous lead extraction: single centre experience and systematic review of the literature	3
Emerging technologies for combating pandemics	3
Outcomes and evaluation of endoscopic retrograde cholangiopancreatography via Gastro-Laryngeal Tube in adult patients: a prospective randomised control study	3
Diagnostic value of 24-hour holter monitoring and conventional electrocardiogram in arrhythmia	3
Device profile of the tack endovascular system® for the treatment of peripheral arterial disease: overview of safety and efficacy	3
A retrospective study of reported adverse events associated with cardiac stents in Indian population	3
Comparison of 6-lead smartphone ECG and 12-lead ECG in athletes and a genetic heart disease population	3
A review of arrhythmia detection based on electrocardiogram with artificial intelligence	3
From plugging air leaks to reducing lung volume: a review of the many uses of endobronchial valves	3
Histological examination of tooth-derived biomaterials obtained from different devices	3
Truss implant technology™ for interbody fusion in spinal degenerative disorders: profile of advanced structural design, mechanobiologic and performance characteristics	3
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
Transcatheter valve-in-valve implantation for degenerated bioprosthetic aortic and mitral valves – an update on indications, techniques, and clinical results	3
Uniportal versus biportal endoscopic spine surgery: a comprehensive review	3
US Guided Si.La.D. A new technique for minimally invasive pilonidal disease treatment, using ultrasound guided laser ablation	3
GI genius endoscopy module: a clinical profile	3
Emergency provider preference for powered intraosseous devices and satisfaction with features improving safety, reliability, and ease-of-use	3
Noninvasive vagus nerve stimulation in Parkinson’s disease: current status and future prospects	3
Treatment of brief episodes of highly symptomatic supraventricular and ventricular arrhythmias: a methodological review	3
Hydrophilic biomaterial intravenous hydrogel catheter for complication reduction in PICC and midline catheters	3
Indications and outcomes of revision total ankle arthroplasty	3
Updates in immunocompatibility of biomaterials: applications for regenerative medicine	3
Deep brain stimulation for Alzheimer’s disease – current status and next steps	3
Appropriate use criteria of left atrial appendage closure devices: latest evidences	3
American and European legislation on border medical devices	3
Current and future directions for the use of handheld fundus cameras in telehealth	3
The evolving role of real-world evidence in medical device approvals in the United States	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
Hydrus microstent for the treatment of primary open-angle glaucoma: overview of its safety and efficacy	2
Comparison of the supraglottic airway device BlockBusterTM and laryngeal mask airway Supreme in anaesthetised, paralyzed adult patients: a multicenter randomized controlled trial	2
Recent advances in the use of ultrasound in Crohn’s disease	2
Design trends in actuated lower-limb prosthetic systems: a narrative review	2
A profile on the CardioMEMS HF system in the management of patients with early stages of heart failure: an update	2
Comparative study of biomodels manufactured using 3D printing techniques for surgical planning and medical training	2
Ceramic-based 3D printed bone graft in bone tissue reconstruction: a systematic review and proportional meta-analysis of clinical studies	2
Biomaterial engineering surface to control polymicrobial dental implant-related infections: focusing on disease modulating factors and coatings development	2
Test-retest reliability of pain extent and pain location using a novel pain drawing analysis software application, on patients with shoulder pain	2
Focused ultrasound: focused on tremor	2
Is conduction system pacing a panacea for pacemaker therapy?	2
Current status and prospects of robot-assisted spine surgery	2
The added value of lung perfusion scintigraphy semiquantitative measures in post-COVID patients with persistent dyspnea without pulmonary embolism	2
Immune responses to implants: how can they be anticipated and managed?	2
Comparison and convergence of compartment syndrome techniques: a narrative review	2
Navigating hypotony challenges with XEN gel implantation	2
Device profile of EndoAnchors for aortic stent graft implantation: overview of their safety and efficacy	2
Chronic electroencephalography in epilepsy with a responsive neurostimulation device: current status and future prospects	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
Transcranial direct current stimulation combined with peripheral stimulation in chronic pain: a systematic review and meta-analysis	2
Caloric and galvanic vestibular stimulation for the treatment of Parkinson’s disease: rationale and prospects	2
Evaluations of medical device usability during clinical investigations: a scoping review of clinical study protocols	2
Hospital medical device quality and safety monitoring using real-world data from Friuli Venezia Giulia regional health coordination agency	2
Is there a best choice of equipment for colorectal endoscopic submucosal dissection?	2
Sex differences in 123I-mIBG scintigraphy imaging techniques in patients with heart failure	2
Critical analysis of in vitro stability testing of spinal implants and proposal for standardization	2
Wearable inertial sensors for human movement analysis: a five-year update	2
Diaphragm neurostimulation in mechanical ventilation: current status and future prospects	2
Emerging transcatheter heart valve technologies for severe aortic stenosis	2
Antithrombotic therapy after transcatheter aortic valve implantation	2
Device profile of the Zephyr endobronchial valve in heterogenous emphysema: overview of its safety and efficacy	2
Mobile applications in peripheral arterial disease (PAD): a review and introduction of a new innovative telemonitoring application: JBZetje	2
How robotic platforms are revolutionizing colorectal surgery techniques: a comparative review	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
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
Safety and effectiveness of left atrial appendage closure in patients with non-valvular atrial fibrillation and prior major bleeding	2
How to assess the risks associated with the usage of a medical device based on predictive modeling: the case of an anemia control model certified as medical device	1
Video laryngeal masks in airway management	1
Music-based techniques and related devices in neurorehabilitation: a scoping review	1
Troubleshooting the difficult left ventricular lead placement in cardiac resynchronization therapy: current status and future perspectives	1
Recent advances in devices and technologies that might prove revolutionary for colonoscopy procedures	1
Advances in the measurement of prosthetic socket interface mechanics: a review of technology, techniques, and a 20-year update	1
Procedural embolic protection strategies for carotid artery stenting: current status and future prospects	1
Transcranial magnetic resonance imaging–guided focused ultrasound for neuropathic pain treatment	1
How can we develop transcranial direct current stimulation into an effective at-home treatment tool for depression?	1
Anticipating and preventing complications in spinal cord stimulator implantation	1
Orphan and paediatric medical devices in Europe: recommendations to support their availability for on-label and off-label clinical indications	1
Repeatability and reproducibility of the galilei G6 and its agreement with the pentacam® AXL in optical biometry and corneal tomography	1
Surface modification of ureteral stents: development history, classification, function, and future developments	1
Technologies and devices for preventing coronary obstruction during TAVR procedure	1