Expert Review of Medical Devices

Article	Citations
Axial length measurement failure rates using optical biometry based on swept-source OCT in cataractous eyes	267
Cataract surgery: historical devices, modern innovations, and future perspectives	66
Advantages of three-photon live imaging for deep tissue analysis	45
The Incraft stent graft for the treatment of abdominal aortic aneurysms: an iliac-friendly device with an effective conventional proximal sealing mechanism	39
The current status of breakthrough devices designation in the United States and innovative medical devices designation in Korea for digital health software	38
Single-pulse transcranial magnetic stimulation for assessment of motor development in infants with early brain injury	38
Design of lower limb prosthetic sockets: a review	37
Consumer-facing and professional medical devices in cardiology: monitoring and evaluation of big data and the implications for the practice of cardiology	36
RETRACTED ARTICLE: Anatomy of a Woebot® (WB001): agent guided CBT for women with postpartum depression	33
Ankle sprain bracing solutions and future design consideration for civilian and military use	32
Insertional effect following deep brain stimulation electrode implants	31
COVID-19 lessons learned: medical devices at the core of global healthcare. A foreword on new challenges for expert review of medical devices!	30
Ambient assisted living systems for falls monitoring at home	25
Penile compression devices for the treatment of urinary incontinence: current status and future prospects	25
Advances in additive manufacturing processes and their use for the fabrication of lower limb prosthetic devices	25
The use of predetermined change control plans to enable the release of new versions of software as a medical device	24
Peritoneal dialysis catheter design and function and implications for the clinical setting	23
Frozen elephant use in type a dissection: fundamentals, innovations, and pitfalls	22
Clinical benefit of transcutaneous afferent patterned stimulation (TAPS) in essential tremor patients with high unmet need: a secondary analysis of TAPS studies	21
Economic evaluation of automated external defibrillator deployment in public settings for out-of-hospital cardiac arrest: a systematic review	21
A profile on the WISE cortical strip for intraoperative neurophysiological monitoring	20
A review of transcranial pulse stimulation: innovations in neuromodulation	18
Artificial pancreas systems: experiences from concept to commercialisation	18
Clinician satisfaction and preference for central venous catheter systems promoting patient safety, ease-of-use and reduced clinician error	18
Redo aortic root – complexity vs simplicity with choice of device selected	18

Optimizing atrial fibrillation detection: a review of subcutaneous cardiac rhythm monitors and consumer technologies	17
Ultra high-frequency ultrasound in lymphatic surgery: the next frontier	17
The ‘Japanese paradox’ of total hip arthroplasty: where are we going?	16
Device profile of the FlareHawk interbody fusion system, an endplate-conforming multi-planar expandable lumbar interbody fusion cage	16
Peregrine system infusion catheter for neurolytic renal denervation in hypertension: an overview of its safety and efficacy	15
Percutaneous auricular neuromodulation for postoperative analgesia	15
Digital therapeutics as a new weapon against diseases: focus on the current European legislation and possible therapeutic strategies	15
A software-based lung function assessment tool: an interview with VoiceMed	14
Electromagnetic interference from automobile passive keyless entry in cardiovascular implantable electronic devices	14
Robotic assistance in total knee arthroplasty surgery: necessity or trend?	14
Optimizing the clinical adoption of total joint replacement of the lumbar spine through imaging, robotics and artificial intelligence	14
Analysis of study designs and primary outcome measures in clinical trials of investigational suture materials	14
Device profile of the Mobi-C artificial cervical disc: an overview of its safety and efficacy	14
A randomized crossover comparison of the bébé VieScope and direct laryngoscope for pediatric airway management by nurses in medical simulation settings	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
An update on locoregional percutaneous treatment technologies in colorectal cancer liver metastatic disease	13
Toward applying a device to reduce motion artifact during imaging: a randomized controlled trial	13
Telemedicine for hypertension management: a paradigm shift from telemonitoring to digital therapeutics	13
Implantable medical devices for tendon and ligament repair: a review of patents and commercial products	13
A review on the impact of cardiac pacing on right ventricular and tricuspid valve function	13
Dynamic versus standard bougies for tracheal intubation with direct or indirect laryngoscopy in simulated or real scenarios: a systematic review and meta-analysis	12
Digital health; what do we mean by clinical validation?	12
Transforming medical education: the impact of innovations in technology and medical devices	12
Wearable electroencephalography for ultra-long-term seizure monitoring: a systematic review and future prospects	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	12
The potential power of Neuralink – how brain-machine interfaces can revolutionize medicine	12
Differentiating between hepatocellular carcinoma and its mimickers using contrast-enhanced ultrasound with perflubutane microbubbles	11
Virtual reality therapy combined with physiological monitoring provides effective treatment, with objective metrics, for post-traumatic stress disorder	11
Device profile of the Orchid safety release valve for the prevention of accidental catheter dislodgement	11
Remote monitoring of implantable electronic devices to predict heart failure decompensation	11
Revolutionizing breast cancer care: the synergy of AI-powered diagnostics, haptic-based biopsy simulators, and advanced surgical techniques	11
Radiofrequency spectroscopy with intraoperative pathological assessment for breast carcinoma: synergistic or redundant?	11
Proactive esophageal cooling during radiofrequency cardiac ablation: data update including applications in very high-power short duration ablation	10
Tumor treating fields for glioblastoma: opportunities and drawbacks	10
Utilization of preoperative EOS imaging to prevent adverse events following total hip arthroplasty	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	10
Effectiveness of mental health chatbots in depression and anxiety for adolescents and young adults: a meta-analysis of randomized controlled trials	10
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
Can digital health help improve medication adherence in cardiovascular disease?	10
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	10
Correction	10
A pilot study of optical coherence tomography-guided transbronchial biopsy in peripheral pulmonary lesions	9
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	9
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’	9
Paired associative stimulation to enhance motor outcome in spinal cord injury: a systematic review of first evidence	9
The transvaginal mesh: an overview of indications and contraindications for its use	9
Artificially intelligent chatbots in digital mental health interventions: a review	9
Profile of the Ovation ALTO abdominal stent graft for the treatment of abdominal aortic aneurysms: overview of its safety and efficacy	8

Comparison of laryngeal exposure in bed-up-head-elevated Macintosh laryngoscopy vs. supine C-MAC video laryngoscopy: a randomized non-inferiority trial	8
Regulatory landscape, risks, and solutions for refurbished medical devices: a comparative analysis in the US, EU, Malaysia, and Ghana	8
Cardiac imaging for the detection of ischemia: current status and future perspectives	8
In vivo spectroscopy: optical fiber probes for clinical applications	7
What is the feasibility of a clinical-scale and anticoagulation-free artificial placenta device?	7
Advancing clinical understanding of surface electromyography biofeedback: bridging research, teaching, and commercial applications	7
Multicenter randomized trial of carpal tunnel release with ultrasound guidance versus mini-open technique	7
Sacral neuromodulation for the treatment of overactive bladder: systematic review and future prospects	7
Techniques in hybrid repair of aortic arch and thoracoabdominal aortic pathologies	7
Therapeutic biliary stents: applications and opportunities	7
Right heart failure after durable left ventricular assist device implantation	7
Technological solution for the assessment and rehabilitation of visuo-cognition in Parkinson’s disease	7
Device profile of the EVOQUE Eos system for transcatheter mitral valve replacement: a brief narrative review	7
Device evaluation: eCoin #x2013; implantable tibial nerve stimulator for overactive bladder	7
Evaluation of validity and reliability of novel rapid measurement for infundibulopelvic angle: a comparison with PACS system	7
Teleophthalmology-enabled devices: bridging the gap in rural eye care	7
Pulsed field ablation for atrial fibrillation	6
Hearables, in-ear sensing devices for bio-signal acquisition: a narrative review	6
Devices for osteoarthritis symptoms treatment: a patent review	6
The frozen elephant trunk: an overview of hybrid prostheses	6
Therapeutic prostate cancer interventions: a systematic review on pubic arch interference and needle positioning errors	6
Resilient design: decentralized trials recovered faster from the impact of COVID-19 than traditional site-based designs	6
Long axial field-of-view PET/CT devices: are we ready for the technological revolution?	6
The role of feedback in the robotic-assisted upper limb rehabilitation in people with multiple sclerosis: a systematic review	6
Legal and regulatory challenges in multi-country data-driven projects developing and validating medical AI systems in the EU	6
Digital colposcopy image analysis techniques requirements and their role in clinical diagnosis: a systematic review	6
Bone biopsy devices - a patent review	6
Mixed reality in interventional radiology: a focus on first clinical use of XR90 augmented reality-based visualization and navigation platform	6
Modular cardiac rhythm management system and results of MODULAR ATP trial: an era of personalized device medicine	6
Limited value of current shoulder arthroplasty registries in evidence-based shoulder surgery: a review of 7 national registries	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	5
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	5
Transcutaneous electric nerve stimulation in restless leg syndrome with cirrhosis: a pilot study	5
Addendum	5
Meta-analysis of clinical outcomes in cardiac resynchronisation therapy: his bundle pacing vs biventricular pacing	5
Development and verification of a novel bone collector with automatic size separating function for orthopedics surgery	5
Bridging the gap in the symptomatic heart failure patient journey: insights from the Italian scenario	5
Compatibility and durability of the gel stent material	5
A review: artificial intelligence in image-guided spinal surgery	5
Value of colposcopy with dynamic spectral imaging in the detection and evolution of high-grade cervical lesions	5
Use of the PRECICE nail for distraction osteogenesis after tumor resection	5
Current development and clinical applications of artificial anal sphincter	5
Tests for the identification of reflex syncope mechanism	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
When is a wearable defibrillator indicated?	5
Breaking the ice through an effective translationality in neurorehabilitation: are we heading to the right direction?	5
Relative utility of portable ECG devices in capturing arrhythmias in athletes	5
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	5
Comparison of mid-term survival of uncemented total knee arthroplasties with modular tibial components made of porous tantalum vs. cemented total knee arthroplasties	5
Smart clothing for human movement analysis: future application in sport and clinical practice	5
Endovascular reconstruction of the aortic arch with new-generation dual-branch and triple-branch endograft: design, applicability, indications, outcomes, and future directions	5
Selection criteria in the era of perfect competition for drug-eluting stents - a survey of interventional cardiologists in Japan: the selection-DES study	5
Endocardial versus epicardial pacing in pacemaker-dependent patients after device extraction: a meta-analysis	5
A systematic review of follow-up results of additively manufactured customized implants for the pelvic area	4
Software as Medical Devices: requirements and regulatory landscape in the United States	4
Is there a role for continuous glucose monitoring beyond diabetes? Emerging applications in new populations	4
Feasibility and patient’s experiences of perioperative telemonitoring in major abdominal surgery: an observational pilot study	4
Review of mechanisms of expandable spine surgery devices	4
An update on the evidence for and against the use of intraocular lenses in infants and young children	4
Anterior Segment Optical Coherence Tomography in Pediatric Ocular Pathology: Imaging Study of 115 eyes	4
Emerging technologies for combating pandemics	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
Letter to the editor on ‘the potential power of neuralink – how brain-machine interfaces can revolutionize medicine’	4
Anatomic feasibility of a novel modular triple-branched endograft for patients with aortic arch pathologies	4
Assessing flow diverter porosity: a comparative analysis of quantification techniques based on imaging and simulation	4
Device profile of the iTind temporary implantable nitinol device for benign prostatic hyperplasia	4
Assessment of microcirculatory alteration by a vascular occlusion test using near-infrared spectroscopy in pediatric cardiac surgery: effect of cardiopulmonary bypass	4
Preparing for the new wave of intrathecal CNS therapies: innovations in drug delivery devices	4
Ventricular tachycardia ablation as an alternative to implantable cardioverter-defibrillators in patients with preserved ejection fraction: current status and future prospects	4
Resource utilization and costs for robotic-assisted and manual total knee arthroplasty – a premier healthcare database study	4
Patient-specific instrumentation makes sense in total knee arthroplasty	4
Prevention of prosthetic joint infection/surgical site infection: what did the International Consensus Meeting decide?	4
Visual performance during night driving after intraocular refractive surgery procedures	4
Vascular access closure devices in neurointerventional procedures: current developments and future directions	4
Rehabilitation robotics after stroke: a bibliometric literature review	4
A comparative study of medical device regulation between countries based on their economies	4
The current use of tissue expanders in breast reconstruction: device design, features, and technical considerations	4

Diagnostic value of 24-hour Holter monitoring and conventional electrocardiogram in arrhythmia	4
Robotic navigation during spine surgery: an update of literature	4
Intragastric balloons for obesity: critical review of device design, efficacy, tolerability, and unmet clinical needs	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
Comparison of various video laryngoscopes for nasotracheal intubation in simulated difficult airway scenarios: a randomized self-controlled crossover trial	4
Efficacy of LMA gastro airway versus endotracheal tube for therapeutic endoscopic retrograde cholangiopancreatography under general anesthesia: a randomized trial	3
Uniportal versus biportal endoscopic spine surgery: a comprehensive review	3
Test-retest reliability of pain extent and pain location using a novel pain drawing analysis software application, on patients with shoulder pain	3
Current and future directions for the use of handheld fundus cameras in telehealth	3
Future potential of responsive neurostimulation for the treatment of Lennox-Gastaut syndrome	3
Histological examination of tooth-derived biomaterials obtained from different devices	3
The CardioMEMS Heart Failure System for chronic heart failure – a European perspective	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
Appropriate use criteria of left atrial appendage closure devices: latest evidences	3
Minimally invasive capillary blood sampling methods	3
A review of arrhythmia detection based on electrocardiogram with artificial intelligence	3
Emergency provider preference for powered intraosseous devices and satisfaction with features improving safety, reliability, and ease-of-use	3
Focused ultrasound: focused on tremor	3
Deep brain stimulation for Alzheimer’s disease – current status and next steps	3
A retrospective study of reported adverse events associated with cardiac stents in Indian population	3
Evaluations of medical device usability during clinical investigations: a scoping review of clinical study protocols	3
GI genius endoscopy module: a clinical profile	3
Treatment of brief episodes of highly symptomatic supraventricular and ventricular arrhythmias: a methodological review	3
Outcomes and evaluation of endoscopic retrograde cholangiopancreatography via Gastro-Laryngeal Tube in adult patients: a prospective randomised control study	3
American and European legislation on border medical devices	3
Effectiveness and safety of implantable loop recorder and clinical utility of remote monitoring in patients with unexplained, recurrent, traumatic syncope	3
Updates in immunocompatibility of biomaterials: applications for regenerative medicine	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
Low profile endografts for the endovascular treatment of abdominal aortic aneurysms	3
The evolving role of real-world evidence in medical device approvals in the United States	3
Indications and outcomes of revision total ankle arthroplasty	3
Is conduction system pacing a panacea for pacemaker therapy?	3
Comparison of 6-lead smartphone ECG and 12-lead ECG in athletes and a genetic heart disease population	3
Atrial flow regulators for the treatment of pulmonary arterial hypertension: what does the future hold?	3
Determinants of return to activity and work after carpal tunnel release: a systematic review and meta-analysis	3
S-ICDs: advantages and opportunities for improvement	3
Hydrophilic biomaterial intravenous hydrogel catheter for complication reduction in PICC and midline catheters	3
Prognostic value of renal failure in patients undergoing transvenous lead extraction: single centre experience and systematic review of the literature	3
Response to comment on ‘Comparative validation of handheld fractional exhaled nitric oxide measurements’	3
Development of theranostic wound dressings: harnessing the knowledge of biospecific interactions at the biomaterial interface to promote healing and identify biomarkers	3
From plugging air leaks to reducing lung volume: a review of the many uses of endobronchial valves	3
Magnetic resonance-guided ultrasound thalamotomy for essential tremor: a review	3
Usefulness of insertable cardiac monitors for risk stratification: current indications and clinical evidence	3
Ablate and pace strategy for atrial fibrillation: pacing modalities, ablation approaches and impact on patient outcomes	3
99m Tc-labeled and functionalised plasmonic nanoparticles for photo-thermal therapy of primary tumours	3
Hospital medical device quality and safety monitoring using real-world data from Friuli Venezia Giulia regional health coordination agency	3
The added value of lung perfusion scintigraphy semiquantitative measures in post-COVID patients with persistent dyspnea without pulmonary embolism	2
Wearable technology in inflammatory bowel disease: current state and future direction	2
Comment on ‘comparative validation of handheld fractional exhaled nitric oxide measurements’	2
EVO/EVO+ Visian Implantable Collamer Lenses for the correction of myopia and myopia with astigmatism	2
Advances in deep brain stimulation for the treatment of post-traumatic stress disorder	2
Profile of the Respimat soft mist inhaler for chronic obstructive pulmonary disease treatment: overview of its safety and efficacy	2
Diagnostic accuracy of liver stiffness on two-dimensional shear wave elastography for detecting clinically significant portal hypertension: a meta-analysis	2
Response to letter to the editor: “Two-year outcomes using fast-acting sub-perception therapy for spinal cord stimulation: results of a real-world multicenter study in the United States”	2
Current status and prospects of robot-assisted spine surgery	2
Continuous monitoring of vital signs with the Everion biosensor on the surgical ward: a clinical validation study	2
Transcranial direct current stimulation combined with peripheral stimulation in chronic pain: a systematic review and meta-analysis	2
The E-nside, multi-inner branch-based off-the-shelf stent graft for the treatment of thoracoabdominal aortic aneurysms	2
Medical device shelf-life and recalls: navigating healthcare challenges	2
Safety and effectiveness of left atrial appendage closure in patients with non-valvular atrial fibrillation and prior major bleeding	2
Clinical trial design in FDA submissions for neuromodulation devices, 1960–2023: a systematic review and meta-analysis	2
The modern pharmacological approach to diabetes: innovative methods of monitoring and insulin treatment	2
Interaction between maintenance variables of medical ultrasound scanners through multifactor dimensionality reduction	2
Comparative analysis of measurements of the anterior segment and the axial length parameters of the eyeball obtained with optical and ultrasound technique	2
Integration of artificial intelligence into cardiac ultrasonography practice	2
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	2
Vigilance and medical devices: from theory to the field, the example of electroporation in atrial fibrillation	2
Analysis of clinical outcomes and prognosis of patients with early bronchogenic lung cancer after treatment of rigid bronchoscopy combining fiberoptic bronchoscopy: a single-center retrospective study	2
Which way forward? Comparing radiological outcomes using three different surgical approaches in robotic assisted total hip arthroplasty	2
Technology, pharmacology, and clinical outcomes of sirolimus coated balloons for peripheral arterial interventions	2
Diaphragm neurostimulation in mechanical ventilation: current status and future prospects	2
Closed-loop systems for deep brain stimulation to treat neuropsychiatric disorders	2
Biomaterial engineering surface to control polymicrobial dental implant-related infections: focusing on disease modulating factors and coatings development	2
Bimodular femoral stems in primary total hip arthroplasty	2
Sex differences in 123I-mIBG scintigraphy imaging techniques in patients with heart failure	2
Ceramic-based 3D printed bone graft in bone tissue reconstruction: a systematic review and proportional meta-analysis of clinical studies	2
Design, evolution, and experience with the candy plug device for endovascular false lumen occlusion of chronic aortic dissections	2
Emerging transcatheter heart valve technologies for severe aortic stenosis	2
Regulation, approval, and access of spinal implants in low-middle-income countries: a narrative review and case study	2
Immune responses to implants: how can they be anticipated and managed?	2
Vascular changes in optical coherence tomography angiography unveiling the depths of dry age-related macular degeneration: a review	2
Printing hearts: three-dimensional printing as a transformative technology in transcatheter mitral valve interventions	2
Haemodynamic support with percutaneous devices in patients with cardiogenic shock: the current evidence of mechanical circulatory support	2
Prevention and repair of orthodontically induced root resorption using ultrasound: a scoping review	2
Foreword: aortic surgical devices: innovation, trends & controversies	2
Comparison and convergence of compartment syndrome techniques: a narrative review	2
A new approach to non-mydriatic portable fundus imaging	2
How robotic platforms are revolutionizing colorectal surgery techniques: a comparative review	2
Durable left ventricular assist devices as a bridge to transplantation: what to expect along the way?	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
Future perspectives and challenges of artificial intelligence implementation in remote monitoring of cardiac implantable electronic devices	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
Evaluating the effectiveness and safety of a remote electrical neuromodulation wearable device in treating chronic and episodic migraine: a retrospective, observational real-world evidence from India	2