Expert Review of Medical Devices

Article	Citations
The Incraft stent graft for the treatment of abdominal aortic aneurysms: an iliac-friendly device with an effective conventional proximal sealing mechanism	239
The use of predetermined change control plans to enable the release of new versions of software as a medical device	82
Cataract surgery: historical devices, modern innovations, and future perspectives	60
Axial length measurement failure rates using optical biometry based on swept-source OCT in cataractous eyes	40
Insertional effect following deep brain stimulation electrode implants	38
Penile compression devices for the treatment of urinary incontinence: current status and future prospects	37
Ambient assisted living systems for falls monitoring at home	35
COVID-19 lessons learned: medical devices at the core of global healthcare. A foreword on new challenges for expert review of medical devices!	35
Design of lower limb prosthetic sockets: a review	35
Ankle sprain bracing solutions and future design consideration for civilian and military use	33
Deep brain stimulation programming strategies: segmented leads, independent current sources, and future technology	29
Consumer-facing and professional medical devices in cardiology: monitoring and evaluation of big data and the implications for the practice of cardiology	29
The current status of breakthrough devices designation in the United States and innovative medical devices designation in Korea for digital health software	29
RETRACTED ARTICLE: Anatomy of a Woebot® (WB001): agent guided CBT for women with postpartum depression	28
Single-pulse transcranial magnetic stimulation for assessment of motor development in infants with early brain injury	26
Digital healthcare technologies: Modern tools to transform prosthetic care	25
Advances in additive manufacturing processes and their use for the fabrication of lower limb prosthetic devices	24
Peritoneal dialysis catheter design and function and implications for the clinical setting	23
Artificial pancreas systems: experiences from concept to commercialisation	23
Advantages of three-photon live imaging for deep tissue analysis	23
Redo aortic root – complexity vs simplicity with choice of device selected	22
The ‘Japanese paradox’ of total hip arthroplasty: where are we going?	21
A profile on the WISE cortical strip for intraoperative neurophysiological monitoring	21
Frozen elephant use in type a dissection: fundamentals, innovations, and pitfalls	19
Ultra high-frequency ultrasound in lymphatic surgery: the next frontier	18

Device profile of the FlareHawk interbody fusion system, an endplate-conforming multi-planar expandable lumbar interbody fusion cage	18
Economic evaluation of automated external defibrillator deployment in public settings for out-of-hospital cardiac arrest: a systematic review	18
Clinical benefit of transcutaneous afferent patterned stimulation (TAPS) in essential tremor patients with high unmet need: a secondary analysis of TAPS studies	18
Peregrine system infusion catheter for neurolytic renal denervation in hypertension: an overview of its safety and efficacy	17
A review of transcranial pulse stimulation: innovations in neuromodulation	17
Clinician satisfaction and preference for central venous catheter systems promoting patient safety, ease-of-use and reduced clinician error	17
Digital therapeutics as a new weapon against diseases: focus on the current European legislation and possible therapeutic strategies	16
Toward applying a device to reduce motion artifact during imaging: a randomized controlled trial	15
Percutaneous auricular neuromodulation for postoperative analgesia	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
Electromagnetic interference from automobile passive keyless entry in cardiovascular implantable electronic devices	14
Robotic assistance in total knee arthroplasty surgery: necessity or trend?	13
An update on locoregional percutaneous treatment technologies in colorectal cancer liver metastatic disease	13
A software-based lung function assessment tool: an interview with VoiceMed	13
The Ovation Alto platform: extending endovascular treatment beyond short-necked abdominal aortic aneurysms	13
Device profile of the eversense continuous glucose monitoring system for glycemic control in type-1 diabetes: overview of its safety and efficacy	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
The potential power of Neuralink – how brain-machine interfaces can revolutionize medicine	12
Device profile of the Mobi-C artificial cervical disc: an overview of its safety and efficacy	12
MetaHealth: unlocking metaverse technologies in digital healthcare	12
A randomized crossover comparison of the bébé VieScope and direct laryngoscope for pediatric airway management by nurses in medical simulation settings	12
Optimizing the clinical adoption of total joint replacement of the lumbar spine through imaging, robotics and artificial intelligence	12
Remote monitoring of implantable electronic devices to predict heart failure decompensation	11
Device profile of the Orchid safety release valve for the prevention of accidental catheter dislodgement	11
Transforming medical education: the impact of innovations in technology and medical devices	11
Virtual reality therapy combined with physiological monitoring provides effective treatment, with objective metrics, for post-traumatic stress disorder	11
Dynamic versus standard bougies for tracheal intubation with direct or indirect laryngoscopy in simulated or real scenarios: a systematic review and meta-analysis	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
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
Correction	10
Radiofrequency spectroscopy with intraoperative pathological assessment for breast carcinoma: synergistic or redundant?	10
Wearable electroencephalography for ultra-long-term seizure monitoring: a systematic review and future prospects	10
Effectiveness of mental health chatbots in depression and anxiety for adolescents and young adults: a meta-analysis of randomized controlled trials	10
Proactive esophageal cooling during radiofrequency cardiac ablation: data update including applications in very high-power short duration ablation	10
Digital health; what do we mean by clinical validation?	10
Utilization of preoperative EOS imaging to prevent adverse events following total hip arthroplasty	10
Revolutionizing breast cancer care: the synergy of AI-powered diagnostics, haptic-based biopsy simulators, and advanced surgical techniques	10
Differentiating between hepatocellular carcinoma and its mimickers using contrast-enhanced ultrasound with perflubutane microbubbles	10
Can digital health help improve medication adherence in cardiovascular disease?	9
Artificially intelligent chatbots in digital mental health interventions: a review	9
Tumor treating fields for glioblastoma: opportunities and drawbacks	9
A pilot study of optical coherence tomography-guided transbronchial biopsy in peripheral pulmonary lesions	9
The transvaginal mesh: an overview of indications and contraindications for its use	9
Sacral neuromodulation for the treatment of overactive bladder: systematic review and future prospects	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
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
Multicenter randomized trial of carpal tunnel release with ultrasound guidance versus mini-open technique	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’	8

Profile of the Ovation ALTO abdominal stent graft for the treatment of abdominal aortic aneurysms: overview of its safety and efficacy	8
Technological solution for the assessment and rehabilitation of visuo-cognition in Parkinson’s disease	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
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
Paired associative stimulation to enhance motor outcome in spinal cord injury: a systematic review of first evidence	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	7
Mixed reality in interventional radiology: a focus on first clinical use of XR90 augmented reality-based visualization and navigation platform	7
In vivo spectroscopy: optical fiber probes for clinical applications	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
Therapeutic biliary stents: applications and opportunities	7
The role of feedback in the robotic-assisted upper limb rehabilitation in people with multiple sclerosis: a systematic review	7
Evaluation of validity and reliability of novel rapid measurement for infundibulopelvic angle: a comparison with PACS system	6
Digital colposcopy image analysis techniques requirements and their role in clinical diagnosis: a systematic review	6
Compatibility and durability of the gel stent material	6
Transperineal prostate biopsy using the PrecisionPoint Transperineal Access System for prostate cancer diagnosis – a new standard of care	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
Pulsed field ablation for atrial fibrillation	6
Advancing clinical understanding of surface electromyography biofeedback: bridging research, teaching, and commercial applications	6
Long axial field-of-view PET/CT devices: are we ready for the technological revolution?	6
Bridging the gap in the symptomatic heart failure patient journey: insights from the Italian scenario	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
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
Bone biopsy devices - a patent review	6
Right heart failure after durable left ventricular assist device implantation	6
Devices for osteoarthritis symptoms treatment: a patent review	6
When is a wearable defibrillator indicated?	6
Breaking the ice through an effective translationality in neurorehabilitation: are we heading to the right direction?	6
Modular cardiac rhythm management system and results of MODULAR ATP trial: an era of personalized device medicine	6
Hearables, in-ear sensing devices for bio-signal acquisition: a narrative review	6
Tests for the identification of reflex syncope mechanism	5
Endovascular reconstruction of the aortic arch with new-generation dual-branch and triple-branch endograft: design, applicability, indications, outcomes, and future directions	5
The frozen elephant trunk: an overview of hybrid prostheses	5
Addendum	5
Smart clothing for human movement analysis: future application in sport and clinical practice	5
Transcutaneous electric nerve stimulation in restless leg syndrome with cirrhosis: a pilot study	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
Advances in intravascular lithotripsy: mechanisms, devices, and clinical applications	5
Continuous glucose monitoring in persons with type 2 diabetes not using insulin	5
Current development and clinical applications of artificial anal sphincter	5
Meta-analysis of clinical outcomes in cardiac resynchronisation therapy: his bundle pacing vs biventricular pacing	5
Legal and regulatory challenges in multi-country data-driven projects developing and validating medical AI systems in the EU	5
Development and verification of a novel bone collector with automatic size separating function for orthopedics surgery	5
Limited value of current shoulder arthroplasty registries in evidence-based shoulder surgery: a review of 7 national registries	5
A review: artificial intelligence in image-guided spinal surgery	5
Relative utility of portable ECG devices in capturing arrhythmias in athletes	5
Use of the PRECICE nail for distraction osteogenesis after tumor resection	5
Device profile of the iTind temporary implantable nitinol device for benign prostatic hyperplasia	4
Emerging technologies for combating pandemics	4
Resource utilization and costs for robotic-assisted and manual total knee arthroplasty – a premier healthcare database study	4
Feasibility and patient’s experiences of perioperative telemonitoring in major abdominal surgery: an observational pilot study	4
Comparison of various video laryngoscopes for nasotracheal intubation in simulated difficult airway scenarios: a randomized self-controlled crossover trial	4
Value of colposcopy with dynamic spectral imaging in the detection and evolution of high-grade cervical lesions	4
Vascular access closure devices in neurointerventional procedures: current developments and future directions	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
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
Assessment of microcirculatory alteration by a vascular occlusion test using near-infrared spectroscopy in pediatric cardiac surgery: effect of cardiopulmonary bypass	4
A comparative study of medical device regulation between countries based on their economies	4
Patient-specific instrumentation makes sense in total knee arthroplasty	4
HOPE for a better selection of patients for cardiac contractility modulation	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
Letter to the editor on ‘the potential power of neuralink – how brain-machine interfaces can revolutionize medicine’	4
Rehabilitation robotics after stroke: a bibliometric literature review	4
Prevention of prosthetic joint infection/surgical site infection: what did the International Consensus Meeting decide?	4
Diagnostic value of 24-hour Holter monitoring and conventional electrocardiogram in arrhythmia	4
Review of mechanisms of expandable spine surgery devices	4
Ventricular tachycardia ablation as an alternative to implantable cardioverter-defibrillators in patients with preserved ejection fraction: current status and future prospects	4
Minimally invasive capillary blood sampling methods	4
Is open anterior advantageous to posterior decompression and reconstruction in fresh A 3 to C 3 /AO type thoracolumbar junction fr	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
A systematic review of follow-up results of additively manufactured customized implants for the pelvic area	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
Intragastric balloons for obesity: critical review of device design, efficacy, tolerability, and unmet clinical needs	4

Is there a role for continuous glucose monitoring beyond diabetes? Emerging applications in new populations	4
Updates in immunocompatibility of biomaterials: applications for regenerative medicine	3
Usefulness of insertable cardiac monitors for risk stratification: current indications and clinical evidence	3
Deep brain stimulation for Alzheimer’s disease – current status and next steps	3
Noninvasive vagus nerve stimulation in Parkinson’s disease: current status and future prospects	3
Atrial flow regulators for the treatment of pulmonary arterial hypertension: what does the future hold?	3
Appropriate use criteria of left atrial appendage closure devices: latest evidences	3
Histological examination of tooth-derived biomaterials obtained from different devices	3
Development of theranostic wound dressings: harnessing the knowledge of biospecific interactions at the biomaterial interface to promote healing and identify biomarkers	3
Efficacy of LMA gastro airway versus endotracheal tube for therapeutic endoscopic retrograde cholangiopancreatography under general anesthesia: a randomized trial	3
GI genius endoscopy module: a clinical profile	3
Evaluations of medical device usability during clinical investigations: a scoping review of clinical study protocols	3
Preparing for the new wave of intrathecal CNS therapies: innovations in drug delivery devices	3
Hospital medical device quality and safety monitoring using real-world data from Friuli Venezia Giulia regional health coordination agency	3
American and European legislation on border medical devices	3
Treatment of brief episodes of highly symptomatic supraventricular and ventricular arrhythmias: a methodological review	3
Focused ultrasound: focused on tremor	3
Response to comment on ‘Comparative validation of handheld fractional exhaled nitric oxide measurements’	3
Uniportal versus biportal endoscopic spine surgery: a comprehensive review	3
A review of arrhythmia detection based on electrocardiogram with artificial intelligence	3
A retrospective study of reported adverse events associated with cardiac stents in Indian population	3
99m Tc-labeled and functionalised plasmonic nanoparticles for photo-thermal therapy of primary tumours	3
Ablate and pace strategy for atrial fibrillation: pacing modalities, ablation approaches and impact on patient outcomes	3
Current and future directions for the use of handheld fundus cameras in telehealth	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
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 CardioMEMS Heart Failure System for chronic heart failure – a European perspective	3
Robotic navigation during spine surgery: an update of literature	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
Magnetic resonance-guided ultrasound thalamotomy for essential tremor: a review	3
Indications and outcomes of revision total ankle arthroplasty	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
From plugging air leaks to reducing lung volume: a review of the many uses of endobronchial valves	3
Comparison of 6-lead smartphone ECG and 12-lead ECG in athletes and a genetic heart disease population	3
Emergency provider preference for powered intraosseous devices and satisfaction with features improving safety, reliability, and ease-of-use	3
The evolving role of real-world evidence in medical device approvals in the United States	3
Outcomes and evaluation of endoscopic retrograde cholangiopancreatography via Gastro-Laryngeal Tube in adult patients: a prospective randomised control study	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
Is conduction system pacing a panacea for pacemaker therapy?	3
Effectiveness and safety of implantable loop recorder and clinical utility of remote monitoring in patients with unexplained, recurrent, traumatic syncope	3
Test-retest reliability of pain extent and pain location using a novel pain drawing analysis software application, on patients with shoulder pain	3
Comparison and convergence of compartment syndrome techniques: a narrative review	2
Comparison of clinical efficacy of three different dentin matrix biomaterials obtained from different devices	2
Ceramic-based 3D printed bone graft in bone tissue reconstruction: a systematic review and proportional meta-analysis of clinical studies	2
The added value of lung perfusion scintigraphy semiquantitative measures in post-COVID patients with persistent dyspnea without pulmonary embolism	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
Biomaterial engineering surface to control polymicrobial dental implant-related infections: focusing on disease modulating factors and coatings development	2
Safety and effectiveness of left atrial appendage closure in patients with non-valvular atrial fibrillation and prior major bleeding	2
Sex differences in 123I-mIBG scintigraphy imaging techniques in patients with heart failure	2
Regulation, approval, and access of spinal implants in low-middle-income countries: a narrative review and case study	2
Continuous monitoring of vital signs with the Everion biosensor on the surgical ward: a clinical validation study	2
The E-nside, multi-inner branch-based off-the-shelf stent graft for the treatment of thoracoabdominal aortic aneurysms	2
Device profile of EndoAnchors for aortic stent graft implantation: overview of their safety and efficacy	2
Wearable technology in inflammatory bowel disease: current state and future direction	2
Emerging transcatheter heart valve technologies for severe aortic stenosis	2
Interaction between maintenance variables of medical ultrasound scanners through multifactor dimensionality reduction	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
Comparison of the supraglottic airway device BlockBusterTM and laryngeal mask airway Supreme in anaesthetised, paralyzed adult patients: a multicenter randomized controlled trial	2
Chronic electroencephalography in epilepsy with a responsive neurostimulation device: current status and future prospects	2
Critical analysis of in vitro stability testing of spinal implants and proposal for standardization	2
The modern pharmacological approach to diabetes: innovative methods of monitoring and insulin treatment	2
Design trends in actuated lower-limb prosthetic systems: a narrative review	2
Is there a best choice of equipment for colorectal endoscopic submucosal dissection?	2
Immune responses to implants: how can they be anticipated and managed?	2
Durable left ventricular assist devices as a bridge to transplantation: what to expect along the way?	2
Design, evolution, and experience with the candy plug device for endovascular false lumen occlusion of chronic aortic dissections	2
Hydrus microstent for the treatment of primary open-angle glaucoma: overview of its safety and efficacy	2
Clinical profile of the SEM Scanner — Modernizing pressure injury care pathways using Sub-Epidermal Moisture (SEM) scanning	2
A profile on the CardioMEMS HF system in the management of patients with early stages of heart failure: an update	2
Diaphragm neurostimulation in mechanical ventilation: current status and future prospects	2
Navigating hypotony challenges with XEN gel implantation	2
Readmission rate and healthcare utilization outcomes of computer-assisted fluoroscopy-based hip navigation versus manual total hip arthroplasty	2
Recent advances in the use of ultrasound in Crohn’s disease	2
A novel design of low-cost hearing aid devices using an efficient lifting filter bank with a modified variable filter	2
Transcranial direct current stimulation combined with peripheral stimulation in chronic pain: a systematic review and meta-analysis	2
Comment on ‘comparative validation of handheld fractional exhaled nitric oxide measurements’	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
Wearable inertial sensors for human movement analysis: a five-year update	2
Current status and prospects of robot-assisted spine surgery	2
Future perspectives and challenges of artificial intelligence implementation in remote monitoring of cardiac implantable electronic devices	2
A new approach to non-mydriatic portable fundus imaging	2
Antithrombotic therapy after transcatheter aortic valve implantation	2
Bimodular femoral stems in primary total hip arthroplasty	2
Comparative study of biomodels manufactured using 3D printing techniques for surgical planning and medical training	2
Closed-loop systems for deep brain stimulation to treat neuropsychiatric disorders	2
Platinum chromium everolimus-eluting stents for the treatment of (complex) coronary artery disease; from SYNERGY™ to the MEGATRON™	1
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
Advantages and limitations of mobile-bearing unicompartmental knee arthroplasty: an overview of the literature	1
Letter to the editor in response to: A profile on the WISE cortical strip for intraoperative neurophysiological monitoring	1
Functional electrical stimulation as a tool to restore motor control after spinal cord injury: translation to clinical practice	1