Expert Review of Medical Devices

Article	Citations
Consumer-facing and professional medical devices in cardiology: monitoring and evaluation of big data and the implications for the practice of cardiology	76
COVID-19 lessons learned: medical devices at the core of global healthcare. A foreword on new challenges for expert review of medical devices!	63
Axial length measurement failure rates using optical biometry based on swept-source OCT in cataractous eyes	44
Penile compression devices for the treatment of urinary incontinence: current status and future prospects	43
Ambient assisted living systems for falls monitoring at home	39
Insertional effect following deep brain stimulation electrode implants	38
Advances in additive manufacturing processes and their use for the fabrication of lower limb prosthetic devices	33
Single-pulse transcranial magnetic stimulation for assessment of motor development in infants with early brain injury	29
Cataract surgery: historical devices, modern innovations, and future perspectives	28
Totally implanted ports and peripherally inserted central catheters for chemotherapy: a systematic review and meta-analysis of clinical outcomes and economic evaluations	26
Point-of-care ultrasound in cardiovascular imaging: current status and future prospects	25
Peri-procedural vs. post-procedural mortality after endobronchial valve treatment for severe emphysema: a systematic review and meta-analysis of randomized controlled trials	25
Advantages of three-photon live imaging for deep tissue analysis	24
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
Optimizing atrial fibrillation detection: a review of subcutaneous cardiac rhythm monitors and consumer technologies	22
Clinician satisfaction and preference for central venous catheter systems promoting patient safety, ease-of-use and reduced clinician error	22
The ‘Japanese paradox’ of total hip arthroplasty: where are we going?	21
A review of transcranial pulse stimulation: innovations in neuromodulation	19
Artificial pancreas systems: experiences from concept to commercialisation	18
A profile on the WISE cortical strip for intraoperative neurophysiological monitoring	17
Promising next generation left ventricular assist devices: prospects for best treatment opportunities for patients with heart failure	17
Economic evaluation of automated external defibrillator deployment in public settings for out-of-hospital cardiac arrest: a systematic review	17
Ultra high-frequency ultrasound in lymphatic surgery: the next frontier	16
Frozen elephant use in type a dissection: fundamentals, innovations, and pitfalls	16

Device profile of the FlareHawk interbody fusion system, an endplate-conforming multi-planar expandable lumbar interbody fusion cage	15
A software-based lung function assessment tool: an interview with VoiceMed	15
Electromagnetic interference from automobile passive keyless entry in cardiovascular implantable electronic devices	15
Clinical benefit of transcutaneous afferent patterned stimulation (TAPS) in essential tremor patients with high unmet need: a secondary analysis of TAPS studies	15
The potential power of Neuralink – how brain-machine interfaces can revolutionize medicine	15
Redo aortic root – complexity vs simplicity with choice of device selected	15
Peregrine system infusion catheter for neurolytic renal denervation in hypertension: an overview of its safety and efficacy	15
Robotic assistance in total knee arthroplasty surgery: necessity or trend?	15
Complications after peripherally inserted central catheter versus central venous catheter implantation in intensive care unit: propensity score analysis using a nationwide database	14
Digital therapeutics as a new weapon against diseases: focus on the current European legislation and possible therapeutic strategies	14
Optimizing the clinical adoption of total joint replacement of the lumbar spine through imaging, robotics and artificial intelligence	14
Percutaneous auricular neuromodulation for postoperative analgesia	13
A randomized crossover comparison of the bébé VieScope and direct laryngoscope for pediatric airway management by nurses in medical simulation settings	13
An update on locoregional percutaneous treatment technologies in colorectal cancer liver metastatic disease	13
Implantable medical devices for tendon and ligament repair: a review of patents and commercial products	13
MetaHealth: unlocking metaverse technologies in digital healthcare	13
A review on the impact of cardiac pacing on right ventricular and tricuspid valve function	12
Telemedicine for hypertension management: a paradigm shift from telemonitoring to digital therapeutics	12
Transforming medical education: the impact of innovations in technology and medical devices	12
Device profile of the Mobi-C artificial cervical disc: an overview of its safety and efficacy	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
Device profile of the Orchid safety release valve for the prevention of accidental catheter dislodgement	11
Differentiating between hepatocellular carcinoma and its mimickers using contrast-enhanced ultrasound with perflubutane microbubbles	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
Revolutionizing breast cancer care: the synergy of AI-powered diagnostics, haptic-based biopsy simulators, and advanced surgical techniques	11
Virtual reality therapy combined with physiological monitoring provides effective treatment, with objective metrics, for post-traumatic stress disorder	10
Can digital health help improve medication adherence in cardiovascular disease?	10
Tumor treating fields for glioblastoma: opportunities and drawbacks	10
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	10
Efficacy of targeted neuromodulation treatments: a clinical report	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
Correction	10
Restriction of PFAS use in medical devices – what next for medical device manufacturers?	10
Utilization of preoperative EOS imaging to prevent adverse events following total hip arthroplasty	10
A pilot study of optical coherence tomography-guided transbronchial biopsy in peripheral pulmonary lesions	10
Advances in minimally traumatic retinal laser therapy	9
Comparison of laryngeal exposure in bed-up-head-elevated Macintosh laryngoscopy vs. supine C-MAC video laryngoscopy: a randomized non-inferiority trial	9
Technological solution for the assessment and rehabilitation of visuo-cognition in Parkinson’s disease	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
Optical and video stylets for airway management: an expert review	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
What is the feasibility of a clinical-scale and anticoagulation-free artificial placenta device?	9
Proactive esophageal cooling during radiofrequency cardiac ablation: data update including applications in very high-power short duration ablation	9
The transvaginal mesh: an overview of indications and contraindications for its use	9
Teleophthalmology-enabled devices: bridging the gap in rural eye care	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
Effectiveness of mental health chatbots in depression and anxiety for adolescents and young adults: a meta-analysis of randomized controlled trials	9
Paired associative stimulation to enhance motor outcome in spinal cord injury: a systematic review of first evidence	8
Cardiac imaging for the detection of ischemia: current status and future perspectives	8
In vivo spectroscopy: optical fiber probes for clinical applications	8

Bone biopsy devices - a patent review	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
Altius Direct Electrical Nerve Stimulation for the treatment of lower extremity post-amputation pain: a device and literature review	8
From mixed signals to neural code: compensating volume conduction for noninvasive generic neural interfaces	8
The evolution of endoscopic ultrasound in Saudi Arabia: an expert review of clinical practice and literature	8
Device profile of the EVOQUE Eos system for transcatheter mitral valve replacement: a brief narrative review	8
Multicenter randomized trial of carpal tunnel release with ultrasound guidance versus mini-open technique	8
Evaluation of validity and reliability of novel rapid measurement for infundibulopelvic angle: a comparison with PACS system	8
Accuracy of thoracolumbar pedicle screw placement using intraoperative CT navigation versus 3D-printed patient-specific guides integrated with virtual surgical planning: a comparative study	8
Device evaluation: eCoin #x2013; implantable tibial nerve stimulator for overactive bladder	7
The role of feedback in the robotic-assisted upper limb rehabilitation in people with multiple sclerosis: a systematic review	7
Insights from expert panels on the EU clinical evaluation consultation procedure	7
Devices for osteoarthritis symptoms treatment: a patent review	7
Association of postoperative acetabular abduction angle with gait asymmetry and adverse reactions following total hip arthroplasty across different surgical approaches	7
Two sides to every wrist: trans-ulnar access for cardiac interventions	7
Therapeutic biliary stents: applications and opportunities	7
Advancing clinical understanding of surface electromyography biofeedback: bridging research, teaching, and commercial applications	7
The IlluminOss photodynamic bone stabilization system: novel technology with broad application in orthopaedic fracture fixation	7
Therapeutic prostate cancer interventions: a systematic review on pubic arch interference and needle positioning errors	7
Right heart failure after durable left ventricular assist device implantation	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
Modular cardiac rhythm management system and results of MODULAR ATP trial: an era of personalized device medicine	7
Transperineal prostate biopsy using the PrecisionPoint Transperineal Access System for prostate cancer diagnosis – a new standard of care	7
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	7
Pulsed field ablation for atrial fibrillation	7
Bridging the gap in the symptomatic heart failure patient journey: insights from the Italian scenario	6
Endovascular reconstruction of the aortic arch with new-generation dual-branch and triple-branch endograft: design, applicability, indications, outcomes, and future directions	6
Pulsed-field ablation: recent advancement in catheter ablation of atrial fibrillation	6
Efficacy of two anatomically preformed supraglottic devices, the BlockBuster Laryngeal mask airway and the Ambu AuraGain, for ventilation in anesthetised paralyzed pediatric patients: a randomized tri	6
A review: artificial intelligence in image-guided spinal surgery	6
Meta-analysis of clinical outcomes in cardiac resynchronisation therapy: his bundle pacing vs biventricular pacing	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
Advances in intravascular lithotripsy: mechanisms, devices, and clinical applications	6
Development and verification of a novel bone collector with automatic size separating function for orthopedics surgery	6
Tests for the identification of reflex syncope mechanism	6
Endocardial versus epicardial pacing in pacemaker-dependent patients after device extraction: a meta-analysis	6
Transcutaneous electric nerve stimulation in restless leg syndrome with cirrhosis: a pilot study	6
The frozen elephant trunk: an overview of hybrid prostheses	6
Legal and regulatory challenges in multi-country data-driven projects developing and validating medical AI systems in the EU	6
Impact of continuous positive airway pressure on the quality of life in patients with sleep apnea	6
Digital colposcopy image analysis techniques requirements and their role in clinical diagnosis: a systematic review	6
Addendum	6
Breaking the ice through an effective translationality in neurorehabilitation: are we heading to the right direction?	6
A systematic review of follow-up results of additively manufactured customized implants for the pelvic area	5
Prevention of prosthetic joint infection/surgical site infection: what did the International Consensus Meeting decide?	5
Anatomic feasibility of a novel modular triple-branched endograft for patients with aortic arch pathologies	5
Is open anterior advantageous to posterior decompression and reconstruction in fresh A 3 to C 3 /AO type thoracolumbar junction fr	5
Relative utility of portable ECG devices in capturing arrhythmias in athletes	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
Current development and clinical applications of artificial anal sphincter	5
Devices-based treatment of hypertension: the position of the European Society of Hypertension (ESH) 2023 guidelines	5
Review of regulatory requirements for benefit–risk assessment for medical devices: uncovering existing methodologies	5
Visual performance during night driving after intraocular refractive surgery procedures	5
Assessing flow diverter porosity: a comparative analysis of quantification techniques based on imaging and simulation	5
Resource utilization and costs for robotic-assisted and manual total knee arthroplasty – a premier healthcare database study	5
Anticipating stroke in patients undergoing transcatheter aortic valve replacement	5
Smaller defibrillation lead diameter is associated with less tricuspid regurgitation: a computational modeling study	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
Intragastric balloons for obesity: critical review of device design, efficacy, tolerability, and unmet clinical needs	5
Evaluation and management of coronary artery disease in transcatheter aortic valve implantation candidates with severe aortic stenosis and coronary artery disease: technology and techniques	5
Software as Medical Devices: requirements and regulatory landscape in the United States	5
Two-year outcomes using fast-acting sub-perception therapy for spinal cord stimulation: results of a real-world multicenter study in the United States	5
HOPE for a better selection of patients for cardiac contractility modulation	5
Hearing aids in low- and middle-income countries: from evidence to scale	5
Delivery assist catheters for mechanical thrombectomy: a systematic review	5
Comparison of various video laryngoscopes for nasotracheal intubation in simulated difficult airway scenarios: a randomized self-controlled crossover trial	5
Letter to the editor on ‘the potential power of neuralink – how brain-machine interfaces can revolutionize medicine’	5
Smart clothing for human movement analysis: future application in sport and clinical practice	5
Vascular access closure devices in neurointerventional procedures: current developments and future directions	5
Ethical concerns regarding a lack of standardized clinical demographic data: an audit of 2023 FDA medical devices	5
99m Tc-labeled and functionalised plasmonic nanoparticles for photo-thermal therapy of primary tumours	4
Usefulness of insertable cardiac monitors for risk stratification: current indications and clinical evidence	4
Evaluating regulatory oversight through major in vitro diagnostic recalls: a retrospective study of FDA data (2015–2024)	4
Uniportal versus biportal endoscopic spine surgery: a comprehensive review	4
GI genius endoscopy module: a clinical profile	4
Failure rates of meniscal repairs during anterior cruciate ligament reconstruction using different meniscal repair devices	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	4
Device profile of the iTind temporary implantable nitinol device for benign prostatic hyperplasia	4

Robotic navigation during spine surgery: an update of literature	4
Review of mechanisms of expandable spine surgery devices	4
Preparing for the new wave of intrathecal CNS therapies: innovations in drug delivery devices	4
Performance of a cementless medial collared, triple-tapered femoral stem used with the posterior approach in total hip arthroplasty: a comparative analysis using medicare data	4
The CardioMEMS Heart Failure System for chronic heart failure – a European perspective	4
Magnetic resonance-guided ultrasound thalamotomy for essential tremor: a review	4
Deep brain stimulation for Alzheimer’s disease – current status and next steps	4
The evolving role of real-world evidence in medical device approvals in the United States	4
Emergency provider preference for powered intraosseous devices and satisfaction with features improving safety, reliability, and ease-of-use	4
Effectiveness and safety of implantable loop recorder and clinical utility of remote monitoring in patients with unexplained, recurrent, traumatic syncope	4
Assessment of microcirculatory alteration by a vascular occlusion test using near-infrared spectroscopy in pediatric cardiac surgery: effect of cardiopulmonary bypass	4
The current use of tissue expanders in breast reconstruction: device design, features, and technical considerations	4
A comparative study of medical device regulation between countries based on their economies	4
Prognostic value of renal failure in patients undergoing transvenous lead extraction: single centre experience and systematic review of the literature	4
Current and future directions for the use of handheld fundus cameras in telehealth	4
Histological examination of tooth-derived biomaterials obtained from different devices	4
A retrospective study of reported adverse events associated with cardiac stents in Indian population	4
Comparison of 6-lead smartphone ECG and 12-lead ECG in athletes and a genetic heart disease population	4
Practical regulatory guidance for researchers manufacturing customized 3D (three-dimensional) – printed medical devices	4
Outcomes and evaluation of endoscopic retrograde cholangiopancreatography via Gastro-Laryngeal Tube in adult patients: a prospective randomised control study	4
Development of theranostic wound dressings: harnessing the knowledge of biospecific interactions at the biomaterial interface to promote healing and identify biomarkers	4
Anterior Segment Optical Coherence Tomography in Pediatric Ocular Pathology: Imaging Study of 115 eyes	4
Diagnostic value of 24-hour Holter monitoring and conventional electrocardiogram in arrhythmia	4
An update on the evidence for and against the use of intraocular lenses in infants and young children	4
Minimally invasive capillary blood sampling methods	4
Is there a role for continuous glucose monitoring beyond diabetes? Emerging applications in new populations	4
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	4
Focused ultrasound: focused on tremor	3
Advancing the future of prosthetic rehabilitation with Regenerative Peripheral Nerve Interface surgery: Questions and opportunities	3
The paradox between demanding evidence and seeking personal experience in the adoption of medical devices	3
Hydrus microstent for the treatment of primary open-angle glaucoma: overview of its safety and efficacy	3
Biomaterial engineering surface to control polymicrobial dental implant-related infections: focusing on disease modulating factors and coatings development	3
Comparison of clinical efficacy of three different dentin matrix biomaterials obtained from different devices	3
From plugging air leaks to reducing lung volume: a review of the many uses of endobronchial valves	3
Recent advances in the use of ultrasound in Crohn’s disease	3
Emerging transcatheter heart valve technologies for severe aortic stenosis	3
Authors’ reply to comments on ‘emerging monitoring techniques in oral appliance therapy for sleep apnea: a narrative review with a focus on mandibular jaw movement analysis’	3
Is there a best choice of equipment for colorectal endoscopic submucosal dissection?	3
Indications and outcomes of revision total ankle arthroplasty	3
Device profile of EndoAnchors for aortic stent graft implantation: overview of their safety and efficacy	3
Response to comment on ‘Comparative validation of handheld fractional exhaled nitric oxide measurements’	3
Test-retest reliability of pain extent and pain location using a novel pain drawing analysis software application, on patients with shoulder pain	3
Percutaneous left ventricular assist device in cardiogenic shock associated with and without acute myocardial infarction: a real-world retrospective cohort study	3
A post-market, randomized, controlled, prospective study evaluating intrathecal pain medication versus conventional medical management in the non-cancer, refractory, chronic pain population (PROSPER)	3
Comment on ‘comparative validation of handheld fractional exhaled nitric oxide measurements’	3
Is conduction system pacing a panacea for pacemaker therapy?	3
Readmission rate and healthcare utilization outcomes of computer-assisted fluoroscopy-based hip navigation versus manual total hip arthroplasty	3
Ceramic-based 3D printed bone graft in bone tissue reconstruction: a systematic review and proportional meta-analysis of clinical studies	3
The added value of lung perfusion scintigraphy semiquantitative measures in post-COVID patients with persistent dyspnea without pulmonary embolism	3
A comprehensive review of biliary cannulation techniques in endoscopic retrograde cholangiopancreatography	3
Design trends in actuated lower-limb prosthetic systems: a narrative review	3
Hospital medical device quality and safety monitoring using real-world data from Friuli Venezia Giulia regional health coordination agency	3
Comparison and convergence of compartment syndrome techniques: a narrative review	3
Mechanical force optimization for craniofacial distraction osteogenesis: current concepts and future direction — a comprehensive review of the literature	3
Ablate and pace strategy for atrial fibrillation: pacing modalities, ablation approaches and impact on patient outcomes	3
Navigating hypotony challenges with XEN gel implantation	3
American and European legislation on border medical devices	3
Current status and prospects of robot-assisted spine surgery	3
Appropriate use criteria of left atrial appendage closure devices: latest evidences	3
Low profile endografts for the endovascular treatment of abdominal aortic aneurysms	3
Future potential of responsive neurostimulation for the treatment of Lennox-Gastaut syndrome	3
Digital screening mammograms: current status and future prospects	3
Evaluations of medical device usability during clinical investigations: a scoping review of clinical study protocols	3
Immune responses to implants: how can they be anticipated and managed?	3
How robotic platforms are revolutionizing colorectal surgery techniques: a comparative review	3
Leadless and extracardiac cardiac rhythm management systems: the next generation of pacing and defibrillation	3
Current progress of active compliance control strategies and applications in lower limb exoskeleton rehabilitation robots: a narrative review	3
Global and regional prevalence, temporal trends, and projected trends of stroke after left ventricular assist device implantation: a systematic review and meta-analysis of 132,869 patients from 16 cou	3
Medical device shelf-life and recalls: navigating healthcare challenges	3
Effects of a single session of noninvasive auricular vagus nerve stimulation on sports performance in elite athletes: an open-label randomized controlled trial	3
Hydrophilic biomaterial intravenous hydrogel catheter for complication reduction in PICC and midline catheters	3
Sutureless versus transcatheter aortic valve replacement: propensity matched analysis	3
Diaphragm neurostimulation in mechanical ventilation: current status and future prospects	3
Efficacy of LMA gastro airway versus endotracheal tube for therapeutic endoscopic retrograde cholangiopancreatography under general anesthesia: a randomized trial	3
A profile on the CardioMEMS HF system in the management of patients with early stages of heart failure: an update	3
Assessment of alveolar capillary membrane permeability using technetium 99m-diethylene triamine pentaacetate (Tc99m–DTPA) aerosols in patients with diffuse cutaneous systemic sclerosis – a cross-secti	3
Comparative study of biomodels manufactured using 3D printing techniques for surgical planning and medical training	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
Sex differences in 123I-mIBG scintigraphy imaging techniques in patients with heart failure	3
Comparison of the supraglottic airway device BlockBusterTM and laryngeal mask airway Supreme in anaesthetised, paralyzed adult patients: a multicenter randomized controlled trial	3
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	3
A novel design of low-cost hearing aid devices using an efficient lifting filter bank with a modified variable filter	3
Vascular changes in optical coherence tomography angiography unveiling the depths of dry age-related macular degeneration: a review	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
Device profile of Optilume BPH Catheter System for minimally invasive treatment of benign prostatic hyperplasia	2
Securing the internet of medical things in remote patient monitoring and the hospital at home: an interview with Stephen Gilbert	2
A review of modeling and control of remote-controlled capsule endoscopes	2
Expert-involved continuous renal replacement therapy device development: addressing user needs through human factors engineering	2
Comparison of the HugeMed video laryngoscope with the Macintosh direct laryngoscope for nasotracheal tracheal intubation in children undergoing dental treatment: a randomized controlled clinical study	2
Post-operative infection with a single-use ureteroscope with real-time intrarenal pressure monitoring vs. all other single-use ureteroscopes	2
Prismatic treatment combined with binocular visual training for intermittent exotropia: impact on visual function and quality of life	2
Blood pressure response with obstructive sleep apnoea treatment: mandibular advancement device versus continuous positive airway pressure	2
Retrograde cerebral perfusion to support aortic arch repair	2
Integration of artificial intelligence into cardiac ultrasonography practice	2