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	65
COVID-19 lessons learned: medical devices at the core of global healthcare. A foreword on new challenges for expert review of medical devices!	53
Axial length measurement failure rates using optical biometry based on swept-source OCT in cataractous eyes	40
Penile compression devices for the treatment of urinary incontinence: current status and future prospects	39
Advantages of three-photon live imaging for deep tissue analysis	38
Ambient assisted living systems for falls monitoring at home	33
Insertional effect following deep brain stimulation electrode implants	33
Totally implanted ports and peripherally inserted central catheters for chemotherapy: a systematic review and meta-analysis of clinical outcomes and economic evaluations	30
Advances in additive manufacturing processes and their use for the fabrication of lower limb prosthetic devices	28
The use of predetermined change control plans to enable the release of new versions of software as a medical device	26
Cataract surgery: historical devices, modern innovations, and future perspectives	25
Single-pulse transcranial magnetic stimulation for assessment of motor development in infants with early brain injury	24
Frozen elephant use in type a dissection: fundamentals, innovations, and pitfalls	23
Peritoneal dialysis catheter design and function and implications for the clinical setting	23
Clinician satisfaction and preference for central venous catheter systems promoting patient safety, ease-of-use and reduced clinician error	22
Redo aortic root – complexity vs simplicity with choice of device selected	22
Economic evaluation of automated external defibrillator deployment in public settings for out-of-hospital cardiac arrest: a systematic review	21
Clinical benefit of transcutaneous afferent patterned stimulation (TAPS) in essential tremor patients with high unmet need: a secondary analysis of TAPS studies	21
Optimizing atrial fibrillation detection: a review of subcutaneous cardiac rhythm monitors and consumer technologies	20
The ‘Japanese paradox’ of total hip arthroplasty: where are we going?	19
A profile on the WISE cortical strip for intraoperative neurophysiological monitoring	18
Device profile of the FlareHawk interbody fusion system, an endplate-conforming multi-planar expandable lumbar interbody fusion cage	17
Artificial pancreas systems: experiences from concept to commercialisation	17
A review of transcranial pulse stimulation: innovations in neuromodulation	17
Peregrine system infusion catheter for neurolytic renal denervation in hypertension: an overview of its safety and efficacy	16

Promising next generation left ventricular assist devices: prospects for best treatment opportunities for patients with heart failure	16
Ultra high-frequency ultrasound in lymphatic surgery: the next frontier	16
Robotic assistance in total knee arthroplasty surgery: necessity or trend?	15
Electromagnetic interference from automobile passive keyless entry in cardiovascular implantable electronic devices	15
A software-based lung function assessment tool: an interview with VoiceMed	15
Device profile of the Mobi-C artificial cervical disc: an overview of its safety and efficacy	15
Implantable medical devices for tendon and ligament repair: a review of patents and commercial products	14
MetaHealth: unlocking metaverse technologies in digital healthcare	14
Telemedicine for hypertension management: a paradigm shift from telemonitoring to digital therapeutics	14
An update on locoregional percutaneous treatment technologies in colorectal cancer liver metastatic disease	14
A randomized crossover comparison of the bébé VieScope and direct laryngoscope for pediatric airway management by nurses in medical simulation settings	14
The Ovation Alto platform: extending endovascular treatment beyond short-necked abdominal aortic aneurysms	14
Optimizing the clinical adoption of total joint replacement of the lumbar spine through imaging, robotics and artificial intelligence	14
The potential power of Neuralink – how brain-machine interfaces can revolutionize medicine	13
Digital therapeutics as a new weapon against diseases: focus on the current European legislation and possible therapeutic strategies	13
Complications after peripherally inserted central catheter versus central venous catheter implantation in intensive care unit: propensity score analysis using a nationwide database	13
Percutaneous auricular neuromodulation for postoperative analgesia	13
A review on the impact of cardiac pacing on right ventricular and tricuspid valve function	12
Dynamic versus standard bougies for tracheal intubation with direct or indirect laryngoscopy in simulated or real scenarios: a systematic review and meta-analysis	11
Transforming medical education: the impact of innovations in technology and medical devices	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
Virtual reality therapy combined with physiological monitoring provides effective treatment, with objective metrics, for post-traumatic stress disorder	11
Revolutionizing breast cancer care: the synergy of AI-powered diagnostics, haptic-based biopsy simulators, and advanced surgical techniques	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
Utilization of preoperative EOS imaging to prevent adverse events following total hip arthroplasty	10
Can digital health help improve medication adherence in cardiovascular disease?	10
Differentiating between hepatocellular carcinoma and its mimickers using contrast-enhanced ultrasound with perflubutane microbubbles	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
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
The transvaginal mesh: an overview of indications and contraindications for its use	9
Advances in minimally traumatic retinal laser therapy	9
Tumor treating fields for glioblastoma: opportunities and drawbacks	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
Evaluation of validity and reliability of novel rapid measurement for infundibulopelvic angle: a comparison with PACS system	8
Bone biopsy devices - a patent review	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
In vivo spectroscopy: optical fiber probes for clinical applications	8
Comments on: ‘Two-year outcomes using fast-acting sub-perception therapy for spinal cord stimulation: results of a real-world multicenter study in the United States’	8
Right heart failure after durable left ventricular assist device implantation	8
Association of postoperative acetabular abduction angle with gait asymmetry and adverse reactions following total hip arthroplasty across different surgical approaches	8
Paired associative stimulation to enhance motor outcome in spinal cord injury: a systematic review of first evidence	8
Technological solution for the assessment and rehabilitation of visuo-cognition in Parkinson’s disease	8
Teleophthalmology-enabled devices: bridging the gap in rural eye care	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
Cardiac imaging for the detection of ischemia: current status and future perspectives	8
Device profile of the EVOQUE Eos system for transcatheter mitral valve replacement: a brief narrative review	8

Pulsed field ablation for atrial fibrillation	8
Advancing clinical understanding of surface electromyography biofeedback: bridging research, teaching, and commercial applications	8
Multicenter randomized trial of carpal tunnel release with ultrasound guidance versus mini-open technique	8
Effectiveness of mental health chatbots in depression and anxiety for adolescents and young adults: a meta-analysis of randomized controlled trials	8
Comparison of laryngeal exposure in bed-up-head-elevated Macintosh laryngoscopy vs. supine C-MAC video laryngoscopy: a randomized non-inferiority trial	8
The evolution of endoscopic ultrasound in Saudi Arabia: an expert review of clinical practice and literature	8
Techniques in hybrid repair of aortic arch and thoracoabdominal aortic pathologies	8
From mixed signals to neural code: compensating volume conduction for noninvasive generic neural interfaces	8
Device evaluation: eCoin #x2013; implantable tibial nerve stimulator for overactive bladder	8
Transperineal prostate biopsy using the PrecisionPoint Transperineal Access System for prostate cancer diagnosis – a new standard of care	7
Devices for osteoarthritis symptoms treatment: a patent review	7
Long axial field-of-view PET/CT devices: are we ready for the technological revolution?	7
The role of feedback in the robotic-assisted upper limb rehabilitation in people with multiple sclerosis: a systematic review	7
Endocardial versus epicardial pacing in pacemaker-dependent patients after device extraction: a meta-analysis	7
Therapeutic biliary stents: applications and opportunities	7
Modular cardiac rhythm management system and results of MODULAR ATP trial: an era of personalized device medicine	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
Legal and regulatory challenges in multi-country data-driven projects developing and validating medical AI systems in the EU	7
Mixed reality in interventional radiology: a focus on first clinical use of XR90 augmented reality-based visualization and navigation platform	7
Therapeutic prostate cancer interventions: a systematic review on pubic arch interference and needle positioning errors	7
Tests for the identification of reflex syncope mechanism	6
Breaking the ice through an effective translationality in neurorehabilitation: are we heading to the right direction?	6
Digital colposcopy image analysis techniques requirements and their role in clinical diagnosis: a systematic review	6
Impact of continuous positive airway pressure on the quality of life in patients with sleep apnea	6
Addendum	6
Development and verification of a novel bone collector with automatic size separating function for orthopedics surgery	6
The IlluminOss photodynamic bone stabilization system: novel technology with broad application in orthopaedic fracture fixation	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
A review: artificial intelligence in image-guided spinal surgery	6
Advances in intravascular lithotripsy: mechanisms, devices, and clinical applications	6
Meta-analysis of clinical outcomes in cardiac resynchronisation therapy: his bundle pacing vs biventricular pacing	6
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
The frozen elephant trunk: an overview of hybrid prostheses	6
Pulsed-field ablation: recent advancement in catheter ablation of atrial fibrillation	6
Use of the PRECICE nail for distraction osteogenesis after tumor resection	6
Anatomic feasibility of a novel modular triple-branched endograft for patients with aortic arch pathologies	5
Patient-specific instrumentation makes sense in total knee arthroplasty	5
Comparison of various video laryngoscopes for nasotracheal intubation in simulated difficult airway scenarios: a randomized self-controlled crossover trial	5
Delivery assist catheters for mechanical thrombectomy: a systematic review	5
Letter to the editor on ‘the potential power of neuralink – how brain-machine interfaces can revolutionize medicine’	5
Smaller defibrillation lead diameter is associated with less tricuspid regurgitation: a computational modeling study	5
Relative utility of portable ECG devices in capturing arrhythmias in athletes	5
Intragastric balloons for obesity: critical review of device design, efficacy, tolerability, and unmet clinical needs	5
Ethical concerns regarding a lack of standardized clinical demographic data: an audit of 2023 FDA medical devices	5
Assessing flow diverter porosity: a comparative analysis of quantification techniques based on imaging and simulation	5
Prevention of prosthetic joint infection/surgical site infection: what did the International Consensus Meeting decide?	5
Devices-based treatment of hypertension: the position of the European Society of Hypertension (ESH) 2023 guidelines	5
Vascular access closure devices in neurointerventional procedures: current developments and future directions	5
Visual performance during night driving after intraocular refractive surgery procedures	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
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
Smart clothing for human movement analysis: future application in sport and clinical practice	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
Preparing for the new wave of intrathecal CNS therapies: innovations in drug delivery devices	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
Resource utilization and costs for robotic-assisted and manual total knee arthroplasty – a premier healthcare database study	5
HOPE for a better selection of patients for cardiac contractility modulation	5
Anticipating stroke in patients undergoing transcatheter aortic valve replacement	5
Value of colposcopy with dynamic spectral imaging in the detection and evolution of high-grade cervical lesions	5
Is open anterior advantageous to posterior decompression and reconstruction in fresh A 3 to C 3 /AO type thoracolumbar junction fr	5
Current development and clinical applications of artificial anal sphincter	5
Transcutaneous electric nerve stimulation in restless leg syndrome with cirrhosis: a pilot study	5
Feasibility and patient’s experiences of perioperative telemonitoring in major abdominal surgery: an observational pilot study	5
Is there a role for continuous glucose monitoring beyond diabetes? Emerging applications in new populations	5
A systematic review of follow-up results of additively manufactured customized implants for the pelvic area	5
Comparison of 6-lead smartphone ECG and 12-lead ECG in athletes and a genetic heart disease population	4
GI genius endoscopy module: a clinical profile	4
Development of theranostic wound dressings: harnessing the knowledge of biospecific interactions at the biomaterial interface to promote healing and identify biomarkers	4
Magnetic resonance-guided ultrasound thalamotomy for essential tremor: a review	4
Review of mechanisms of expandable spine surgery devices	4
Failure rates of meniscal repairs during anterior cruciate ligament reconstruction using different meniscal repair devices	4
An update on the evidence for and against the use of intraocular lenses in infants and young children	4
Emerging technologies for combating pandemics	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
Atrial flow regulators for the treatment of pulmonary arterial hypertension: what does the future hold?	4
Efficacy of LMA gastro airway versus endotracheal tube for therapeutic endoscopic retrograde cholangiopancreatography under general anesthesia: a randomized trial	4
Usefulness of insertable cardiac monitors for risk stratification: current indications and clinical evidence	4
Emergency provider preference for powered intraosseous devices and satisfaction with features improving safety, reliability, and ease-of-use	4

Uniportal versus biportal endoscopic spine surgery: a comprehensive review	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
The current use of tissue expanders in breast reconstruction: device design, features, and technical considerations	4
Effectiveness and safety of implantable loop recorder and clinical utility of remote monitoring in patients with unexplained, recurrent, traumatic syncope	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
Anterior Segment Optical Coherence Tomography in Pediatric Ocular Pathology: Imaging Study of 115 eyes	4
Histological examination of tooth-derived biomaterials obtained from different devices	4
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	4
A retrospective study of reported adverse events associated with cardiac stents in Indian population	4
Low profile endografts for the endovascular treatment of abdominal aortic aneurysms	4
Outcomes and evaluation of endoscopic retrograde cholangiopancreatography via Gastro-Laryngeal Tube in adult patients: a prospective randomised control study	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
Deep brain stimulation for Alzheimer’s disease – current status and next steps	4
Minimally invasive capillary blood sampling methods	4
A comparative study of medical device regulation between countries based on their economies	4
Diagnostic value of 24-hour Holter monitoring and conventional electrocardiogram in arrhythmia	4
Assessment of microcirculatory alteration by a vascular occlusion test using near-infrared spectroscopy in pediatric cardiac surgery: effect of cardiopulmonary bypass	4
Prognostic value of renal failure in patients undergoing transvenous lead extraction: single centre experience and systematic review of the literature	4
The evolving role of real-world evidence in medical device approvals in the United States	4
Current and future directions for the use of handheld fundus cameras in telehealth	4
Response to comment on ‘Comparative validation of handheld fractional exhaled nitric oxide measurements’	4
From plugging air leaks to reducing lung volume: a review of the many uses of endobronchial valves	4
The paradox between demanding evidence and seeking personal experience in the adoption of medical devices	3
Recent advances in the use of ultrasound in Crohn’s disease	3
Medical device shelf-life and recalls: navigating healthcare challenges	3
Current status and prospects of robot-assisted spine surgery	3
Ablate and pace strategy for atrial fibrillation: pacing modalities, ablation approaches and impact on patient outcomes	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
99m Tc-labeled and functionalised plasmonic nanoparticles for photo-thermal therapy of primary tumours	3
Emerging transcatheter heart valve technologies for severe aortic stenosis	3
Comparative study of biomodels manufactured using 3D printing techniques for surgical planning and medical training	3
American and European legislation on border medical devices	3
Appropriate use criteria of left atrial appendage closure devices: latest evidences	3
Future potential of responsive neurostimulation for the treatment of Lennox-Gastaut syndrome	3
Ceramic-based 3D printed bone graft in bone tissue reconstruction: a systematic review and proportional meta-analysis of clinical studies	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
Mechanical force optimization for craniofacial distraction osteogenesis: current concepts and future direction — a comprehensive review of the literature	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
Digital screening mammograms: current status and future prospects	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
Current progress of active compliance control strategies and applications in lower limb exoskeleton rehabilitation robots: a narrative review	3
A review of arrhythmia detection based on electrocardiogram with artificial intelligence	3
Sutureless versus transcatheter aortic valve replacement: propensity matched analysis	3
Navigating hypotony challenges with XEN gel implantation	3
The CardioMEMS Heart Failure System for chronic heart failure – a European perspective	3
Hydrophilic biomaterial intravenous hydrogel catheter for complication reduction in PICC and midline catheters	3
Determinants of return to activity and work after carpal tunnel release: a systematic review and meta-analysis	3
Is conduction system pacing a panacea for pacemaker therapy?	3
The added value of lung perfusion scintigraphy semiquantitative measures in post-COVID patients with persistent dyspnea without pulmonary embolism	3
Advancing the future of prosthetic rehabilitation with Regenerative Peripheral Nerve Interface surgery: Questions and opportunities	3
Biomaterial engineering surface to control polymicrobial dental implant-related infections: focusing on disease modulating factors and coatings development	3
Diaphragm neurostimulation in mechanical ventilation: current status and future prospects	3
The modern pharmacological approach to diabetes: innovative methods of monitoring and insulin treatment	3
Device profile of EndoAnchors for aortic stent graft implantation: overview of their safety and efficacy	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
Is there a best choice of equipment for colorectal endoscopic submucosal dissection?	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
Evaluating regulatory oversight through major in vitro diagnostic recalls: a retrospective study of FDA data (2015–2024)	3
Antithrombotic therapy after transcatheter aortic valve implantation	3
Hydrus microstent for the treatment of primary open-angle glaucoma: overview of its safety and efficacy	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
Indications and outcomes of revision total ankle arthroplasty	3
Test-retest reliability of pain extent and pain location using a novel pain drawing analysis software application, on patients with shoulder pain	3
Focused ultrasound: focused on tremor	3
Comment on ‘comparative validation of handheld fractional exhaled nitric oxide measurements’	3
Evaluations of medical device usability during clinical investigations: a scoping review of clinical study protocols	3
A novel design of low-cost hearing aid devices using an efficient lifting filter bank with a modified variable filter	3
Sex differences in 123I-mIBG scintigraphy imaging techniques in patients with heart failure	3
A profile on the CardioMEMS HF system in the management of patients with early stages of heart failure: an update	3
Orphan and paediatric medical devices in Europe: recommendations to support their availability for on-label and off-label clinical indications	2
Catheter ablation of atrial fibrillation: anticipating and avoiding complications	2
Clinical and economic impact of vascular access teams utilizing an IC-ECG-based tip confirmation system for peripherally inserted central catheters	2
Previous, current, and future stereotactic EEG techniques for localising epileptic foci	2
A review of modeling and control of remote-controlled capsule endoscopes	2
Retrograde cerebral perfusion to support aortic arch repair	2
Vascular changes in optical coherence tomography angiography unveiling the depths of dry age-related macular degeneration: a review	2
Advances in the measurement of prosthetic socket interface mechanics: a review of technology, techniques, and a 20-year update	2
Ultrafast 3D echocardiography: get fast or die tryin’	2
Letter to editor regarding “Emerging monitoring techniques in oral appliance therapy for sleep apnea: a narrative review with a focus on mandibular jaw movement analysis”	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
Securing the internet of medical things in remote patient monitoring and the hospital at home: an interview with Stephen Gilbert	2
Post-operative infection with a single-use ureteroscope with real-time intrarenal pressure monitoring vs. all other single-use ureteroscopes	2
Video laryngeal masks in airway management	2
Transcranial magnetic resonance imaging–guided focused ultrasound for neuropathic pain treatment	2
Rapid deployment valves: current position on the market and future directions	2
EVO/EVO+ Visian Implantable Collamer Lenses for the correction of myopia and myopia with astigmatism	2
Blood pressure response with obstructive sleep apnoea treatment: mandibular advancement device versus continuous positive airway pressure	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
An update of interbody cages for spine fusion surgeries: from shape design to materials	2