Expert Review of Medical Devices

Article	Citations
A review on the applications of virtual reality, augmented reality and mixed reality in surgical simulation: an extension to different kinds of surgery	150
Artificially intelligent chatbots in digital mental health interventions: a review	143
Device profile of the percept PC deep brain stimulation system for the treatment of Parkinson’s disease and related disorders	74
Wearable inertial sensors for human movement analysis: a five-year update	62
A novel fast-acting sub-perception spinal cord stimulation therapy enables rapid onset of analgesia in patients with chronic pain	41
Crosslinking hyaluronic acid soft-tissue fillers: current status and perspectives from an industrial point of view	41
Profile of Somryst Prescription Digital Therapeutic for Chronic Insomnia: Overview of Safety and Efficacy	37
Trends and Technologies in Rehabilitation of Foot Drop: A Systematic Review	29
Personal protective equipment during COVID-19 pandemic: a narrative review on technical aspects	29
The Current State of Cervical Endoscopic Spine Surgery: an Updated Literature Review and Technical Considerations	29
Long axial field-of-view PET/CT devices: are we ready for the technological revolution?	28
RETRACTED ARTICLE: Anatomy of a Woebot® (WB001): agent guided CBT for women with postpartum depression	27
MiniMedTM780G Insulin Pump System with smartphone connectivity for the treatment of type 1 diabetes: overview of its safety and efficacy	27
Device profile of the Impella 5.0 and 5.5 system for mechanical circulatory support for patients with cardiogenic shock: overview of its safety and efficacy	26
Device profile of exAblate Neuro 4000, the leading system for brain magnetic resonance guided focused ultrasound technology: an overview of its safety and efficacy in the treatment of medically refrac	24
Device profile of the XVision-spine (XVS) augmented-reality surgical navigation system: overview of its safety and efficacy	23
Differentiation among bio- and augmented- feedback in technologically assisted rehabilitation	23
Design approaches and challenges for biodegradable bone implants: a review	22
Using haptic stimulation to enhance auditory perception in hearing-impaired listeners	22
Transcutaneous auricular vagus nerve stimulators: a review of past, present, and future devices	22
Cardiac contractility modulation for the treatment of moderate to severe HF	22
The future of neuromodulation: smart neuromodulation	21
Mobile health technology in atrial fibrillation	20
Noninvasive vagus nerve stimulation in Parkinson’s disease: current status and future prospects	20
Clinical profile of the SEM Scanner — Modernizing pressure injury care pathways using Sub-Epidermal Moisture (SEM) scanning	20

Computer-assisted surgery in medical and dental applications	19
An update on the improvement of patient eligibility with the use of new generation endografts for the treatment of abdominal aortic aneurysms	19
Hearables, in-ear sensing devices for bio-signal acquisition: a narrative review	18
Mitral valve surgery: current status and future prospects of the minimally invasive approach	18
Minimally invasive capillary blood sampling methods	17
Chronic electroencephalography in epilepsy with a responsive neurostimulation device: current status and future prospects	17
Profile of the Jada® System: the vacuum-induced hemorrhage control device for treating abnormal postpartum uterine bleeding and postpartum hemorrhage	17
Gravitational shunt valves in hydrocephalus to challenge the sequelae of over-drainage	17
A device review of Relivion®: an external combined occipital and trigeminal neurostimulation (eCOT-NS) system for self-administered treatment of migraine and major depressive disorder	16
Percutaneous cryoneurolysis for acute pain management: current status and future prospects	16
Digital PET/CT with 18F-FACBC in early castration-resistant prostate cancer: our preliminary results	16
Clinical role of fluorescence imaging in colorectal surgery - an updated review	16
Closed-loop insulin delivery: update on the state of the field and emerging technologies	16
Wearable electroencephalography for ultra-long-term seizure monitoring: a systematic review and future prospects	16
A review on patient-specific facial and cranial implant design using Artificial Intelligence (AI) techniques	15
Multicenter pragmatic study of carpal tunnel release with ultrasound guidance	15
Sacral neuromodulation for the treatment of overactive bladder: systematic review and future prospects	15
Rehabilitation robotics after stroke: a bibliometric literature review	15
Current perspectives on bioresorbable scaffolds in coronary intervention and other fields	15
Device profile of the Inspiris Resilia valve for aortic valve replacement: overview of its safety and efficacy	14
Tests for the identification of reflex syncope mechanism	14
Implantable cardioverter defibrillators and devices for cardiac resynchronization therapy: what perspective for patients’ apps combined with remote monitoring?	14
Recent advances in wide field and ultrawide field optical coherence tomography angiography in retinochoroidal pathologies	13
Agreement between intraoperative anterior segment spectral-domain OCT and 2 swept-source OCT biometers	13
Negative pressure wound therapy: device design, indications, and the evidence supporting its use	13
Transcranial direct current stimulation combined with peripheral stimulation in chronic pain: a systematic review and meta-analysis	13
Artificial intelligence in medical device software and high-risk medical devices – a review of definitions, expert recommendations and regulatory initiatives	13
Resilient design: decentralized trials recovered faster from the impact of COVID-19 than traditional site-based designs	13
Advances in CSF shunt devices and their assessment for the treatment of hydrocephalus	12
Antimicrobial and resource utilization with T2 magnetic resonance for rapid diagnosis of bloodstream infections: systematic review with meta-analysis of controlled studies	12
Reuse of pacemakers and implantable cardioverter-defibrillators: systematic review, meta-analysis and quality assessment of the body of evidence	12
Analytical review on the biocompatibility of surface-treated Ti-alloys for joint replacement applications	12
Pacing devices to treat bradycardia: current status and future perspectives	12
From the Evolut Pro to the Evolut FX self-expanding transcatheter aortic valve replacement systems: current status and future perspectives	11
Deep TMS H7 Coil: Features, Applications & Future	11
Use of XyCAM RI for Noninvasive Visualization and Analysis of Retinal Blood Flow Dynamics During Clinical Investigations	11
Preparing healthcare, academic institutions, and notified bodies for their involvement in the innovation of medical devices under the new European regulation	11
Acute postoperative pain management with percutaneous peripheral nerve stimulation: the SPRINT neuromodulation system	11
Transcatheter edge-to-edge mitral valve repair in mitral regurgitation: current status and future prospects	11
Diagnostic yield and safety of the ProCore versus the standard EBUS-TBNA needle in subjects with suspected sarcoidosis	11
Continuous glucose monitoring in persons with type 2 diabetes not using insulin	11
Six Month Interim Outcomes from SECURE: A Single arm, Multicenter, Prospective, Clinical Study on a Novel Minimally Invasive Posterior Sacroiliac Fusion Device	10
A review of arrhythmia detection based on electrocardiogram with artificial intelligence	10
The application of indocyanine green (ICG) and near-infrared (NIR) fluorescence imaging for assessment of the lymphatic system in reconstructive lymphaticovenular anastomosis surgery	10
The role of robotic technology in minimally invasive surgery for mitral valve disease	10
Stroke and neurointervention in the COVID-19 pandemic: a narrative review	9
The realization of robotic neurorehabilitation in clinical: use of computational intelligence and future prospects analysis	9
A new approach to non-mydriatic portable fundus imaging	9
Digital health; what do we mean by clinical validation?	9
Recent advances in multimodality imaging of the tricuspid valve	9

Continuous monitoring of vital signs with the Everion biosensor on the surgical ward: a clinical validation study	9
Surface modification of ureteral stents: development history, classification, function, and future developments	9
An update on the ovation abdominal stent graft for the treatment of abdominal aortic aneurysms: current evidence and future perspectives	8
A novel noncontact high-resolution charge density mapping system to guide ablation of complex atrial arrhythmias: overview of device technology and application	8
Management of out-of hospital cardiac arrest patients with extracorporeal cardiopulmonary resuscitation in 2021	8
Multicenter randomized trial of carpal tunnel release with ultrasound guidance versus mini-open technique	8
Leadless pacemaker versus transvenous single-chamber pacemaker therapy: peri-procedural aspects, utilization of medical resources and patient acceptance	8
Mortality in mechanically ventilated patients with COVID-19: a systematic review	8
Deep brain stimulation programming strategies: segmented leads, independent current sources, and future technology	8
Cardiac implantable electronic devices and cybersecurity	8
Agreement between anterior segment parameters obtained by a new ultrasound biomicroscopy and a swept-source fourier-domain anterior segment optical coherence tomography.	8
Digital healthcare technologies: Modern tools to transform prosthetic care	8
Transcutaneous auricular vagus nerve stimulation effects on inflammatory markers and clinical evolution of patients with COVID-19: a pilot randomized clinical trial	7
OverStitch Sx Endoscopic suturing system in minimally invasive endoscopic procedures: overview of its safety and efficacy and comparison to oversticthTM	7
Device profile of the EXALT Model D single-use duodenoscope for endoscopic retrograde cholangiopancreatography: overview of its safety and efficacy	7
Potential strategies to prevent encrustations on urinary stents and catheters – thinking outside the box: a European network of multidisciplinary research to improve urinary stents (ENIUS) initiative	7
Advances in additive manufacturing processes and their use for the fabrication of lower limb prosthetic devices	7
In vivo spectroscopy: optical fiber probes for clinical applications	7
Comparison of clinical efficacy of three different dentin matrix biomaterials obtained from different devices	7
Arrhythmogenic syncope leading to cardiac rhythm management procedures during COVID-19 lockdown	7
Caloric and galvanic vestibular stimulation for the treatment of Parkinson’s disease: rationale and prospects	7
Artificial intelligence in retinal imaging: current status and future prospects	7
Toward improving functional recovery in spinal cord injury using robotics: a pilot study focusing on ankle rehabilitation	7
Video laryngeal masks in airway management	7
Hemolysis during short-term mechanical circulatory support: from pathophysiology to diagnosis and treatment	7
Steering light in fiber-optic medical devices: a patent review	6
Outcomes after mechanical versus manual chest compressions in eCPR patients	6
Prevention and management of endocarditis after transcatheter pulmonary valve replacement: current status and future prospects	6
Reliability and validity of smartphone applications to measure the spinal range of motion: A systematic review	6
EVO/EVO+ Visian Implantable Collamer Lenses for the correction of myopia and myopia with astigmatism	6
Bimodular femoral stems in primary total hip arthroplasty	6
An insight into Transfemoral Prostheses: Materials, modelling, simulation, fabrication, testing, clinical evaluation and performance perspectives	6
Repeatability and reproducibility of the galilei G6 and its agreement with the pentacam® AXL in optical biometry and corneal tomography	6
Determinants of return to activity and work after carpal tunnel release: a systematic review and meta-analysis	6
Reliability and applicability of a low-cost, camera-based gait evaluation method for clinical use	6
Magnetic resonance enterography in Crohn’s disease patients: current state of the art and future perspectives	6
Feasibility and patient’s experiences of perioperative telemonitoring in major abdominal surgery: an observational pilot study	6
Music-based techniques and related devices in neurorehabilitation: a scoping review	6
Delivering epilepsy care in low-resource settings: the role of technology	6
Percutaneous laser ablation of cervical metastatic lymph nodes in papillary thyroid carcinoma: clinical efficacy and anatomical considerations	5
Active esophageal cooling during radiofrequency ablation of the left atrium: data review and update	5
Development of theranostic wound dressings: harnessing the knowledge of biospecific interactions at the biomaterial interface to promote healing and identify biomarkers	5
The transvaginal mesh: an overview of indications and contraindications for its use	5
Endovascular treatment of extracranial carotid artery stenosis using a dual-layer micromesh stents: a systematic review	5
Intraosseous vascular access in emergency and trauma settings: a comparison of the most universally used intraosseous devices	5
Device profile of the eversense continuous glucose monitoring system for glycemic control in type-1 diabetes: overview of its safety and efficacy	5
Device profile of the VEST for external support of SVG Coronary artery bypass grafting: historical development, current status, and future directions	5
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	5
Transcatheter valve-in-valve implantation for degenerated bioprosthetic aortic and mitral valves – an update on indications, techniques, and clinical results	5
Device profile of the tack endovascular system® for the treatment of peripheral arterial disease: overview of safety and efficacy	5
Interference of cardiovascular implantable electronic devices by static electric and magnetic fields	5
EEG modulation by different transcranial direct current stimulation (tDCS) montages: a randomized double-blind sham-control mechanistic pilot trial in healthy participants	5
Mobile applications in peripheral arterial disease (PAD): a review and introduction of a new innovative telemonitoring application: JBZetje	5
Antithrombotic therapy after transcatheter aortic valve implantation	5
Long-term safety and efficacy of breast biopsy markers in clinical practice	5
Reflection efficiencies of AnaConDa-S and AnaConDa-100 for isoflurane under dry laboratory and simulated clinical conditions: a bench study using a test lung	5
Technical considerations for the management of segmental osseous defects with an internal bone transport nail	5
Uniportal versus biportal endoscopic spine surgery: a comprehensive review	5
Mechanical filtration of the cerebrospinal fluid: procedures, systems, and applications	5
Single-lead VDD pacing: a literature review on short-term and long-term performance	5
Prostate-specific membrane antigen-directed imaging and radioguided surgery with single-photon emission computed tomography: state of the art and future outlook	5
Can single-use bronchoscopes help prevent nosocomial COVID-19 infections?	5
HeartlogicTM: ready for prime time?	4
Mechanical complications after total knee arthroplasty	4
Early revision events among patients with a three dimensional (3D) printed cellular titanium or PEEK (polyetheretherketone) spinal cage for single-level lumbar spinal fusion	4
Design of lower limb prosthetic sockets: a review	4
Data-driven monitoring in patients on left ventricular assist device support	4
Prevention and repair of orthodontically induced root resorption using ultrasound: a scoping review	4
US Guided Si.La.D. A new technique for minimally invasive pilonidal disease treatment, using ultrasound guided laser ablation	4
Update on the TREO endograft device: overview of its safety and efficacy	4
Emerging technologies for combating pandemics	4
Progress in large field-of-view interventional planar scintigraphy and SPECT imaging	4
Role of real-world digital data for orthopedic implant automated surveillance: a systematic review	4
The new generation double layered flow diverters for endovascular treatment of intracranial aneurysms: current status of ongoing clinical uses	4
FlowTriever Retrieval System for the treatment of pulmonary embolism: overview of its safety and efficacy	4
Agreement of predicted intraocular lens power using swept-source optical coherence tomography and partial coherence interferometry	4
Updates in immunocompatibility of biomaterials: applications for regenerative medicine	4
The role of feedback in the robotic-assisted upper limb rehabilitation in people with multiple sclerosis: a systematic review	4
The lateral arm device for mammographic breast procedures: overview of its uses, safety, and efficacy	4
Minimizing re-excision after breast conserving surgery – a review of radiofrequency spectroscopy for real-time, intraoperative margin assessment	4

Subcutaneous cardiac rhythm monitors: state of the art review	4
Intragastric balloons for obesity: critical review of device design, efficacy, tolerability, and unmet clinical needs	4
Evaluating adaptation effect in real versus virtual reality environments with people who stutter	4
Digital PET and detection of recurrent prostate cancer: what have we gained, and what is still missing?	4
Wearable devices for gait and posture monitoring via telemedicine in people with movement disorders and multiple sclerosis: a systematic review	4
Comparison of clinical effectiveness of fenestrated and conventional pedicle screws in patients undergoing spinal surgery: a systematic review and meta-analysis	4
The current status of breakthrough devices designation in the United States and innovative medical devices designation in Korea for digital health software	4
Device profile of Nerivio for the acute and preventive treatment of episodic or chronic migraine in patients 12 years and older	4
Test – re-test reliability and concurrent validity of cervical active range of motion in young asymptomatic adults using a new inertial measurement unit device	4
Recommendations for the design and implementation of an Early Feasibility Studies program for medical devices in the European Union	4
Recent advances in the tools available for atrial fibrillation ablation	4
Physiological principles of Starling-like control of rotary ventricular assist devices	4
Baska mask versus endotracheal tube in laparoscopic cholecystectomy surgery: a prospective randomized trial	4
Prolonged care delivery time and reduced rate of electrophysiological procedures during the lockdown period due to Covid-19 outbreak	3
Devices-based treatment of hypertension: the position of the European Society of Hypertension (ESH) 2023 guidelines	3
A systematic review of follow-up results of additively manufactured customized implants for the pelvic area	3
The Ovation Alto platform: extending endovascular treatment beyond short-necked abdominal aortic aneurysms	3
Truss implant technology™ for interbody fusion in spinal degenerative disorders: profile of advanced structural design, mechanobiologic and performance characteristics	3
Ankle sprain bracing solutions and future design consideration for civilian and military use	3
Feasibility of a wearable biosensor device to characterize exercise and sleep in neurology residents	3
Device profile of the Zephyr endobronchial valve in heterogenous emphysema: overview of its safety and efficacy	3
An update of interbody cages for spine fusion surgeries: from shape design to materials	3
Evaluation of the safety and effectiveness of a sealant hemostatic patch for preventing cerebrospinal fluid leaks in cranial surgery	3
En face swept-source optical coherence tomography angiography choroidal vasculography (CVG) a tool to discriminate choroidal abnormalities in polypoidal choroidal vasculopathy	3
A review of modeling and control of remote-controlled capsule endoscopes	3
Effectiveness and safety of implantable loop recorder and clinical utility of remote monitoring in patients with unexplained, recurrent, traumatic syncope	3
Safety and efficacy of repeat transcatheter aortic valve replacement for the treatment of transcatheter prosthesis dysfunction	3
A realistic way to investigate the design, and mechanical properties of flow diverter stents	3
Prevention of prosthetic joint infection/surgical site infection: what did the International Consensus Meeting decide?	3
Through-the-needle biopsy of pancreatic cystic lesions: current evidence and implications for clinical practice	3
[18F]FDG PET-TC radiomics and machine learning in the evaluation of prostate incidental uptake	3
Appropriate use criteria of left atrial appendage closure devices: latest evidences	3
Laser balloon in pulmonary vein isolation for atrial fibrillation: current status and future prospects	3
Research progress of portable extracorporeal membrane oxygenation	3
How to assess the risks associated with the usage of a medical device based on predictive modeling: the case of an anemia control model certified as medical device	3
The evolution of PET imaging in renal, bladder, upper urinary tract urothelial, testicular and penile carcinoma – Today’s impact, tomorrow’s potential	3
Artificial pancreas systems: experiences from concept to commercialisation	3
Devices for transcatheter mitral valve repair: current technology and a glimpse into the future	3
Battery life of cardiac implantable electronic devices explanted in funeral homes: a potential resource for underserved nations	3
Robotic navigation during spine surgery: an update of literature	3
Lenstar LS900 vs EchoScan US-800: comparison between optical and ultrasound biometry with and without contact lenses and its relationship with other biometric parameters	3
Radar reflector guided axillary surgery in node positive breast cancer patients	3
HOPE for a better selection of patients for cardiac contractility modulation	3
The value of using real-world evidence as a source of clinical evidence in the European medical device regulations: a mixed methods study	3
Axial length measurement failure rates using optical biometry based on swept-source OCT in cataractous eyes	3
Previous, current, and future stereotactic EEG techniques for localising epileptic foci	3
Repeatability and agreement of corneal thickness measurements by three methods of pachymetry in small incision lenticule extraction eyes	3
Efficacy and safety of mechanical thrombectomy in acute stroke patients with pre-morbid disability	3
Regulatory requirements and optimization of multiple criteria decision analysis to quantify the benefit-risk assessment of medical devices	3
Mechanical ventilation in patients with acute respiratory distress syndrome: current status and future perspectives	3
When is a wearable defibrillator indicated?	3
The efficacy and safety of patient-specific instrumentation in primary total knee replacement: a systematic review and meta-analysis	3
Total-body PET/CT: how will it change theranostics in oncology?	3
Profile of the Ovation ALTO abdominal stent graft for the treatment of abdominal aortic aneurysms: overview of its safety and efficacy	3
The evolution of long-term pediatric ventricular assistance devices: a critical review	3
Anticipating and preventing complications in spinal cord stimulator implantation	2
Procedural embolic protection strategies for carotid artery stenting: current status and future prospects	2
An update on locoregional percutaneous treatment technologies in colorectal cancer liver metastatic disease	2
Bridging the gap in the symptomatic heart failure patient journey: insights from the Italian scenario	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
Contact force sensors in minimally invasive catheters: current and future applications	2
Intraoperative OCT microscopy in 3D	2
Diagnostic accuracy of liver stiffness on two-dimensional shear wave elastography for detecting clinically significant portal hypertension: a meta-analysis	2
Ambient assisted living systems for falls monitoring at home	2
Thyroid cancer diagnosis with transdermal probe 22G U/S versus EBUS-convex probe TBNA-B 22G and 19G: pros and cons	2
Comparative analysis of measurements of the anterior segment and the axial length parameters of the eyeball obtained with optical and ultrasound technique	2
Resource utilization and costs for robotic-assisted and manual total knee arthroplasty – a premier healthcare database study	2
Comprehensive strategies to minimize radiation exposure during Interventional electrophysiology procedures: state-of-the-art review	2
Recent advances in the use of ultrasound in Crohn’s disease	2
Advances in the measurement of prosthetic socket interface mechanics: a review of technology, techniques, and a 20-year update	2
Analysis of study designs and primary outcome measures in clinical trials of investigational suture materials	2
Singular secular Kuznets-like period realized amid industrial transformation in US FDA medical devices: a perspective on growth from 1976 to 2020	2
Anatomy of a Woebot® (WB001): agent guided CBT for women with postpartum depression	2
Biomaterial engineering surface to control polymicrobial dental implant-related infections: focusing on disease modulating factors and coatings development	2
Lung detection and severity prediction of pneumonia patients based on COVID-19 DET-PRE network	2
Why did the number of US FDA medical device guidelines begin to rise in the mid-2010s? A perspective	2
Advantages and limitations of mobile-bearing unicompartmental knee arthroplasty: an overview of the literature	2
Correlative effect between sac regression and clinical outcomes following endovascular repair in abdominal aortic aneurysm: fact or myth?	2
The FlowOx device for the treatment of peripheral artery disease: current status and future prospects	2
Agreement of anterior segment measurements between four diagnostic imaging devices in myopic patients	2
Comparison of methods for delivering cardiac resynchronization therapy: electrical treatment targets and mechanisms of action	2
Patient-specific instrumentation makes sense in total knee arthroplasty	2
Comparison and convergence of compartment syndrome techniques: a narrative review	2
Device profile of the Ambicor two-piece inflatable penile prosthesis for treatment of erectile dysfunction: overview of its safety and efficacy	2
Implantable medical devices for tendon and ligament repair: a review of patents and commercial products	2
Selection criteria in the era of perfect competition for drug-eluting stents - a survey of interventional cardiologists in Japan: the selection-DES study	2
Limited value of current shoulder arthroplasty registries in evidence-based shoulder surgery: a review of 7 national registries	2
The current state, challenges, and future directions of deep brain stimulation for obsessive compulsive disorder	2
Deep brain stimulation for Alzheimer’s disease – current status and next steps	2
Validation of diagnostic accuracy of a handheld, smartphone-based rhythm recording device	2
Towards an evaluation framework for medical device-integrated electronic medical record	2
Usefulness of insertable cardiac monitors for risk stratification: current indications and clinical evidence	2
Effect of energy-based devices on post-operative parathyroid function and blood calcium levels after total thyroidectomy	2
Troubleshooting the difficult left ventricular lead placement in cardiac resynchronization therapy: current status and future perspectives	2
Remote monitoring of implantable electronic devices to predict heart failure decompensation	2