Expert Review of Medical Devices

Guidance for avoiding patient pain and discomfort during transurethral cystoscopy
Desai AP, Smith AB and Lotan Y
Cystoscopy is one of the most commonly performed invasive urological procedures, serving as a critical diagnostic and surveillance tool in urology, particularly for patients with bladder cancer and hematuria. Despite its routine use in outpatient settings, the procedure is frequently associated with significant patient-reported discomfort, which may adversely affect compliance with surveillance protocols and overall quality of care.
Echocardiographic assessment after transcatheter aortic valve replacement
Gu K, Museedi A, Agarwal V and Hahn RT
Aortic stenosis is one of the most common valvular diseases, especially in the elderly. Transcatheter aortic valve replacement (TAVR) has become a mainstay treatment of severe, symptomatic aortic stenosis. Echocardiography remains the critical diagnostic tool for procedural success, complications, and follow-up.
Advances in minimally traumatic retinal laser therapy
Yao CS and Paulus YM
Retinal laser therapy has played a key role in managing numerous retinal vascular diseases, such as diabetic retinopathy, retinal vein occlusion, macular edema, and central serous chorioretinopathy since the 1960s. While conventional laser approaches are shown to be effective, they have been associated with permanent tissue scarring and vision loss. Recent advancements aim to minimize this collateral damage, using subdamaging or selective energy delivery to preserve healthy retina while balancing treatment benefit.
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
Germano JA, Gupta A, Varughese B, Ruppenkamp J and Diaz R
This study evaluates clinical and economic outcomes among patients who received cementless, medial collared, triple-tapered hip stem (TTS) compared to other hip systems (non-TTS) for solely the posterior approach in THA.
Smaller defibrillation lead diameter is associated with less tricuspid regurgitation: a computational modeling study
Oks D, Schaller RD, Mason PK and Sack KL
Tricuspid regurgitation (TR) adversely impacts mortality and hospitalizations. Transvenous pacemaker and defibrillator leads are associated with worsening TR, underscoring the need for lead designs that minimize adverse tricuspid valve interference.
Comparison of mid-term survival of uncemented total knee arthroplasties with modular tibial components made of porous tantalum vs. cemented total knee arthroplasties
Godicelj Ž, Kastelic J, Levašič V, Krajnc Z, Moličnik A, Novak I, Naranđa J, Zajc J and Fokter SK
Cementless total knee arthroplasties (TKAs) with porous tantalum tibial components were developed to improve fixation and reduce implant failure rates in younger, active patients. However, mid-term outcomes remain uncertain. This retrospective study compared survival rates of cementless TKAs with porous tantalum posterior-stabilized (PS) modular tibial components to cemented PS components from the same implant system, using revision for aseptic loosening as the endpoint.
Ultrafast 3D echocardiography: get fast or die tryin'
Villemain O
An update on the evidence for and against the use of intraocular lenses in infants and young children
DeHart TL, Trivedi RH and Wilson ME
One highly discussed topic in managing pediatric cataracts is determining when is it appropriate to implant an intraocular lens (IOL) in infants and young children who require cataract surgery. IOLs are an artificial replacement to the natural lens that may offer great visual benefit, but there are many factors to consider in the infant and young child population.
A review on the impact of cardiac pacing on right ventricular and tricuspid valve function
Liew A, Wijesuriya N, Howell S, de Vere F, Niederer S and Rinaldi CA
Conventional transtricuspid pacing including right ventricular pacing (RVP), cardiac resynchronization therapy (CRT), and implantable cardiac defibrillator (ICD) constitute the mainstay of device therapy for various indications relating to cardiac arrhythmia. However, devices with transtricuspid leads have been associated with tricuspid regurgitation (TR) progression which may exacerbate or lead to right ventricular dysfunction (RVD). Meanwhile, the impact of newer pacing modalities such as leadless pacing and conduction system pacing on TR progression and RVD is not well defined.
Technology, pharmacology, and clinical outcomes of sirolimus coated balloons for peripheral arterial interventions
Khonkarn R, Ramadani P, Qi S, Ali T and Krokidis M
Peripheral arterial intervention is a rapidly evolving field with a significant impact on an aging population.
Post-market surveillance of ophthalmic implants: role of real-world evidence
Gurnani B and Kaur K
Ophthalmic implants including intraocular lenses, glaucoma drainage devices, corneal inlays, and keratoprosthesis are transformative in vision restoration. While randomized controlled trials (RCTs) establish pre-market safety and efficacy, they are limited in scope, duration, and generalizability. Post-market surveillance leveraging real-world evidence (RWE) has become indispensable to detect long-term complications, refine clinical practice, and support regulatory oversight.
Medical device shelf-life and recalls: navigating healthcare challenges
Thakor P, Shah S, Shah A and Singh OV
Medical devices are integral to the United States (US) healthcare sector, supporting the prevention, diagnosis, monitoring, and treatment of various medical conditions. Ranging from simple bandages to advanced diagnostic tools, these devices are key to delivering quality patient care. Among the critical parameters ensuring their safety and effectiveness is shelf-life, which defines the duration during which a device remains stable and functional as claimed on its label.
Advancing diagnostics in Pythium insidiosum keratitis: the emerging role of point-of-care imaging and biosensor-based detection devices
Gurnani B and Kaur K
Pythium insidiosum keratitis (PIK) is a rapidly progressive, aggressive corneal infection that closely mimics fungal keratitis but fails to respond to conventional antifungal therapy. Misdiagnosis and delayed intervention frequently result in poor outcomes, including high rates of therapeutic keratoplasty and irreversible vision loss. Timely and accurate identification is therefore vital, yet conventional microbiological methods are slow, and histopathology is invasive and often inconclusive. Recent advances in imaging, molecular diagnostics, and biosensor technology are revolutionizing diagnostic possibilities.
Optimizing atrial fibrillation detection: a review of subcutaneous cardiac rhythm monitors and consumer technologies
Poliner M, Bhutta R, Gomaa M and Afzal MR
Subcutaneous cardiac rhythm monitors (SCRMs) are utilized for prolonged continuous rhythm monitoring to evaluate for arrhythmias in the setting of infrequent palpitations, syncope, and cryptogenic stroke. Managing SCRMs requires practices to screen incoming data and adjudicate electrocardiograms (ECG) for accuracy when arrhythmias are detected. The growing utilization of SCRMs has led to increased resource demands, exacerbated by false-positive (FP) episodes and data deluge. To address this issue, manufacturers have developed advanced algorithms with some integrating artificial intelligence (AI) into their software. In parallel, providers can implement customized device settings to potentially further reduce FP alerts.
An overview of the t:slim X2 and Mobi insulin pumps with Control-IQ technology: patient safety and device efficacy
Sawyer A, Forlenza GP and Wadwa RP
Type 1 diabetes is a chronic disease requiring lifelong intensive insulin treatment. Automated insulin delivery (AID) systems such as Tandem Control-IQ allow for automatic adjustment of insulin delivery and can help improve glycemic outcomes.
Swiftsure complete care system in intubated adults: a feasibility study
Almeida VFA, Reuter Pimenta A, Lara-Erazo V, Karki D, Rodriguez-Patarroyo F, Semeia J, Duncan H, Filipovic N, Meyer D and Gama de Abreu M
Mechanically ventilated patients are at risk of respiratory complications, which may be reduced by proper oral care. The oral cleaning device (Swishkit, Swiftsure, Vancouver, Canada) was developed to facilitate cleansing, moisturization, and debris removal in intubated patients. We aimed to evaluate the feasibility and usability of this device in adult intensive care patients.
Recent advances in device therapies for resistant hypertension. Where do we stand?
de Leeuw PW and Kroon AA
Device-based treatment of patients with resistant hypertension has become an important adjunct to medical therapy, although its place in clinical practice has not yet been fully established. The present minireview discusses the current state of affairs of such treatment modalities. We searched the literature in PubMed and MEDLINE for all relevant papers.
Evaluating the effectiveness and safety of a remote electrical neuromodulation wearable device in treating chronic and episodic migraine: a retrospective, observational real-world evidence from India
Charugulla SN, Dhore MR, Stark-Inbar A, Kotak BP and Singh S
The remote electrical neuromodulation (REN) wearable device offers a noninvasive, non-pharmacological option for migraine management, but its role in Indian healthcare remains unexplored.
Role of multimodality imaging in cardiac implantable electronic devices related infection and infective endocarditis
Khayata M, Goff Z, Gordon S, Callahan T, Elgharably H, Unai S and Xu B
Infective endocarditis (IE) is a serious and increasingly recognized condition, associated with significant morbidity and mortality. The diagnosis of IE is more challenging in patients with implanted cardiac devices such as cardiac implantable electronic devices, left ventricular assist devices, and left atrial appendage occlusion devices.
Cerebral embolic protection devices in transcatheter aortic valve implantation: a systematic review and meta-analysis of randomized controlled trials
Waseem MH, Ul Abideen Z, Cheema AH, Osama M, Javed Khan H, Farid R, Rehman N, Aimen S and Thada PK
This meta-analysis aimed to assess the efficacy and safety of cerebral embolic protection devices (CEPDs) in patients undergoing transcatheter aortic valve implantation (TAVI).
A comprehensive review of biliary cannulation techniques in endoscopic retrograde cholangiopancreatography
Gadour E, Almuhaidb A, Crinò SF, Stasi E, Brigida M, Dell'anna A, Spampinato M, Cotsoglou C, Dinelli ME, Donatelli G, Dell'anna G and Facciorusso A
Successful biliary cannulation is crucial for the efficacy of endoscopic retrograde cholangiopancreatography (ERCP). Failure to achieve cannulation can lead to procedure failure, highlighting the importance of mastering various cannulation techniques, particularly in challenging cases.