Expert review of medical devices最新文献

Ultrafast 3D echocardiography: get fast or die tryin'. 超快3D超声心动图：要么快，要么死。

IF 2.7

Expert review of medical devices Pub Date : 2025-10-09 DOI: 10.1080/17434440.2025.2573418

Olivier Villemain

引用次数: 0

Comparison of mid-term survival of uncemented total knee arthroplasties with modular tibial components made of porous tantalum vs. cemented total knee arthroplasties. 多孔钽模数胫骨假体与骨水泥全膝关节置换术的中期生存率比较。

IF 2.7

Expert review of medical devices Pub Date : 2025-10-06 DOI: 10.1080/17434440.2025.2569571

Žiga Godicelj, Jure Kastelic, Vesna Levašič, Zmago Krajnc, Andrej Moličnik, Igor Novak, Jakob Naranđa, Jan Zajc, Samo K Fokter

{"title":"Comparison of mid-term survival of uncemented total knee arthroplasties with modular tibial components made of porous tantalum vs. cemented total knee arthroplasties.","authors":"Žiga Godicelj, Jure Kastelic, Vesna Levašič, Zmago Krajnc, Andrej Moličnik, Igor Novak, Jakob Naranđa, Jan Zajc, Samo K Fokter","doi":"10.1080/17434440.2025.2569571","DOIUrl":"10.1080/17434440.2025.2569571","url":null,"abstract":"Background & objectives: 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.Materials and methods: From January 2017 to November 2021, 899 TKAs were performed at a single tertiary center for osteoarthritis. Of these, 645 (71.7%) were cemented and 254 (28.3%) cementless. Median BMI was similar in both groups (30.0 kg/m2 vs 31.0 kg/m2; p = 0.814). Cementless recipients were younger (median 66.0 vs. 72.0 years; p < 0.001). Follow-up continued through 31 December 2023.Results: Seven-year survival was lower in the cementless group (97.1%, 95% CI 94.9-99.3) vs. cemented group (97.8%, 95% CI 96.6-99.0). Tibial component loosening led to 5 revisions in the cementless group vs. 2 revisions in the cemented group (p < 0.05). Two cementless cases involved tibial tray fractures. Overall, 86 patients (9.6%) died of unrelated causes.Conclusions: Cementless porous tantalum TKAs had inferior mid-term performance for aseptic loosening, prompting their discontinuation at our institution.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1-9"},"PeriodicalIF":2.7,"publicationDate":"2025-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145214582","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

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. 评估远程电神经调节可穿戴设备治疗慢性和发作性偏头痛的有效性和安全性：来自印度的回顾性观察性现实证据。

IF 2.7

Expert review of medical devices Pub Date : 2025-10-02 DOI: 10.1080/17434440.2025.2566742

Sujeet Narayan Charugulla, Mayank Ravindra Dhore, Alit Stark-Inbar, Bhavesh Prabhudas Kotak, Sukhpreet Singh

{"title":"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.","authors":"Sujeet Narayan Charugulla, Mayank Ravindra Dhore, Alit Stark-Inbar, Bhavesh Prabhudas Kotak, Sukhpreet Singh","doi":"10.1080/17434440.2025.2566742","DOIUrl":"10.1080/17434440.2025.2566742","url":null,"abstract":"Background: The remote electrical neuromodulation (REN) wearable device offers a noninvasive, non-pharmacological option for migraine management, but its role in Indian healthcare remains unexplored.Research design and methods: This retrospective, observational, real-world analysis included patients prescribed REN (Nerivio®) by neurologists across India. Deidentified data were collected via the Portea Medical patient support program, with a three-month follow-up. The primary outcome assessed the effectiveness and safety of the device. Secondary outcomes included changes in headache frequency and medication regimes.Results: The study population included 1033 patients (mean [SD] age: 38.8 [13] years; 74.8% female; 84.6% with chronic migraine). At two hours post-treatment with REN, 57.3% reported pain relief, 29.4% achieved pain freedom, 47.1% experienced relief from functional disability, and 26.1% reported complete freedom from functional disability. At three months, 70.3% found REN effective. The mean visual analog scale score for pain severity decreased by 2.3 units (p < 0.001). No adverse events occurred in 38.7% of patients. REN usage significantly reduced monthly headache days, frequency of oral medication use, and medicine dosage.Conclusion: REN is an effective, safe, and well-tolerated non-pharmacological option for migraine management in India. However, long-term studies are necessary to extend these findings across diverse populations.Trial registration: ClinicalTrials.gov (CTRI/2024/11/076750).","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1-7"},"PeriodicalIF":2.7,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145188139","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Advancing gait rehabilitation through wearable technologies: current landscape and future directions. 通过可穿戴技术推进步态康复：现状和未来方向。

IF 2.7

Expert review of medical devices Pub Date : 2025-10-01 Epub Date: 2025-08-14 DOI: 10.1080/17434440.2025.2546476

Jenny Bartloff, Francesco Lanotte, Megan K O'Brien, Arun Jayaraman

{"title":"Advancing gait rehabilitation through wearable technologies: current landscape and future directions.","authors":"Jenny Bartloff, Francesco Lanotte, Megan K O'Brien, Arun Jayaraman","doi":"10.1080/17434440.2025.2546476","DOIUrl":"10.1080/17434440.2025.2546476","url":null,"abstract":"Introduction: Gait impairments due to neurologic injury or disease significantly compromise mobility and quality of life. Traditional gait rehabilitation approaches, though grounded in motor learning principles, often face limitations in delivering sufficient intensity, specificity, and ecological validity.Areas covered: This review considers the landscape of wearable technologies for gait rehabilitation, including robotic exoskeletons, neuromodulation, and sensory augmentation platforms such as virtual/augmented reality (VR/AR) and biofeedback. Literature was identified through comprehensive searches of clinical studies, systematic reviews, and feasibility trials. The paper explores mechanisms, clinical applications, and evidence supporting their use in gait rehabilitation for neurological populations.Expert opinion: Wearable technologies will continue to transform neurorehabilitation by enabling more precise, consistent, and personalized therapy both in the clinic and at home. However, adoption can be limited by high costs, usability challenges, fragmented evidence, and limited integration into clinical workflows. Realizing their full potential will require strong interdisciplinary collaboration and structured training pathways to support clinical use. Continued advances in hardware and software, including AI integration, will further enhance their impact by enabling more adaptive and efficient care. In five years, we anticipate a major integration of wearable systems as part of data-driven rehabilitation ecosystems, improving access and long-term recovery outcomes.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1105-1116"},"PeriodicalIF":2.7,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144818901","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Towards wearable blood pressure monitoring: an interview with George Stergiou. 迈向可穿戴式血压监测：采访George Stergiou。

IF 2.7

Expert review of medical devices Pub Date : 2025-10-01 Epub Date: 2025-09-19 DOI: 10.1080/17434440.2025.2558202

George S Stergiou

引用次数: 0

Imaging modalities in lymphatic surgery. 淋巴手术的成像方式。

IF 2.7

Expert review of medical devices Pub Date : 2025-10-01 Epub Date: 2025-08-29 DOI: 10.1080/17434440.2025.2554760

Rohini L Kadle, Albert H Chao

{"title":"Imaging modalities in lymphatic surgery.","authors":"Rohini L Kadle, Albert H Chao","doi":"10.1080/17434440.2025.2554760","DOIUrl":"10.1080/17434440.2025.2554760","url":null,"abstract":"Introduction: Diagnosis and treatment of lymphedema revolve around microsurgical and supermicrosurgical techniques, and various imaging modalities are integral to these techniques. Here, we discuss both the historic and novel imaging modalities in the diagnosis, pre-operative management, intra-operative period, and post-operative analysis of lymphedema.Areas covered: Lymphoscintigraphy has been the gold-standard for diagnosis of lymphedema, although with poor image resolution, it has fallen out of favor. Indocyanine green lymphography is a versatile imaging technique that is both portable and user-friendly. It can be used both for pre-operative planning and intra-operative confirmation of anastomotic patency. Magnetic resonance lymphography, while more expensive and technically challenging, provides information on lymphatics as well as surrounding vasculature and soft tissue characteristics. Ultra-high frequency ultrasound is an adjunctive technology that is helpful in both the pre-operative and intra-operative setting for selection of anastomotic targets. Novel techniques such as contrast-enhanced ultrasound and photoacoustic imaging have promising applications to lymphatic surgery.Expert opinion: Imaging in lymphatic surgery continues to evolve, with novel technologies providing promise in advancing the field. Advances continue to improve access to imaging both in the clinic and operating room, helping to improve surgical techniques and success of lymphatic surgeries.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1065-1071"},"PeriodicalIF":2.7,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144983711","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Twelve-month clinical and radiographic outcomes following inferior-posterior sacroiliac joint fusion using the Catamaran SI Joint Fusion System: a prospective, multi-center evaluation. 双体体SI关节融合系统下-后路骶髂关节融合术后12个月的临床和影像学结果：一项前瞻性、多中心评估

IF 2.7

Expert review of medical devices Pub Date : 2025-10-01 Epub Date: 2025-08-19 DOI: 10.1080/17434440.2025.2544611

Matthew Davies, Anne Christopher, John Edwards, Roland Kent, Andrew Trobridge, Marcel Dreischarf, Rachelle Yusufbekov, Timothy Beacham

{"title":"Twelve-month clinical and radiographic outcomes following inferior-posterior sacroiliac joint fusion using the Catamaran SI Joint Fusion System: a prospective, multi-center evaluation.","authors":"Matthew Davies, Anne Christopher, John Edwards, Roland Kent, Andrew Trobridge, Marcel Dreischarf, Rachelle Yusufbekov, Timothy Beacham","doi":"10.1080/17434440.2025.2544611","DOIUrl":"10.1080/17434440.2025.2544611","url":null,"abstract":"Background: Scientific evidence on novel transarticular inferior-posterior surgical approaches for sacroiliac (SI) joint fusion, designed to minimize the risk of neurovascular injury, remains limited.Methods: This prospective, multi-center study evaluated disability (ODI), SI-joint pain (VAS), and patient satisfaction following SI joint fusion using the inferior-posterior approach. The primary endpoint was composite success, defined as: (1) ≥20 mm VAS pain reduction, (2) no device-related serious adverse events, (3) no neurological worsening, and (4) no surgical reintervention. Fusion was assessed at 12 months via independent radiographic CT review.Results: Thirty-six patients (mean age: 58.9 years; 77.8% female) underwent treatment. At the time of analysis, ODI significantly improved from 51.6% at baseline to 28.0% at 6-month (n = 32) and 20.8% at 12-month (n = 24, all p < 0.001). VAS scores declined from 78.8 mm to 35.6 mm at 6-month (n = 30) and 23.0 mm at 12-month (n = 24, all p < 0.001). Composite success was achieved in 73.3% at 6 month and 87.0% at 12 months (post hoc). Fusion was confirmed in 82.6% of cases, with 83.3% patient satisfaction. No serious device- or procedure-related adverse events or reinterventions were reported.Conclusion: This interim analysis of an ongoing study demonstrates significant improvements in disability and pain, while the novel surgical approach promotes fusion. Although the results are promising, larger studies with longer follow-up are warranted to validate these findings.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1117-1125"},"PeriodicalIF":2.7,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144801319","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Response to comment on 'Comparative validation of handheld fractional exhaled nitric oxide measurements'. 对“手持式分数呼气一氧化氮测量的比较验证”评论的回应。

IF 2.7

Expert review of medical devices Pub Date : 2025-10-01 Epub Date: 2025-08-11 DOI: 10.1080/17434440.2025.2546475

Sanne van Deelen, Gert-Jan Braunstahl

引用次数: 0

Biosensor-embedded wearables for dry eye monitoring and management. 用于干眼监测和管理的嵌入式生物传感器可穿戴设备。

IF 2.7

Expert review of medical devices Pub Date : 2025-10-01 Epub Date: 2025-09-01 DOI: 10.1080/17434440.2025.2555485

Bharat Gurnani, Kirandeep Kaur

{"title":"Biosensor-embedded wearables for dry eye monitoring and management.","authors":"Bharat Gurnani, Kirandeep Kaur","doi":"10.1080/17434440.2025.2555485","DOIUrl":"10.1080/17434440.2025.2555485","url":null,"abstract":"Introduction: Dry eye disease (DED) affects over 300 million people worldwide and continues to pose diagnostic challenges due to fluctuating symptoms and reliance on static, clinic-based tests. Conventional methods such as Schirmer's test and tear osmolarity provide only episodic insights, failing to capture the dynamic behavior of the tear film. Recently, biosensor-embedded wearable devices, including smart contact lenses, eyelid-mounted patches, and sensor-equipped spectacles, have emerged, enabling real-time and continuous tracking of tear metrics and blink patterns. These technologies promise precision diagnostics and patient-specific therapeutic strategies.Areas covered: This review summarizes recent advances in ocular biosensor wearables for DED. Key innovations include smart lenses with osmolarity and biomarker sensors, microfluidic channels for tear collection, and eyelid-mounted iontronic sensors for blink monitoring. Regulatory pathways such as FDA 510(k), ISO 10,993 safety standards, and HL7 FHIR for data integration are discussed. Early clinical studies support feasibility, though power supply, device miniaturization, and patient adherence remain obstacles. Ethical, economic, and privacy considerations are also highlighted.Expert opinion: Biosensor-based wearables are redefining DED care, offering precision diagnostics, early intervention, and long-term monitoring. Their success depends on clinical validation, affordability, patient comfort, and seamless integration with telehealth. Interdisciplinary collaboration will be crucial to transition these innovations into routine clinical practice.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1073-1079"},"PeriodicalIF":2.7,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144983549","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Device profile of Optilume BPH Catheter System for minimally invasive treatment of benign prostatic hyperplasia. 用于微创治疗良性前列腺增生的Optilume BPH导管系统设备简介。

IF 2.7

Expert review of medical devices Pub Date : 2025-10-01 Epub Date: 2025-09-01 DOI: 10.1080/17434440.2025.2553051

Mohammadali Saffarzadeh, Marcus Derigs, Runhan Ren, Naeem Bhojani, Dean Elterman, Connor M Forbes

{"title":"Device profile of Optilume BPH Catheter System for minimally invasive treatment of benign prostatic hyperplasia.","authors":"Mohammadali Saffarzadeh, Marcus Derigs, Runhan Ren, Naeem Bhojani, Dean Elterman, Connor M Forbes","doi":"10.1080/17434440.2025.2553051","DOIUrl":"10.1080/17434440.2025.2553051","url":null,"abstract":"Introduction: Benign Prostatic Hyperplasia (BPH) can lead to Lower Urinary Tract Symptoms (LUTS) that worsen with age and impact quality of life. Minimally invasive Surgical Therapies (MISTs) provide an alternative to medical and surgical interventions for the treatment of LUTS. The Optilume BPH Catheter System is a MIST for LUTS, which is the focus of this review.Areas covered: The Optilume BPH Catheter System is a Food and Drug Administration (FDA)-approved MIST that utilizes balloon dilation and delivery of paclitaxel to the prostatic urethra to treat LUTS. This review evaluates the technology, utility, clinical evidence, safety profile, and long-term efficacy of Optilume BPH Catheter System, in the context of alternative options for management of LUTS. PubMed and Google Scholar were searched and all published articles and abstracts up to May 2025 related to Optilume BPH Catheter Systems were included in our review.Expert opinion: The Optilume BPH Catheter System is a promising MIST in the market with durable results and acceptable safety profile. Ongoing and future research will further refine its long-term safety and efficacy.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1081-1091"},"PeriodicalIF":2.7,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144983626","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0