Expert review of medical devices最新文献

Introduction: With the increasing requirements for performance and safety of lower limb exoskeleton rehabilitation robots, researchers are exploring various active compliance control strategies to improve the compliance of control and enhance safety and effectiveness of rehabilitation training. The focus of this paper is to evaluate existing active compliance control strategies applied to lower limb exoskeleton rehabilitation robots, highlighting their principles, key technologies, and performance.

Areas covered: Literature searches were conducted in PubMed and Web of Science from 2000 to 2025, starting with the broad keyword 'active compliance control strategy' and narrowing down to specific aspects such as 'impedance control'. Sixty-nine articles were reviewed, and eight active compliance control strategies were divided into three categories according to their core principles: impedance control (n = 18), force, and position hybrid control (n = 27) and machine learning-based hybrid control (n = 24). Their applications in five types of lower limb exoskeleton rehabilitation robots are outlined.

Expert opinion: Active compliance control strategies for lower limb exoskeleton rehabilitation robots are necessary for safe human-robot interaction and assist-as-needed implementation. This paper envisions the concept of an active compliance controller that covers the entire rehabilitation cycle, ensuring that the robot is continuously aligned with the patient's rehabilitation needs.

Introduction: Leprosy remains a major public health challenge in countries like India, Brazil, and Indonesia. The materiovigilance program was established to monitor the safety of medical devices and helps to protect health-care workers and patients from device-related injuries. Leprosy patients suffer from sensory loss and are at high risk of developing injuries with medical devices. Therefore, integrating materiovigilance program with the national leprosy care program is essential to improve the safety and wellbeing of leprosy patients.

Areas covered: This critical perspective covers the role of materiovigilance in India, the classification of medical devices based on their risk status, devices used in leprosy management, the Indian and international target goals for leprosy elimination, and emphasis on the integration of materiovigilance programs with leprosy programs in leprosy treating hospitals.

Expert opinion: There is a significant gap existing in the leprosy elimination policies regarding the safety concerns with the use of medical devices. Successful integration of materiovigilance framework with leprosy elimination policies will influence the treatment outcomes in a positive manner. The key challenges to overcome are lack of awareness, training, and funding. Implementing the integration strategy in a stage-wise manner will help to identify the lacunae, operational issues, and further strengthen the program.

Introduction: Generalized tonic - clonic seizures (GTCS) is a major cause of sudden unexpected death in epilepsy (SUDEP); thus, continuous monitoring is essential. Electroencephalography (EEG) is the diagnostic gold standard; however, non-EEG wearables have emerged as promising, user-friendly alternatives enhancing comfort, mobility, and social acceptance.

Areas covered: This scoping review compared sensing modalities and computational methods used for seizure detection and prediction, identified effective sensor combinations, and highlighted current research gaps. Following PRISMA-ScR guidelines, Scopus, IEEE Xplore, and PubMed databases were searched up to 22 April 2025. Twenty-nine studies met inclusion criteria. For seizure detection, combining electrodermal activity (EDA) with motion sensors - accelerometers (ACC) and gyroscopes (GYR) - and surface electromyography (sEMG) achieved high reliability, 98.6% precision, while using ACC and EDA alone yielded superior sensitivities up to 97.2% and a lower false alarm rate (FAR) of 0.53/24 h. Regarding seizure prediction, combining EDA, blood volume pulse (BVP), ACC, and temperature showed the highest sensitivity of 75.6%.

Expert opinion: Wearable multimodal non-EEG seizure detection and prediction systems offer personalized care but face validation, hardware, and privacy hurdles. Future success depends on efficient AI, IoT integration, patient-centric design, and clear regulations ensuring accessible and trustworthy clinical tools.

Introduction: Sacroiliac joint (SIJ) dysfunction accounts for up to 30% of axial low back pain and is increasingly managed surgically after failure of conservative care. While traditional open SIJ fusion carried significant morbidity, minimally invasive (MIS) approaches have transformed outcomes. More recently, stereotactic navigation and robotic assistance have emerged to enhance implant placement accuracy and reduce radiation exposure.

Areas covered: We conducted a narrative review of the literature (PubMed, EMBASE, Cochrane Reviews, inception) on SIJ fusion techniques, implant accuracy, complications, fusion rates, and patient-reported outcomes. MIS SIJ fusion now predominates over open approaches, with lateral and posterior techniques both achieving >90% fusion at 12-18 months. Navigation and robotic systems achieve 92-98% implant accuracy (vs. 76-87% with fluoroscopy) and reduce intraoperative radiation exposure by up to 85%, especially in anatomically complex or revision cases.

Expert opinion: Navigated and robotic-assisted SIJ fusion represents significant technical progress. While short-term clinical outcomes remain comparable to fluoroscopic MIS fusion, navigation, and robotics improve safety, reproducibility, and radiation safety. Future multicenter trials should assess long-term outcomes, cost-effectiveness, and integration of augmented reality, AI, and novel implants to define their optimal role in sacroiliac joint surgery.

Introduction: Hypertension is a major global health burden and a leading contributor to cardiovascular morbidity and mortality. Recent advances in digital technology - including home blood pressure (BP), telemonitoring, mobile health applications, wearable devices, and clinical decision support systems - have opened new avenues for improving hypertension management by addressing limitations such as clinical inertia, poor medication adherence, and lack of individualized care. These tools support patient engagement, facilitate behavioral change, and enable remote treatment optimization.

Areas covered: This review summarizes the current evidence supporting digital interventions for BP control, highlighting findings from recent randomized controlled trials and meta-analyses via PubMed (2000-2025). Evidence indicates that digital strategies have demonstrated significant reductions in systolic BP compared with usual care, with benefits observed across diverse populations and settings. Digital health approaches have also been shown to enhance medication adherence, promote lifestyle modifications, and offer cost-effective alternatives to conventional care. Moreover, their utility during disasters and pandemics underscores their value in ensuring continuity of care.

Expert opinion: While challenges remain, including integration into clinical workflows, regulatory considerations, and disparities in access - efforts to validate, standardize, and scale digital solutions will be critical to their successful implementation in routine care.

Introduction: Obstructive sleep apnea (OSA) is a prevalent sleep disorder associated with serious health consequences and major economic burdens. Current diagnosis and treatment approaches are insufficient for the growing global burden of OSA. Novel device-led technologies may enable more efficient and personalized OSA management.

Areas covered: This review explores the potential role of screening tools such as regulatory-cleared wearables and discusses recent advancements in simplified home sleep testing and automated scoring software. Current and emerging OSA treatment monitoring systems, treatment optimization approaches, and therapy guidance tools are explored. Finally, we highlight the role of cloud-based platforms, telehealth, and AI-driven applications in enabling long-term monitoring and precision medicine approaches.

Expert opinion: Novel OSA-related devices are enhancing clinical practice by improving access, adherence, and therapy outcomes. Patients and clinicians are encouraged to embrace the technology with caution. Challenges remain in the accuracy of diagnostic and treatment devices, ensuring data privacy, and integrating these tools into clinical practice. Regulatory bodies must advocate for independent clinical trial validation standards, algorithmic transparency, and education on novel devices for patients and clinicians, to ensure safe implementation. With continued innovation, validation, and adoption, device-led care may become central to the proactive and patient-centered future of OSA management.