Innovative medical devices

BACKGROUND: Parkinson's disease (PD) is a progressive, neurodegenerative illness marked by the loss of dopaminergic neurons, causing motor symptoms. Oral levodopa replacement therapy remains the gold standard in the treatment of PD. It is, nevertheless, a symptomatic treatment. There is currently no effective treatment for PD. Therefore, new therapies for PD are highly desirable. Low-intensity pulsed ultrasound (LIPUS) has been shown to improve behavioral functions in PD animal models...

BACKGROUND: This industry survey was conducted to gain insight into the ways structured Benefit-Risk assessment (sBRA) of medical products is approached across drug or medical device developing companies, including frameworks and methods that are currently used and areas where future work is being planned. METHODS: A survey containing 28 questions covering five key areas of sBRA was set-up and shared with representatives from the participating companies. Each company was asked to complete a single survey response including inputs across the company's multidisciplinary key representatives involved in benefit-risk assessment...

This review article focuses on the recent printing technological progress in healthcare, underscoring the significant potential of implantable devices across diverse applications. Printing technologies have widespread use in developing health monitoring devices, diagnostic systems, and surgical devices. Recent years have witnessed remarkable progress in fabricating low-profile implantable devices, driven by advancements in printing technologies and nanomaterials. The importance of implantable biosensors and bioelectronics is highlighted, specifically exploring printing tools using bio-printable inks for practical applications, including a detailed examination of fabrication processes and essential parameters...

OBJECTIVES: Clinical trials of innovative neural implants are rapidly increasing and diversifying, but little is known about participants' post-trial access to the device and ongoing clinical care. This exploratory study examines common practices in the planning and coordination of post-trial access to neurosurgical devices. We also explore the perspectives of trial investigators on the barriers to post-trial access and ongoing care, as well as ethical questions related to the responsibilities of key stakeholder groups...

Several diseases affect the alveoli, and the efficacy of medical treatments and pharmaceutical therapies is hampered by the lack of pre-clinical models able to recreate in vitro the diseases. Microfluidic devices, mimicking the key structural and compositional features of the alveoli, offer several advantages to medium and high-throughput analysis of new candidate therapies. Here, we developed an alveolus-on-a-chip recapitulating the microanatomy of the physiological tissue by including the epithelium, the fibrous interstitial layer and the capillary endothelium...

We summarized the experience of surgical stabilization of rib fractures (SSRF) at a core hospital in eastern Hiroshima, which is a primary center for tertiary emergency medical care, especially for high-energy trauma cases including chest injuries. The study focuses on patients who underwent SSRF from January 2016 to September 2023, analyzing patient characteristics, injury mechanisms, associated injuries, fracture locations, time from injury to surgery, fixation devices used, and postoperative outcomes. Our hospital primarily treats elderly patients, and falls are the most common cause of injury, followed by traffic accidents...

Cardiovascular disease (CVD) remains a foremost global health concern, necessitating ongoing exploration of innovative therapeutic strategies. This review surveys the latest developments in cardiovascular therapeutics, offering a comprehensive overview of emerging approaches poised to transform disease management. The examination begins by elucidating the current epidemiological landscape of CVD and the economic challenges it poses to healthcare systems. It proceeds to scrutinize the limitations of traditional therapies, emphasizing the need for progressive interventions...

Accurate and efficient motion estimation is a crucial component of real-time ultrasound elastography (USE). However, obtaining radiofrequency ultrasound (RF) data in clinical practice can be challenging. In contrast, although B-mode (BM) data is readily available, elastographic data derived from BM data results in sub-optimal elastographic images. Furthermore, existing conventional ultrasound devices (e.g., portable devices) cannot provide elastography modes, which has become a significant obstacle to the widespread use of traditional ultrasound devices...

OBJECTIVE: The Open Payments Program (OPP) was a database started in 2013 by the US government to report payments made by the medical device and pharmaceutical industry to physicians. Neurosurgery is a technologically advanced field that relies heavily on the latest innovations for complex treatment of its patient population. This study sought to explore the financial relationship between academic neurosurgeons and the industry. METHODS: OPP data were reviewed for the year 2021 of all faculty neurosurgeons affiliated with a neurosurgery residency program...

Biofilms are an intricate community of microbes that colonize solid surfaces, communicating via a quorum-sensing mechanism. These microbial aggregates secrete exopolysaccharides facilitating adhesion and conferring resistance to drugs and antimicrobial agents. The escalating global concern over biofilm-related infections on medical devices underscores the severe threat to human health. Carbon dots (CDs) have emerged as a promising substrate to combat microbes and disrupt biofilm matrices. Their numerous advantages such as facile surface functionalization and specific antimicrobial properties, position them as innovative anti-biofilm agents...

The classification of medical devices by the Food and Drug Administration (FDA) involves rigorous scrutiny from specialized panels that designate devices as Class I, II, or III depending on their levels of relative risk to patient health. Posterior rigid pedicle screw systems were first classified by the FDA in 1984 and have since revolutionized the treatment of many spine pathologies. Despite this early classification by the FDA, posterior cervical pedicle and lateral mass screws were not reclassified from unclassified to Class III and then to Class II until 2019, nearly 35 years after their initial classification...

"Ningbo oriental acupuncture-moxibustion society" was founded in 1930 by ZHANG Junyi . At that era, the enrollment conditions were flexible, the disciplines of warm moxibustion and acupuncture-moxibustion were set and taught by means of face-to-face class and correspondence one. The teaching content included the knowledge of western learning and traditional theory of acupuncture-moxibustion. The Society issued two periodicals, Medical Newspaper of Warm Moxibustion and Oriental Acupuncture and Moxibustion , the staffs of the Society compiled teaching materials such as Warm Moxibustion and Advanced Acupuncture - Moxibustion , translated relevant books and improved the device and herbal medicine of warm moxibustion...

Sustainability of a medical device has not yet become a major issue in public discussions compared to other topics with impact to material performance, clinical application, production economy and environmental pollution. Due to their unique properties, polymers (plastics) allow for multiple, flexible applications in medical device technology. Polymers are part of the majority of disposable and single use medical device and contribute with 3% to the worldwide production of plastics. The global medical polymer market size was valued 19...

Background : Innovative methods of physical therapy delivered via modern medical devices have significantly extended the possibility of applying conservative treatments in healing venous leg ulcers. The primary objective of this study was to compare the therapeutic efficacy of selected mechanical physical therapies (intermittent pneumatic compression vs. radial extracorporeal shockwave vs. focal extracorporeal shockwave) vs. standard care in the treatment of venous leg ulcers over a 4-week period. Materials : This study included 69 patients, comprising 45 females (65%) and 24 males (35%), with a mean age of 67...

Electronic nose devices stand out as pioneering innovations in contemporary technological research, addressing the arduous challenge of replicating the complex sense of smell found in humans. Currently, sensor instruments find application in a variety of fields, including environmental, (bio)medical, food, pharmaceutical, and materials production. Particularly the latter, has seen a significant increase in the adoption of technological tools to assess food quality, gradually supplanting human panelists and thus reshaping the entire quality control paradigm in the sector...

The present work proposes a comprehensive metaheuristic methodology for the development of a medical robot for the upper limb rehabilitation, which includes the topological optimization of the device, kinematic models (5 DOF), human-robot interface, control and experimental tests. This methodology applies two cutting-edge triads: (1) the three points of view in engineering design (client, designer and community) and (2) the triad formed by three pillars of Industry 4.0 (autonomous machines and systems, additive manufacturing and simulation of virtual environments)...

The build-up of lactate in solid tumors stands as a crucial and early occurrence in malignancy development, and the concentration of lactate in the tumor microenvironment may be a more sensitive indicator for analyzing primary tumors. In this study, we designed a self-powered lactate sensor for the rapid analysis of tumor samples, utilizing the coupling between the piezoelectric effect and enzymatic reaction. This lactate sensor is fabricated using a ZnO nanowire array modified with lactate oxidase (LOx). The sensing process does not require an external power source or batteries...

Opioid administration is particularly challenging in the perioperative period. Computerized-based Clinical Decision Support Systems (CDSS) are a promising innovation that might improve perioperative pain control. We report the development and feasibility validation of a knowledge-based CDSS aiming at optimizing the management of perioperative pain, postoperative nausea and vomiting (PONV), and laxative medications. This novel CDSS uses patient adaptive testing through a smartphone display, literature-based rules, and individual medical prescriptions to produce direct medical advice for the patient user...

Smart GxP inspections have gained increasing attention due to the COVID-19 pandemic, which, understandably, made it challenging for regulatory authorities to conduct on-site inspections. Smart GxP inspections are an oversight approach developed by the SFDA to enable remote compliance assessments of establishments. In this type of inspection, appropriate technical methods and tools (such as livestreaming video) are used without requiring the presence of inspectors onsite, ensuring efficient utilization of resources and the efficiency of inspection process...

BACKGROUND: With the rapid shift to telehealth, there remains a knowledge gap in how video-based care is implemented in interdisciplinary primary care (PC) settings. OBJECTIVE: The objective of this study was to gain an in-depth understanding of how video telehealth services were implemented in PC from the perspectives of patients and interdisciplinary PC team members at the Veterans Health Administration (VHA) 2 years after the onset of the COVID-19 pandemic. METHODS: We applied a positive and negative deviance approach and selected the 6% highest (n=8) and the 6% lowest (n=8) video-using PC sites in 2022 from a total of 130 VHA medical centers nationally...