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Science Advances Apr 2024Miniaturized neuromodulation systems could improve the safety and reduce the invasiveness of bioelectronic neuromodulation. However, as implantable bioelectronic devices...
Miniaturized neuromodulation systems could improve the safety and reduce the invasiveness of bioelectronic neuromodulation. However, as implantable bioelectronic devices are made smaller, it becomes difficult to store enough power for long-term operation in batteries. Here, we present a battery-free epidural cortical stimulator that is only 9 millimeters in width yet can safely receive enough wireless power using magnetoelectric antennas to deliver 14.5-volt stimulation bursts, which enables it to stimulate cortical activity on-demand through the dura. The device has digitally programmable stimulation output and centimeter-scale alignment tolerances when powered by an external transmitter. We demonstrate that this device has enough power and reliability for real-world operation by showing acute motor cortex activation in human patients and reliable chronic motor cortex activation for 30 days in a porcine model. This platform opens the possibility of simple surgical procedures for precise neuromodulation.
Topics: Humans; Animals; Swine; Reproducibility of Results; Electric Power Supplies; Motor Cortex
PubMed: 38608028
DOI: 10.1126/sciadv.adn0858 -
Digital Health 2024The significance of big data is increasingly acknowledged across all sectors, including medicine. Moreover, the trend of data trading is on the rise, particularly in...
OBJECTIVE
The significance of big data is increasingly acknowledged across all sectors, including medicine. Moreover, the trend of data trading is on the rise, particularly in exchanging other data for medical data to rejuvenate the medical industry. This study aimed to discern the facilitating factors of healthcare data trade.
METHODS
We assessed five medical data market platforms on October, 2022, based on three criteria: (a) clarity in articulating the data for sale; (b) transparency in specifying the data costs; and (c) explicit indication that payment grants data access. This helped identify the traded medical data types. Additionally, we anonymously surveyed 43 representatives from medical device companies about their demand for medical data trading, achieving a response rate of 66%.
RESULTS
Of the medical data traded on these platforms, 93.34% was structured, while 5.66% was unstructured, indicating an imbalance. Although there was a higher demand for structured medical data, there was also interest in purchasing unstructured medical data.
CONCLUSION
Unstructured big data are crucial for medical device development, fueling the demand for trading such data. Many stakeholders view the data market as essential and are willing to procure medical data. Consequently, medical device companies will need methods to acquire unstructured medical data for developing innovative and enhanced medical devices.
PubMed: 38832103
DOI: 10.1177/20552076241259871 -
Medical Review (2021) Oct 2023Medical device technology develops rapidly, and the life cycle of a medical device is much shorter than drugs. It is necessary to evaluate the safety and effectiveness...
Medical device technology develops rapidly, and the life cycle of a medical device is much shorter than drugs. It is necessary to evaluate the safety and effectiveness of a medical device in a timely manner to keep up with technology flux. Bayesian methods provides an efficient approach to addressing this challenge. In this article, we review the characteristics of the Bayesian approach and some Bayesian designs that were commonly used in medical device regulatory setting, including Bayesian adaptive design, Bayesian diagnostic design, Bayesian multiregional design, and Bayesian label expansion study. We illustrate these designs with medical devices approved by the US Food and Drug Administration (FDA). We also review several innovative Bayesian information borrowing methods, and briefly discuss the challenges and future directions of the Bayesian application in medical device trials. Our objective is to promote the use of the Bayesian approach to accelerate the development of innovative medical devices and their accessibility to patients for effective disease diagnoses and treatments.
PubMed: 38283256
DOI: 10.1515/mr-2023-0026 -
Scientific Reports Sep 2023The COVID-19 pandemic and discovery of new mutant strains have a devastating impact worldwide. Patients with severe COVID-19 require various equipment, such as...
The COVID-19 pandemic and discovery of new mutant strains have a devastating impact worldwide. Patients with severe COVID-19 require various equipment, such as ventilators, infusion pumps, and patient monitors, and a dedicated medical team to operate and monitor the equipment in isolated intensive care units (ICUs). Medical staff must wear personal protective equipment to reduce the risk of infection. This study proposes a tele-monitoring system for isolation ICUs to assist in the monitoring of COVID-19 patients. The tele-monitoring system consists of three parts: medical-device panel image processing, transmission, and tele-monitoring. This system can monitor the ventilator screen with obstacles, receive and store data, and provide real-time monitoring and data analysis. The proposed tele-monitoring system is compared with previous studies, and the image combination algorithm for reconstruction is evaluated using structural similarity index (SSIM) and peak signal-to-noise ratio (PSNR). The system achieves an SSIM score of 0.948 in the left side and a PSNR of 23.414 dB in the right side with no obstacles. It also reduces blind spots, with an SSIM score of 0.901 and a PSNR score of 18.13 dB. The proposed tele-monitoring system is compatible with both wired and wireless communication, making it accessible in various situations. It uses camera and performs live data monitoring, and the two monitoring systems complement each other. The system also includes a comprehensive database and an analysis tool, allowing medical staff to collect and analyze data on ventilator use, providing them a quick, at-a-glance view of the patient's condition. With the implementation of this system, patient outcomes may be improved and the burden on medical professionals may be reduced during the COVID-19 pandemic-like situations.
Topics: Humans; Pandemics; COVID-19; Ventilators, Mechanical; Intensive Care Units; Critical Care
PubMed: 37709819
DOI: 10.1038/s41598-023-42229-4 -
Sensors (Basel, Switzerland) Aug 2023Smart wearable devices enable personalized at-home healthcare by unobtrusively collecting patient health data and facilitating the development of intelligent platforms... (Review)
Review
Smart wearable devices enable personalized at-home healthcare by unobtrusively collecting patient health data and facilitating the development of intelligent platforms to support patient care and management. The accurate analysis of data obtained from wearable devices is crucial for interpreting and contextualizing health data and facilitating the reliable diagnosis and management of critical and chronic diseases. The combination of edge computing and artificial intelligence has provided real-time, time-critical, and privacy-preserving data analysis solutions. However, based on the envisioned service, evaluating the additive value of edge intelligence to the overall architecture is essential before implementation. This article aims to comprehensively analyze the current state of the art on smart health infrastructures implementing wearable and AI technologies at the far edge to support patients with chronic heart failure (CHF). In particular, we highlight the contribution of edge intelligence in supporting the integration of wearable devices into IoT-aware technology infrastructures that provide services for patient diagnosis and management. We also offer an in-depth analysis of open challenges and provide potential solutions to facilitate the integration of wearable devices with edge AI solutions to provide innovative technological infrastructures and interactive services for patients and doctors.
Topics: Humans; Artificial Intelligence; Awareness; Chronic Disease; Heart Failure; Wearable Electronic Devices
PubMed: 37571678
DOI: 10.3390/s23156896 -
Injury Oct 2023In May 2021, the new Medical Device Regulation in the EU came into force. While the US has a centralized governmental authority, the Food and Drug Administration (FDA),...
In May 2021, the new Medical Device Regulation in the EU came into force. While the US has a centralized governmental authority, the Food and Drug Administration (FDA), the EU implemented a system of different Notified Bodies responsible for the approval process of medical devices. Both regions have a similar system to classify medical devices based on their overall risks but specific devices, like joint prostheses, are classified differently in the US and the EU. Depending on the risk class, there are differences in the quality and quantity of clinical data required to obtain market approval. In both regions, it is possible to place a new device on the market based on the demonstration of equivalence to an already marketed device, but the MDR significantly increased the regulatory requirements for the equivalence pathway. While an approved medical device in the US in most cases only requires general post-market surveillance activities, manufacturers in the EU must continuously collect clinical data and submit specific reports to the Notified Bodies. In this article, we will compare the regulatory requirements between the US and Europe and provide an overview of similarities and differences.
Topics: United States; Humans; Europe; United States Food and Drug Administration; Medical Device Legislation
PubMed: 37365092
DOI: 10.1016/j.injury.2023.110908 -
Clinical Cardiology Oct 2023The management of chronic heart failure over the past decade has witnessed tremendous strides in medical optimization and device therapy including the use of left... (Review)
Review
The management of chronic heart failure over the past decade has witnessed tremendous strides in medical optimization and device therapy including the use of left ventricular assist devices (LVAD). What we once thought of as irreversible damage to the myocardium is now demonstrating signs of reverse remodeling and recovery. Myocardial recovery on the structural, molecular, and hemodynamic level is necessary for sufficient recovery to withstand explant and achieve sustained recovery post-LVAD. Guideline-directed medical therapy and unloading have been shown to aid in recovery with the potential to successfully explant the LVAD. This review will summarize medical optimization, assessment for recovery, explant methodologies and outcomes post-recovery with explant of durable LVAD.
Topics: Humans; Heart-Assist Devices; Heart Ventricles; Ventricular Remodeling; Heart Failure; Myocardium
PubMed: 37526373
DOI: 10.1002/clc.24094 -
Nature Communications Aug 2023Timely and remote biomarker detection is highly desired in personalized medicine and health protection but presents great challenges in the devices reported so far....
Timely and remote biomarker detection is highly desired in personalized medicine and health protection but presents great challenges in the devices reported so far. Here, we present a cost-effective, flexible and self-powered sensing device for HS biomarker analysis in various application scenarios based on the structure of galvanic cells. The sensing mechanism is attributed to the change in electrode potential resulting from the chemical adsorption of gas molecules on the electrode surfaces. Intrinsically stretchable organohydrogels are used as solid-state electrolytes to enable stable and long-term operation of devices under stretching deformation or in various environments. The resulting open-circuit sensing device exhibits high sensitivity, low detection limit, and excellent selectivity for HS. Its application in the non-invasive halitosis diagnosis and identification of meat spoilage is demonstrated, emerging great commercial value in portable medical electronics and food security. A wireless sensory system has also been developed for remote HS monitoring with the participation of Bluetooth and cloud technologies. This work breaks through the shortcomings in the traditional chemiresistive sensors, offering a direction and theoretical foundation for designing wearable sensors catering to other stimulus detection requirements.
Topics: Adsorption; Biomarkers; Electrodes; Electronics, Medical; Meat
PubMed: 37633989
DOI: 10.1038/s41467-023-40953-z -
International Journal of Computer... Sep 2023A robotic assistive device is developed for needle-based percutaneous interventions. The aim is a hybrid system using both manual and actuated robotic operation in order...
PURPOSE
A robotic assistive device is developed for needle-based percutaneous interventions. The aim is a hybrid system using both manual and actuated robotic operation in order to obtain a device that has a large workspace but can still fit in the gantry opening of a CT scanner. This will enable physicians to perform precise and time-efficient CT-guided percutaneous interventions. The concept of the mechanics and software of the device is presented in this work.
METHODS
The approach is a semi-automated robotic assistive device, which combines manual and robotic positioning to reduce the number and size of necessary motors. The system consists of a manual rough positioning unit, a robotic fine positioning unit and an optical needle tracking unit. The resulting system has eight degrees of freedom, of which four are manual, which comprise encoders to monitor the position of each axis. The remaining four axes are actuated axes for fine positioning of the needle. Cameras are attached to the mechanical structure for 3D tracking of the needle pose. The software is based on open-source software, mainly ROS2 as robotic middleware, Moveit2 for trajectory calculation and 3D Slicer for needle path planning.
RESULTS
The communication between the components was successfully tested with a clinical CT scanner. In a first experiment, four needle insertions were planned and the deviation of the actual needle path from the planned path was measured. The mean deviation from the needle path to the target point was 21.9 mm, which is mainly caused both by translational deviation (15.4 mm) and angular deviation (6.8°) of the needle holder. The optical tracking system was able to detect the needle position with a mean deviation of 3.9 mm.
CONCLUSION
The first validation of the system was successful which proves that the proposed concept for both the hardware and software is feasible. In a next step, an automatic position correction based on the optical tracking system will be integrated, which is expected to significantly improve the system accuracy.
Topics: Humans; Robotic Surgical Procedures; Tomography, X-Ray Computed; Robotics; Needles; Software; Phantoms, Imaging
PubMed: 37058232
DOI: 10.1007/s11548-023-02882-6 -
EuroIntervention : Journal of EuroPCR... Jul 2023A small aortic annulus (SAA) is a risk factor for prosthesis-patient mismatch (PPM) in patients undergoing surgical or transcatheter aortic valve implantation (TAVI)....
BACKGROUND
A small aortic annulus (SAA) is a risk factor for prosthesis-patient mismatch (PPM) in patients undergoing surgical or transcatheter aortic valve implantation (TAVI). Data regarding TAVI in patients with extra-SAA are scarce.
AIMS
The aim of this study was to analyse the safety and efficacy of TAVI in patients with extra-SAA.
METHODS
A multicentre registry study including patients with extra-SAA (defined as an aortic annulus area <280 mm and/or perimeter <60 mm) undergoing TAVI was established. Primary efficacy and safety endpoints were defined as device success and early safety at 30 days, respectively, using the Valve Academic Research Consortium-3 criteria, and were analysed according to valve type: self-expanding (SEV) versus balloon-expandable (BEV).
RESULTS
A total of 150 patients were included, of which 139 (92.7%) were women, and 110 (73.3%) received an SEV. Intraprocedural technical success was 91.3%, with a higher rate in patients receiving an SEV (96.4% vs 77.5% with BEV; p=0.001). Overall, 30-day device success was 81.3%, (85.5% with SEV vs 70.0% with BEV; p=0.032). The primary safety endpoint occurred in 72.0% of patients (with no difference between groups; p=0.118). Severe PPM occurred in 12% (9.0% with SEV and 24.0% with BEV; p=0.039), with no impact on all-cause mortality, cardiovascular mortality, or heart failure readmission at 2-year follow-up.
CONCLUSIONS
TAVI is a safe and feasible treatment in patients with extra-SAA with a high rate of technical success. The use of SEV was associated with a lower rate of intraprocedural complications, higher device success at 30 days and better haemodynamic outcomes compared to BEV.
Topics: Humans; Female; Male; Transcatheter Aortic Valve Replacement; Aortic Valve; Aortic Valve Stenosis; Prosthesis Design; Risk Factors; Heart Valve Prosthesis; Treatment Outcome
PubMed: 37334654
DOI: 10.4244/EIJ-D-23-00011