The evaluation of a novel single-lead biopotential device for home sleep testing.

Study Objectives: This paper reports on the clinical evaluation of the sleep staging performance of a novel single-lead biopotential device.

Methods: 133 patients suspected of obstructive sleep apnea were included in a multi-site cohort. All patients underwent polysomnography and received the study device, a single-lead biopotential measurement device attached to the forehead.

Feature importance for estimating rating of perceived exertion from cardiorespiratory signals using machine learning.

Introduction: The purpose of this study is to investigate the importance of respiratory features, relative to heart rate (HR), when estimating rating of perceived exertion (RPE) using machine learning models.

Methods: A total of 20 participants aged 18 to 43 were recruited to carry out Yo-Yo level-1 intermittent recovery tests, while wearing a COSMED K5 portable metabolic machine. RPE information was collected throughout the Yo-Yo test for each participant.

More than red tape: exploring complexity in medical device regulatory affairs.

Introduction: This study investigates the complexity of regulatory affairs in the medical device industry, a critical factor influencing market access and patient care.

Methods: Through qualitative research, we sought expert insights to understand the factors contributing to this complexity. The study involved semi-structured interviews with 28 professionals from medical device companies, specializing in various aspects of regulatory affairs.

Regulatory Frameworks for AI-Enabled Medical Device Software in China: Comparative Analysis and Review of Implications for Global Manufacturer.

The China State Council released the new generation artificial intelligence (AI) development plan, outlining China's ambitious aspiration to assume global leadership in AI by the year 2030. This initiative underscores the extensive applicability of AI across diverse domains, including manufacturing, law, and medicine. With China establishing itself as a major producer and consumer of medical devices, there has been a notable increase in software registrations.

Evaluating the Agreement between Oral, Armpit, and Ear Temperature Readings during Physical Activities in an Outdoor Setting.

Accurate body temperature measurement is essential for monitoring and managing safety during outdoor activities. Physical activities are an essential consideration for public health, with sports taking up an important proportion of these. Athletes' performances can be directly affected by body temperature fluctuations, with overheating or hypothermia posing serious health risks.

Clinician and parent views on urine collection in precontinent children in the UK: a qualitative interview study.

Objective: To explore the experiences of healthcare professionals (HCPs) and parents of urine collection methods, to identify barriers to successful sampling and what could improve the process.

Design: Qualitative research, using individual semistructured interviews with HCPs and parents. The interviews were audiorecorded, transcribed and thematically analysed.

A modular, deep learning-based holistic intent sensing system tested with Parkinson's disease patients and controls.

People living with mobility-limiting conditions such as Parkinson's disease can struggle to physically complete intended tasks. Intent-sensing technology can measure and even predict these intended tasks, such that assistive technology could help a user to safely complete them. In prior research, algorithmic systems have been proposed, developed and tested for measuring user intent through a Probabilistic Sensor Network, allowing multiple sensors to be dynamically combined in a modular fashion.

Non-Contact Infrared Thermometers and Thermal Scanners for Human Body Temperature Monitoring: A Systematic Review.

In recent years, non-contact infrared thermometers (NCITs) and infrared thermography (IRT) have gained prominence as convenient, non-invasive tools for human body temperature measurement. Despite their widespread adoption in a range of settings, there remain questions about their accuracy under varying conditions. This systematic review sought to critically evaluate the performance of NCITs and IRT in body temperature monitoring, synthesizing evidence from a total of 72 unique settings from 32 studies.

Evaluating the Potential of an Oral-Based Bioguard to Estimate Heart Rate Using Photoplethysmography.

The reliable monitoring of heart rate during intense exercise is imperative to effectively manage training loads while providing insights from a healthcare perspective. However, current technologies perform poorly in contact sports settings. This study aims to evaluate the best approach for heart rate tracking using photoplethysmography sensors embedded into an instrumented mouthguard (iMG).

Central Sleep Apnea Detection by Means of Finger Photoplethysmography.

Unlabelled: Obstructive Sleep Apnea (OSA) and Central Sleep Apnea (CSA) are two types of Sleep Apnea (SA) with different etiologies and treatment options. Home sleep apnea testing based on photoplethysmography-derived peripheral arterial tonometry (PAT HSAT) has become the most widely deployed outpatient SA diagnostic method. Being able to differentiate between CSA and OSA based solely on photoplethysmography-data would further increase PAT HSAT's clinical utility.

Performance of Oral Cavity Sensors: A Systematic Review.

Technological advancements are enabling new applications within biomedical engineering. As a connection point between the outer environment and the human system, the oral cavity offers unique opportunities for sensing technologies. This paper systematically reviews the performance of measurement systems tested in the human oral cavity.

Comparison of a Scaled Cadaver-Based Musculoskeletal Model With a Clinical Upper Extremity Model.

Reliably and accurately estimating joint/segmental kinematics from optical motion capture data has remained challenging. Studies objectively characterizing human movement patterns have typically involved inverse kinematics and inverse dynamics techniques. Subsequent research has included scaled cadaver-based musculoskeletal (MSK) modeling for noninvasively estimating joint and muscle loads.

Determining the performance of a temperature sensor embedded into a mouthguard.

Objective: This study aimed to determine the steady-state errors of oral-based temperature sensors, that are embedded in mouthguards, using a robust assessment process.

Materials And Methods: Four electronic boards with temperature sensors were encapsulated in mouthguards made from ethylene-vinyl acetate (EVA). The error and time to reach steady-state temperature were determined using a thermostatic water bath during three different conditions (34, 38.

A multicentric validation study of a novel home sleep apnea test based on peripheral arterial tonometry.

Study Objectives: This paper reports on the multicentric validation of a novel FDA-cleared home sleep apnea test based on peripheral arterial tonometry (PAT HSAT).

Methods: One hundred sixty-seven participants suspected of having obstructive sleep apnea (OSA) were included in a multicentric cohort. All patients underwent simultaneous polysomnography (PSG) and PAT HSAT, and all PSG data were independently double scored using both the recommended 1A rule for hypopnea, requiring a 3% desaturation or arousal (3% Rule), and the acceptable 1B rule for hypopnea, requiring a 4% desaturation (4% Rule).

Towards Dynamic Multi-Modal Intent Sensing Using Probabilistic Sensor Networks.

Intent sensing-the ability to sense what a user wants to happen-has many potential technological applications. Assistive medical devices, such as prosthetic limbs, could benefit from intent-based control systems, allowing for faster and more intuitive control. The accuracy of intent sensing could be improved by using multiple sensors sensing multiple environments.

Impact behaviour of 3D printed cellular structures for mouthguard applications.

Ethylene-Vinyl Acetate (EVA) is the most popular material for manufacturing mouthguards. However, EVA mouthguards are problematic, for example inconsistent thicknesses across the mouthguard. Additive manufacturing provides a promising solution to this problem, as it can manufacture mouthguards with a greater precision.

HeadSLAM: Pedestrian SLAM with Head-Mounted Sensors.

Research focused on human position tracking with wearable sensors has been developing rapidly in recent years, and it has shown great potential for application within healthcare, smart homes, sports, and emergency services. Pedestrian Dead Reckoning (PDR) with Inertial Measurement Units (IMUs) is one of the most promising solutions within this domain, as it does not rely on any additional infrastructure, whilst also being suitable for use in a diverse set of scenarios. However, PDR is only accurate for a limited period of time before unbounded errors, due to drift, affect the position estimate.

Tracking the Presence of Software as a Medical Device in US Food and Drug Administration Databases: Retrospective Data Analysis.

Background: Software as a medical device (SaMD) has gained the attention of medical device regulatory bodies as the prospects of standalone software for use in diagnositic and therapeutic settings have increased. However, to date, figures related to SaMD have not been made available by regulators, which limits the understanding of how prevalent these devices are and what actions should be taken to regulate them.

Objective: The aim of this study is to empirically evaluate the market approvals and clearances related to SaMD and identify adverse incidents related to these devices.

Correlations between home sleep apnea tests and polysomnography outcomes do not fully reflect the diagnostic accuracy of these tests.

Study Objectives: The clinical performance of home sleep apnea tests (HSATs) can be described by their (diagnostic) accuracy, defined as the percentage agreement with the obstructive sleep apnea severity category (normal, mild, moderate, and severe) based on polysomnography. Rather than reporting on accuracy, there has been a strong reliance in the literature to report correlation coefficients between the apnea-hypopnea index of HSATs and polysomnography to support claims of diagnostic performance. This is surprising, as it has been well described that correlation coefficients are inadequate to evaluate equivalence between 2 parameters.

Phenotyping REM OSA by means of peripheral arterial tone-based home sleep apnea testing and polysomnography: A critical assessment of the sensitivity and specificity of both methods.

The clinical relevance of rapid eye movement sleep-related obstructive sleep apnea (REM OSA) is supported by its associated adverse health outcomes and impact on optimal treatment strategies. To date, no assessment of REM OSA phenotyping performance has been conducted for any type of sleep testing technology. The objective of this study was to assess this for polysomnography and peripheral arterial tone-based home sleep apnea testing (PAT HSAT).

A Pedestrian Dead Reckoning Method for Head-Mounted Sensors.

Pedestrian dead reckoning (PDR) plays an important role in modern life, including localisation and navigation if a Global Positioning System (GPS) is not available. Most previous PDR methods adopted foot-mounted sensors. However, humans have evolved to keep the head steady in space when the body is moving in order to stabilise the visual field.

Comparing thermal discomfort with skin temperature response of lower-limb prosthesis users during exercise.

Background: Thermal discomfort is prevalent among prosthesis users. This observational study of thirty unilateral lower-limb prosthesis users compared their skin temperatures and the thermal discomfort experienced during exercise between their residual and contralateral limbs.

Methods: Participants performed a 2-minute interval cycling exercise test.

Mechanical Safety of Embedded Electronics for In-body Wearables: A Smart Mouthguard Study.

The growing popularity of contact sports drives the requirement for better design of protective equipment, such as mouthguards. Smart mouthguards with embedded electronics provide a multitude of new ways to provide increased safety and protection to users. Characterisation of how electronic components embedded in typical mouthguard material, ethylene vinyl acetate (EVA), behave under typical sports impacts is crucial for future designs.

Remote fitting procedures for upper limb 3d printed prostheses.

Background: The objective of the current investigation was twofold: i) describe a remote fitting procedure for upper limb 3D printed prostheses and ii) assess patient satisfaction and comfort with 3D printed prostheses fitted remotely.

Methods: A qualitative study using content and score analysis to describe patient satisfaction after remote prosthetic fitting. Research participants reported QUEST and OPUS scores that allow for perceived rating of general aspects and functionality of upper limb prostheses.

Clinical efficacy and effectiveness of 3D printing: a systematic review.

Objective: To evaluate the clinical efficacy and effectiveness of using 3D printing to develop medical devices across all medical fields.

Design: Systematic review compliant with Preferred Reporting Items for Systematic Reviews and Meta-Analyses.

Data Sources: PubMed, Web of Science, OVID, IEEE Xplore and Google Scholar.