ReviewFrontiers in bioengineering and biotechnology2019
Comprehensive Review on Current and Future Regulatory Requirements on Wearable Sensors in Preclinical and Clinical Testing.
Review in Frontiers in bioengineering and biotechnology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers, 5 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
32 citing papers in PubMed, 5 syntheses or guidelines pooled it, 76 citations in OpenAlex.
- The Use of Wearable Devices in Oncology Patients: A Systematic Review.The oncologist · 2024Pooled it
- The acceptability of using wearable electronic devices to monitor physical activity of patients with Multiple Myeloma undergoing treatment: a systematic review.Clinical hematology international · 2024Pooled it
- Recommendations for determining the validity of consumer wearable heart rate devices: expert statement and checklist of the INTERLIVE Network.British journal of sports medicine · 2021Guideline
- The Use of Wearables in Clinical Trials During Cancer Treatment: Systematic Review.JMIR mHealth and uHealth · 2020Pooled it
- Digital biomarkers for early agitation detection in dementia: a scoping review of emerging wearable and smart technologies for personalized care.Frontiers in neurologyPooled it
- From Static to Dynamic: The Convergence of Nanomaterials and 3D/4D Bioprinting for Adaptive Wearable Sports Biosensors.Biosensors · 2026Review
- Biopolymer-Based Electrospun Nanofibers for Wound Healing, Regeneration, and Therapeutics.Materials (Basel, Switzerland) · 2026Review
- Low-cost contact microphones for bedside voice assessment: proof of concept.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2026Article
- Patient-centered gastrointestinal function assessment technologies: a paradigm shift from traditional approaches to non-invasive innovations.Frontiers in physiology · 2026Review
- Stimulation Modalities in Wearable Haptic Systems: Single-Mode Feedback to Multiphysics Actuation.Research (Washington, D.C.) · 2026Review
- Clinical biomarkers and biosensors for early detection of metabolic dysfunction-associated steatohepatitis (MASH): a translational perspective.Frontiers in bioengineering and biotechnology · 2026Review
- Exhaled Aldehydes and Ketones as Biomarkers of Lung Cancer and Diabetes: Review of Sensor Technologies for Early Disease Diagnosis.Biosensors · 2025Review
- A Two-Dimensional Position and Motion Monitoring System for Preterm Infants Using a Fiber-Optic Pressure-Sensitive Mattress.Sensors (Basel, Switzerland) · 2025Article
- A novel strategy for controllable electrofabrication of molecularly imprinted polymer biosensors utilizing embedded Prussian blue nanoparticles.Scientific reports · 2025Article
- Gamification and its Potential for Better Engagement in the Management of Heart Failure or Quality of Care Registries: A Viewpoint.Current heart failure reports · 2024Review
- A scoping review on advancements in noninvasive wearable technology for heart failure management.NPJ digital medicine · 2024Article
- Tear-Based Ocular Wearable Biosensors for Human Health Monitoring.Biosensors · 2024Review
- Biomimetic Materials for Skin Tissue Regeneration and Electronic Skin.Biomimetics (Basel, Switzerland) · 2024Review
- Considering and understanding developmental and deployment barriers for wearable technologies in neurosciences.Frontiers in neuroscience · 2024Article
- Real-Time Monitoring of Antibiotics in the Critically Ill Using Biosensors.Antibiotics (Basel, Switzerland) · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Medical devices are designed, tested, and placed on the market in a highly regulated environment. Wearable sensors are crucial components of various medical devices: design and validation of wearable sensors, if managed according to international standards, can foster innovation while respecting regulatory requirements. The purpose of this paper is to review the upcoming European Union (EU) Medical Device Regulations 2017/745 and 2017/746, the current and future International Electrotechnical Commission (IEC) and International Organization for Standardization (ISO) standards that set methods for design and validation of medical devices, with a focus on wearable sensors. Risk classification according to the regulation is described. The international standards IEC 62304, IEC 60601, ISO 14971, and ISO 13485 are reviewed to define regulatory restrictions during design, pre-clinical validation and clinical validation of devices that include wearable sensors as crucial components. This paper is not about any specific innovation but it is a toolbox for interpreting current and future regulatory restrictions; an integrated method for design planning, validation and clinical testing is proposed. Application of this method to design wearable sensors should be evaluated in the future in order to assess its potentially positive impact to fostering innovation and to ensure timely development.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.