Advances and Challenges in Wearable Sensors for Health Monitoring

Clinical Snapshot

Key Findings

• P Value: Not reported at review level

• Effect Size: Not applicable — no pooled effect size reported; individual primary studies cited report widely variable sensor performance metrics (sensitivity, selectivity, limit of detection) specific to each analyte-device combination

• Primary Outcome: Narrative synthesis of the state of the art in wearable biosensor technologies for health monitoring, encompassing chemical sensors (sweat, saliva, tears, interstitial fluid, cerebrospinal fluid), physical sensors (heart rate, blood pressure, temperature), device formats, materials, energy systems, data analytics, and regulatory/ethical frameworks

• Nnt Or Sensitivity: Not applicable at review level; individual device sensitivity and specificity data cited from primary studies vary substantially by analyte, matrix, and device design — no summary diagnostic accuracy statistics are provided

• Confidence Interval: Not reported at review level

Clinical Application

Clinical translation remains limited for most technologies reviewed. Key barriers include: (1) insufficient clinical validation in diverse, real-world patient populations; (2) sensor drift, biofouling, and calibration challenges during extended wear; (3) lack of standardised regulatory pathways for novel sensor-biofluid combinations; (4) data security and interoperability with electronic health records; (5) cost and manufacturing scalability. Sweat-based glucose sensors and continuous glucose monitors (CGMs) are closest to clinical adoption, with CGMs already in widespread clinical use. Most other technologies remain at TRL 3–5. In Australia, continuous glucose monitors (e.g., Dexcom G6/G7, FreeStyle Libre) are TGA-registered and PBS-subsidised for eligible patients with type 1 diabetes under the National Diabetes Services Scheme (NDSS), representing the most clinically mature wearable biosensor category. The TGA regulates wearable health devices as medical devices under the Therapeutic Goods Act 1989, with classification dependent on intended use and risk level. The RACGP supports integration of digital health tools including wearables into chronic disease management but emphasises the need for clinical-grade validation. The My Health Record system provides a potential infrastructure for wearable-generated data integration, though interoperability standards remain underdeveloped. Australia's geographic diversity and significant rural and remote population make decentralised, wearable-based monitoring particularly relevant for closing healthcare access gaps. The Australian Digital Health Agency's National Digital Health Strategy 2023–2028 explicitly identifies wearable health technologies as a priority area. Regulatory and reimbursement pathways for novel wearable biosensors (beyond CGMs) remain undefined, representing a key translational barrier in the Australian context. Patients requiring continuous or frequent monitoring of physiological and biochemical parameters, including those with diabetes (glucose monitoring), cardiovascular disease (blood pressure, heart rate), metabolic disorders (electrolytes, lactate, uric acid), neurological conditions, and athletes or individuals in occupational health settings. Implantable sensor sections are relevant to patients with chronic conditions requiring long-term biomarker surveillance.

Abstract

Analytical tools may revolutionize healthcare by enabling accessible, rapid, and decentralized testing. Wearable (bio)sensors, in particular, provide frequent or continuous patient monitoring through non- to minimally invasive measurements. This approach yields unprecedented amounts of health-related information, leading to more informed clinical decision-making and closer patient follow-up. In this mega-review article, we bring together leading researchers in the field to discuss the state of the art in wearable devices for health monitoring. We begin by providing a broad overview of the field through citation network analysis. We then review the application of chemical (bio)sensors in biofluids (e.g., sweat, saliva, tears, interstitial fluid, and cerebrospinal fluid), highlighting the challenges and advantages associated with each. Subsequently, we discuss the construction of wearable devices and their main formats (e.g., smart contact lenses, textiles, mouthguards, watches/wristbands, and implantable systems). Physical sensors are addressed in a dedicated section focusing on the assessment of heart rate, blood pressure, and body temperature. The role of soft electronics in wearable devices is also examined, as these technologies are essential for enhancing user comfort and sensor reliability, which demands advances in materials science. Furthermore, we present strategies for signal acquisition and transmission, as well as approaches for on-body energy harvesting and device self-powering. The use of artificial intelligence and machine learning is then discussed as a means of enhancing analytical performance and managing the large volumes of data generated by wearable devices. Finally, business, regulatory, and ethical considerations are examined. We expect that this review will provide an overview of sensing and biosensing technologies for health-related applications, identify promising research directions, and inspire future developments.

References

1. 1.Brazaca, L. C., Moreno Lozano, A., Mayol, B., Scheidt, D. T., De Fazio, D., Kim, E., Maroli, G., Rosati, G., Ates, H. C., Wang, H., Kim, H. J., Ha, J.-H., Yang, J., Jeon, J., Goldhahn, J., Sonigara, K. K., Li, L., Zhou, M., Cho, S., Fan, S., Wu, S., Gonçalves, V. M., Dei Santi, V. H. B., Zhou, W., Heng, W., Chung, W. G., Li, X., Zou, Y., Jin, Y., Wu, Z., Bandodkar, A. J., Merkoçi, A., Dincer, C., Lim, C. T., Kim, D.-H., Carrilho, E., Salvatore, G. A., Shen, G., Park, I., Jeerapan, I., Park, J.-U., Wu, J., Ho, J. S., Rogers, J., Wang, J., Plaxco, K. W., Ferreira de Oliveira, M. C., Pumera, M., Brasier, N., Veiseh, O., Lee, P. S., Tsukruk, V. V., Gao, W., Zhu, Y., Wang, Z. L., Li, Z., Sempionatto, J., & Oliveira, O. N. (2026). Advances and challenges in wearable sensors for health monitoring. ACS Applied Materials & Interfaces. Advance online publication. https://doi.org/10.1021/acsami.6c04520