Flexible Wearable Closed-Loop Diagnostic and Therapeutic System: A New Paradigm for Skin Health Management

Clinical Snapshot

Key Findings

• P Value: Not reported at the review level — no statistical testing is performed.

• Effect Size: Not applicable — no pooled effect size is reported. Individual device performance metrics cited within the review are not synthesised quantitatively.

• Primary Outcome: No primary clinical outcome is formally defined or quantitatively reported. The review descriptively summarises technological capabilities of flexible wearable closed-loop systems across four domains: skin bioinformation collection, biosignal monitoring, signal transmission and data analysis, and targeted intervention.

• Nnt Or Sensitivity: Not calculable from this review. Individual biosensor sensitivity and specificity data for specific analytes (e.g., glucose, pH, biomarkers) may be cited within the full text for individual devices, but no pooled diagnostic accuracy metrics are presented.

• Confidence Interval: Not reported — no confidence intervals are presented for any outcome.

Clinical Application

Clinical feasibility remains substantially unproven at scale. Key barriers include: regulatory approval pathways for combination diagnostic-therapeutic devices (which are classified as combination products in most jurisdictions); long-term biocompatibility and skin safety data; device durability, washability, and real-world wearability; data security and privacy for continuous biosignal transmission; integration with existing electronic health record systems; and cost-effectiveness relative to standard care. The review acknowledges challenges but does not provide solutions with supporting clinical evidence. In the Australian context, flexible wearable closed-loop devices of this nature would require TGA approval as medical devices under the Therapeutic Goods Act 1989, likely classified as Class IIb or Class III devices given their diagnostic and therapeutic functions. No currently PBS-listed item numbers exist for such devices. The RACGP does not yet have specific guidelines addressing closed-loop wearable skin management systems. The Australian Digital Health Agency's national digital health strategy and the My Health Record framework provide relevant infrastructure for data integration, but interoperability standards for novel wearable biosensor data streams remain underdeveloped. Australian wound care guidelines (e.g., from the Australian Wound Management Association) and diabetes management frameworks (NDSS) would be relevant reference points for specific applications. The technology described aligns with emerging interest in remote patient monitoring under MBS telehealth item numbers, but specific reimbursement pathways do not yet exist. Theoretically applicable to patients requiring continuous skin health monitoring or targeted dermatological therapy, including those with chronic wounds, diabetes-related skin complications, inflammatory skin conditions, and patients requiring transdermal drug delivery. However, the current evidence base is predominantly preclinical or early-phase, limiting immediate clinical applicability to any specific patient group.

Abstract

As the largest external barrier of the human body, the skin is essential to overall health and quality of life. Conventional skin health management faces limitations such as insufficient real-time monitoring and lack of personalization. Flexible wearable devices have recently emerged as a transformative technology, enabling non-invasive sensing and targeted therapy with high skin compatibility. This review comprehensively summarizes recent advances in flexible wearable closed-loop diagnostic and therapeutic systems for skin health management. It outlines the core technological components, including skin bioinformation collection, biosignal monitoring, signal transmission and data analysis, and targeted intervention. Key applications in physiological and pathological monitoring, wound healing, drug delivery, and physical therapy are discussed. Furthermore, the innovation trajectory of closed-loop systems is clarified, key challenges are analyzed, and targeted solutions are proposed. Future directions are prospected from cross-disciplinary views including digital twins and personalized medicine, establishing a new paradigm for real-time, personalized, and continuous skin health management.

References

1. 1.Gong, W., Yue, Z., Luo, Z., Wang, C., Zhu, Z., Ni, Z., & Xiang, N. (2026). Flexible wearable closed-loop diagnostic and therapeutic system: A new paradigm for skin health management. ACS Sensors. https://doi.org/10.1021/acssensors.6c00786