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Abstract Medical devices play a crucial role in modern healthcare, providing innovative solutions for diagnosing, preventing, monitoring, and treating ailments. Artificial Intelligence is transforming the field of medical devices, offering unprecedented opportunities through diagnostic accuracy, personalized treatment plans, and enhancing patient outcomes. This review outlines the applications of artificial intelligence-based medical devices in healthcare specialties, especially in dentistry, medical imaging, ophthalmology, mental health, autism spectrum disorder diagnosis, oncology, and general medicine. Specifically, the review highlights advancements such as improved diagnostic accuracy, tailored treatment planning, and enhanced clinical outcomes in the above-mentioned applications. Regulatory approval remains a key issue, where medical devices must be approved or cleared by the United States Food and Drug Administration to establish their safety and efficacy. The regulatory guidance pathway for artificial intelligence-based medical devices is presented and moreover the critical technical, ethical, and implementation challenges that must be addressed for large-scale adoption are discussed. The review concludes that the intersection of artificial intelligence with the medical device domain and internet-enabled or enhanced technology, such as biotechnology, nanotechnology, and personalized therapeutics, enables an enormous opportunity to accelerate customized and patient-centered care. By evaluating these advancements and challenges, the study aims to present insights into the future trajectory of smart medical technologies and their role in advancing personalized, patient-centered care. 

Designing and manufacturing devices at the micro- and nanoscales offers significant advantages, including high precision, quick response times, high energy density ratios, and low production costs. These benefits have driven extensive research in micro-electromechanical systems (MEMS) and nano-electromechanical systems (NEMS), resulting in various classifications of materials and manufacturing techniques, which are ultimately used to produce different classifications of MEMS devices. The current work aims to systematically organize the literature on MEMS in biomedical devices, encompassing past achievements, present developments, and future prospects. This paper reviews the current research trends, highlighting significant material advancements and emerging technologies in biomedical MEMS in order to meet the current challenges facing the field, such as ensuring biocompatibility, achieving miniaturization, and maintaining precise control in biological environments. It also explores projected applications, including use in advanced diagnostic tools, targeted drug delivery systems, and innovative therapeutic devices. By mapping out these trends and prospects, this review will help identify current research gaps in the biomedical MEMS field. By pinpointing these gaps, researchers can focus on addressing unmet needs and advancing state-of-the-art biomedical MEMS technology. Ultimately, this can lead to the development of more effective and innovative biomedical devices, improving patient care and outcomes. 

Microcapsules provide a microenvironment by improving the protection and delivery of cells and drugs to specific tissue areas, promoting cell integration and tissue regeneration. Effective microcapsules must not only be permeable for micronutrient diffusion but mechanically stable. Alginate hydrogel is one of the commonly used biomaterials for fabricating microcapsules due to its gel-forming ability and low toxicity. However, its mechanical instability, inertness, and excessive porosity have impeded its use. Embedding nanofibrils in the alginate hydrogel microcapsules improves their biological and mechanical properties. In this research, electrospun composite nanofibers of PCL–gelatin (PG) were first fabricated, characterized, and cryoground. The filtered and cryoground powder solution was mixed with the alginate solution and through electrospray, fabricated into microcapsules. Parameters such as flow rate, voltage, and hydrogel composition, which are critical in the electrostatic encapsulation process, were optimized. The microcapsules were further immersed in different solvent environments (DI water, complete media, and PBS), which were observed and compared for their morphology, size distribution, and mechanical stability properties. The average diameters of the PG nanofibers ranged between 0.2 and 2 μm, with an average porosity between 58 and 73%. The average size of the microcapsules varied between 300 and 900 μm, depending on the solvent environment. Overall, results showed an improved alginate 3D hydrogel network suitable for biomedical applications. 

Nanomanufacturing and digital manufacturing (DM) are defining the forefront of the fourth industrial revolution—Industry 4.0—as enabling technologies for the processing of materials spanning several length scales. This review delineates the evolution of nanomaterials and nanomanufacturing in the digital age for applications in medicine, robotics, sensory technology, semiconductors, and consumer electronics. The incorporation of artificial intelligence (AI) tools to explore nanomaterial synthesis, optimize nanomanufacturing processes, and aid high-fidelity nanoscale characterization is discussed. This paper elaborates on different machine-learning and deep-learning algorithms for analyzing nanoscale images, designing nanomaterials, and nano quality assurance. The challenges associated with the application of machine- and deep-learning models to achieve robust and accurate predictions are outlined. The prospects of incorporating sophisticated AI algorithms such as reinforced learning, explainable artificial intelligence (XAI), big data analytics for material synthesis, manufacturing process innovation, and nanosystem integration are discussed. 

The food industry is one of the most regulated businesses in the world and follows strict internal and regulated requirements to ensure product reliability and safety. In particular, the industry must ensure that biological, chemical, and physical hazards are controlled from the production and distribution of raw materials to the consumption of the finished product. In the United States, the FDA regulates the efficacy and safety of food ingredients and packaging. Traditional packaging materials such as paper, aluminum, plastic, and biodegradable compostable materials have gradually evolved. Coatings made with nanotechnology promise to radically improve the performance of food packaging materials, as their excellent properties improve the appearance, taste, texture, and shelf life of food. This review article highlights the role of nanomaterials in designing and manufacturing anti-fouling and antimicrobial coatings for the food packaging industry. The use of nanotechnology coatings as protective films and sensors to indicate food quality levels is discussed. In addition, their assessment of regulatory and environmental sustainability is developed. This review provides a comprehensive perspective on nanotechnology coatings that can ensure high-quality nutrition at all stages of the food chain, including food packaging systems for humanitarian purposes. 

Microneedle (MN) technology is an optimal choice for the delivery of drugs via the transdermal route, with a minimally invasive procedure. MN applications are varied from drug delivery, cosmetics, tissue engineering, vaccine delivery, and disease diagnostics. The MN is a biomedical device that offers many advantages including but not limited to a painless experience, being time-effective, and real-time sensing. This research implements additive manufacturing (AM) technology to fabricate MN arrays for advanced therapeutic applications. Stereolithography (SLA) was used to fabricate six MN designs with three aspect ratios. The MN array included conical-shaped 100 needles (10 × 10 needle) in each array. The microneedles were characterized using optical and scanning electron microscopy to evaluate the dimensional accuracy. Further, mechanical and insertion tests were performed to analyze the mechanical strength and skin penetration capabilities of the polymeric MN. MNs with higher aspect ratios had higher deformation characteristics suitable for penetration to deeper levels beyond the stratum corneum. MNs with both 0.3 mm and 0.4 mm base diameters displayed consistent force–displacement behavior during a skin-equivalent penetration test. This research establishes guidelines for fabricating polymeric MN for high-accuracy and low-cost 3D printing. 

Notably, 3D-printed flexible and wearable biosensors have immense potential to interact with the human body noninvasively for the real-time and continuous health monitoring of physiological parameters. This paper comprehensively reviews the progress in 3D-printed wearable biosensors. The review also explores the incorporation of nanocomposites in 3D printing for biosensors. A detailed analysis of various 3D printing processes for fabricating wearable biosensors is reported. Besides this, recent advances in various 3D-printed wearable biosensors platforms such as sweat sensors, glucose sensors, electrocardiography sensors, electroencephalography sensors, tactile sensors, wearable oximeters, tattoo sensors, and respiratory sensors are discussed. Furthermore, the challenges and prospects associated with 3D-printed wearable biosensors are presented. This review is an invaluable resource for engineers, researchers, and healthcare clinicians, providing insights into the advancements and capabilities of 3D printing in the wearable biosensor domain. 

Bioprinting is a versatile technology gaining rapid adoption in healthcare fields such as tissue engineering, regenerative medicine, drug delivery, and surgical planning. Although the current state of the technology is in its infancy, it is envisioned that its evolution will be enabled by the integration of the following technologies: Internet of Things (IoT), Cloud computing, Artificial Intelligence/Machine Learning (AI/ML), NextGen Networks, and Blockchain. The product of this integration will eventually be a smart bioprinting ecosystem. This paper presents the smart bioprinting ecosystem as a multilayered architecture and reviews the cyber security challenges, vulnerabilities, and threats in every layer. Furthermore, the paper presents privacy preservation solutions and provides a purview of the open research challenges in the smart bioprinting ecosystem.