Nanomedicine, a convergence of nanotechnology and medical sciences, has unleashed transformative potential in healthcare. However, harnessing the benefits of nanomedicine requires a thorough understanding of its regulatory landscape. An in-depth discussion of regulatory considerations, including molecular safety assessment, harmonization of the regulatory landscape, and shaping the future of innovation, is presented in this discourse. The molecular safety assessment entails evaluating interactions between nanoparticles and biomolecules, ensuring compatibility at the molecular level. Harmonization involves developing international standards and guidelines for a consistent regulatory approach, while shaping innovations emphasizes integrating molecular safety assessments into early stages of development. Challenges encompass the need for standardized assessment methods, balancing innovation with safety, and addressing unique features of novel molecular designs. As the nanomedicine landscape evolves, effective regulatory strategies must navigate the intricate interplay of molecules and technologies, ensuring both patient access and product safety.

Neurodegenerative diseases (NDDs) gradually affect neurons impacting both their function and structure, and they afflict millions worldwide. Detecting these conditions before symptoms arise is crucial for better prognosis and duality of life, given that the disease processes often begin years earlier. Yet, reliable and affordable methods to diagnose NDDs in these stages are currently lacking. There’s a growing interest in using circulating extracellular vesicles (EVs), like small EVs (sEVs) also known as exosomes, as potential sources of markers for screening, diagnosing, and monitoring NDDs. This interest stems from evidence showing that these EVs can carry brain pathological proteins implicated in NDD pathology, and they can even traverse the blood-brain barrier. This review focuses on the creation of EVs, particularly sEVs with a size of less than 200 nanometers, methods for isolating sEVs, and recent advancements in biosensor development to detect NDD-related markers found in sEVs. Furthermore, it explores the potential of sEVs in diagnosing four major NDDs: Alzheimer’s disease (AD), Parkinson’s disease (PD), Huntington’s disease (HD), and multiple system atrophy (MSA).

Improving the performance of blood-contacting medical implants is a global health necessity aimed at reducing mortality and morbidity in patients with cardiovascular diseases. Surface modification of the biomaterials from which the vascular grafts are constructed has been used to reduce the risk of complications such as thrombosis and infection. Herein with a focus on vascular tissue engineering, we provided an overview of (a) fundamental hemodynamic considerations for blood-contacting biomaterials, (b) surface modification strategies to attenuate nonspecific adhesion of proteins, improve hemocompatibility, and induce the formation of a confluent endothelial lining, and (c) the guidelines for the clinical development of surface modified biomaterials.

Nanoparticles (NPs) are at the forefront as they are providing unprecedented solutions to obstacles and issues in treating neurodegenerative diseases. Due to their size, surface characteristics, and ability to be functionalized, these carriers can directly deliver therapeutics across what is considered one of the main barriers to central nervous system (CNS) treatment, the blood-brain barrier (BBB). Through nano-technology, anti-disease agents such as Alzheimer’s, Parkinson’s, and Huntington’s therapies become more bioavailable, specific in action, and with fewer side effects. The NPs serve as molecular carriers that facilitate transport across the BBB by receptor-mediated transcytosis or by disruption of the barrier with a view to properly delivering drugs to the neural tissues. Some of the therapeutic applications of nanotechnology also present the concept of molecular medicine since the NPs are designed to deliver drugs in accordance with specific biomolecule signals. Besides the therapeutic applications, NPs replace the traditional contrast media for magnetic resonance imaging (MRI) and positron emission tomography (PET) scans for better diagnosis as well as disease tracking in the early stages. In addition, their effects on solubility increase the therapeutic potential of earlier useless compounds, and the preservation of bioactive molecules from degradation increases the therapeutic capacity of medications. Neurodegenerative disorders are marked by oxidative stress and inflammation that contribute to the disease severity; thus, liposomes, dendrimers, and polymeric NPs encapsulate antioxidants and anti-inflammatory compounds, so they target the areas most affected by the disease. Such sophisticated systems minimize the extension of neuronal deterioration and enhance the lot of such patients. The “theranostic” NPs allow for continuous diagnosis and treatment by containing both diagnostic and therapeutic features. These have created unprecedented opportunities to meet the unmet needs in CNS disorders and may revolutionize the evolution of managing neurodegenerative diseases and innovative neuroimaging procedures in the future.