Year: 2026
Type: article
Abstract: The use of endovascular devices has completely changed the way in which problems of the cardiovascular and neurovascular systems are managed. These devices provide minimally invasive options that decrease the amount of time patients spend recovering and lessen the severity of their illnesses. Nevertheless, the rate at which they have been advancing technologically has exceeded the capabilities of the regulatory procedures that are already in place, resulting in substantial obstacles when it comes to guaranteeing safety, efficacy, and post-market surveillance. The present paper investigates the regulatory frameworks that are currently in place to govern endovascular devices in major jurisdictions. The investigation highlights a number of important issues, including the following: differences in the pathways that lead to approval, a scarcity of long-term clinical data, difficulties associated with evaluating interactions between devices and tissues, and the increasing dependence on digital components and software algorithms in the performance of devices. There are other difficulties that have to be taken into consideration, such as the inconsistency of global standards, the sluggish pace of harmonization efforts, and the inadequacy of systems that are used to monitor the consequences of real-world device use, particularly in nations with low and moderate incomes. The necessity of adaptive regulatory frameworks that combine riskbased assessment, constant evidence development, and greater international collaboration is highlighted by the analysis. Among the policy proposals are the following: the enhancement of mechanisms for post-market surveillance, the encouragement of uniform reporting standards, the incorporation of concerns related to cybersecurity and digital health, and the cultivation of policies that are conducive to innovation without compromising the safety of patients. The resolution of these inadequacies will enable regulatory agencies to provide more robust support for the safe and successful implementation of the next generation of endovascular devices, as well as to enhance clinical results on a global scale.
Institutions: ICFAI University, Dehradun, Quantum University
Language: English
Topic: Healthcare Regulation
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W7153133003