• technology

As a result of the collaboration between scientists, physicians, the pharmaceutical and medical device industry, and overseeing regulatory bodies such as the Food and Drug Administration (FDA), the diagnosis and treatment of many diseases has advanced dramatically in recent decades. This partnership and process has helped to progress—and in some cases revolutionize—the neurointerventional (NI) care of those with devastating diseases such as complex or giant cerebral aneurysms and emergent large vessel occlusive acute ischemic stroke.1 Recent advances within our dynamic space is undeniably tied to medical device innovation. The cost for this progress in terms of time and capital is considerable. It comprises research and development at the front end, regulatory review and approval in the middle and manufacture and marketing at the tail end. This editorial comment is intended to briefly review the regulatory pathways and processes for NI device approval and monitoring that are overseen by the FDA, and also seeks to highlight the ever more apparent need for a more rigorous post-market device reporting system.

The vital partnership between clinicians, industry and the FDA has been at the core of advances in healthcare, which in turn have directly benefited thousands of patients throughout the world. As in most endeavors, it is important to periodically review these regulatory and monitoring pathways as opportunities for process improvement are potentially available. The voluntary recall of Penumbra’s Jet7 reperfusion catheter with Xtra Flex technology (Penumbra, Alameda, California, USA) has provoked debate regarding the current post-market device monitoring systems in terms of patient safety and device effectiveness, a topic of historic interest in this journal.2–5

Several regulatory pathways exist to bring a medical device to market and they are largely defined by a risk-based approach.6 These pre-market approval processes are overseen by the Center for Devices and Radiological Health …