ABSTRACT
Artificial intelligence (AI) and machine learning (ML) have significantly impacted the field of cardiovascular medicine, especially cardiac electrophysiology (EP), on multiple fronts. The goal of this review is to familiarize readers with the field of AI and ML and their emerging role in EP. The current review is divided into 3 sections. In the first section, we discuss the definitions and basics of AI, ML, and big data. In the second section, we discuss their application to EP in the context of detection, prediction, and management of arrhythmias. Finally, we discuss the regulatory issues, challenges, and future directions of AI in EP.
ABSTRACT
The Food and Drug Administration (FDA) is a large regulatory agency that monitors everything from food, tobacco, and veterinary medicine to pharmaceutical drugs and medical devices. The Mission statement of the CDRH, one of the Centers of the FDA, in its most succinct form is to protect and promote public health. This is accomplished through timely and continued access to safe, effective, and high quality medical devices. This paper aims to review the overarching principles of the Agency's review process for cardiac devices as well as highlight some of the newer programs that FDA has engaged in to facilitate innovation, device development, research, and timely market approval.
