AI-Powered Medical Devices: Innovation, Regulation, and Clinical Impact

Abstract

Artificial intelligence (AI) has transformed the modern medical landscape. Medical devices benefit from innovative data collection, utilization of machine learning, predictive analytics, and intelligent decision support systems in their design and implementation. Applications include medical devices for diagnosis, screening, patient monitoring, tailored care, robotic procedures, and streamlining hospital processes. Despite these benefits, the development of new AI-powered devices presents many new regulatory, legal, ethical and cyber security challenges to be addressed. This research paper provides a review of the recent literature regarding advances in AI-powered medical devices, including their mechanisms of action, clinical applications, regulation, and regulation challenges. A qualitative narrative review was performed synthesizing the content of 15 carefully selected papers that fit the inclusion criteria. An analysis revealed that AI-powered medical devices have improved accuracy in diagnosis, enabled precision care, advanced patient monitoring, and optimized component manufacturing. Our review further identified a future where evolving regulation frameworks, such as risk-based control strategies, as well as increased explainability, interpretability, infrastructure protection, and compliance will help to facilitate widespread AI adoption in medicine.