Artificial Intelligence (AI) has the potential to revolutionise the healthcare industry by enhancing diagnostic accuracy, treatment efficiency, and patient care.
AI technologies, such as machine learning (ML), natural language processing (NLP), or computer vision (CV), have shown promise in various medical applications, including image analysis (radiology), disease prediction, drug discovery, and personalised medicine. AI-enabled medical devices leverage machine learning algorithms and advanced data analysis techniques to provide actionable insights from medical data. These technologies can help physicians make more informed decisions, improve patient outcomes, and streamline healthcare processes.
Brought to you by our Regulatory team, the free whitepaper below provides an overview of the regulatory frameworks for incorporating Artificial Intelligence (AI) in medical devices in the European Union (EU) and the United States (US). It examines the current key regulatory considerations and approval pathways for AI-driven medical devices in the EU and US and outlines the current AI standardisation efforts, as well as a projected view of what the future may hold from a regulatory perspective for AI-enabled medical devices in both regions. You can access the whitepaper at the “Download” link below.
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