Artificial Intelligence (AI) and Machine Learning (ML) are revolutionizing the healthcare industry. However, their rapid evolution presents unique regulatory challenges. As AI algorithms become more sophisticated and adaptive, traditional regulatory frameworks may struggle to keep pace.
The FDA, a global leader in medical device regulation, is closely monitoring these developments. While the number of AI-enabled devices has increased from 650 to 950 over a year, the agency has yet to authorize any devices using generative AI or large language models.
