Concerns over the FDA's ability to regulate AI medical devices are increasing, with experts calling for more rigorous clinical validation data to ensure patient safety. Meanwhile, fears are rising about the potential misuse of AI in creating bioweapons, particularly in the context of pandemics, prompting calls for structured government oversight. A recent MIT report has highlighted nearly 700 types of AI-related risks, emphasizing the importance of regulation to mitigate these dangers. Concurrently, Fortune 500 companies are expressing alarm over the rapid rise in AI as a business risk, with a 500% increase in mentions between 2022 and 2024, amid uncertainties about future regulations. Additionally, organizations are grappling with rising bot attacks fueled by AI, resulting in significant revenue losses and increasing concerns about the effectiveness of current mitigation strategies. Collectively, these issues underscore the urgent need for comprehensive AI regulation across various sectors.