Essenvia will present its comprehensive report encapsulating the dynamic regulatory landscape in the US MedTech industry and spotlighting pivotal changes in 2023. It details significant growth in device approvals, with an emphasis on the acceleration of De Novo clearances and PMAs, highlighting the FDA’s commitment to fostering medical innovation. Additionally, the report discusses the impact of digital health policies, the integration of AI/ML technologies, and the critical role of cybersecurity. It also delves into the strategic importance of eSTAR implementation and the rising trend of Breakthrough Device Designations, providing MedTech professionals with actionable insights and foresight into regulatory trends and market opportunities in 2024 and beyond.