Regulatory challenges in robotics

EHRA Congress 2025 | Dr. Michiel Algoet (Leuven, Belgium) gives an insight into the current developments in the field of heart surgery through robotics and their ability in providing less invasive procedures, faster recovery times and lower complication rates. While the use of robotics has great potential, especially in combination with artificial intelligence, regulatory challenges also need to be considered. Measures designed to ensure patient safety slow down innovation at the same time. Algoet outlines the differences between the regulatory processes in the USA and Europe and shares his vision on future operating theaters.