Device innovation in cardiovascular medicine: a report from the European Society of Cardiology Cardiovascular Round Table

Foster an environment conducive to medical technology development and validation, while providing high standards of safety

After successful early feasibility studies, ideally RCTs comparing novel devices vs accepted standards of care when available, and post-market real-world evidence through registries

Standards are needed for smart devices and digital technologies that support device-driven biomonitoring

Device development programmes, including dialogue on unmet needs and advice on study designs, must be driven by a community of physicians, trialists, patients, regulators, payers and industry