EMA Holds Multistakeholder Workshop on Innovation in Cardiovascular Medicines and Medical Devices
The European Medicines Agency held a multistakeholder workshop titled “Supporting Innovation in Cardiovascular Medicines and Medical Devices in the EU” on 1–2 July 2026.
The workshop focused on innovation in cardiovascular medicines and medical devices, bringing together presentations on development challenges, unmet needs, regulatory science, clinical research, digitalisation, artificial intelligence and emerging technologies.
Focus on Cardiovascular and Cardiometabolic Innovation
The programme included several presentations addressing cardiovascular and cardiometabolic disease areas.
Topics included adiposity as a gateway to cardiometabolic diseases, unmet needs in cardiovascular risk reduction and lived experience in unmet need.
These themes highlight the continuing importance of innovation across prevention, diagnosis, treatment and patient management in cardiovascular care.
Regulatory Science and Medical Devices
The workshop also included a dedicated presentation on clinical imperatives for implementing regulatory science for medical devices.
This indicates the relevance of regulatory science in supporting safe, effective and timely development of cardiovascular medical technologies in the EU.
AI and Digital Technologies
Artificial intelligence and digital technologies were also prominent themes.
The programme included sessions on AI and digital technologies transforming cardiovascular device innovation, artificial intelligence for drug development in cardiovascular medicine, AI in cardiovascular care and fostering innovation in cardiovascular diseases with digitalisation and AI.
For medical device manufacturers, these topics are particularly relevant as digital tools, AI-enabled technologies and connected healthcare solutions continue to influence cardiovascular device development.
Emerging Devices and Therapies
The workshop also addressed the state of play and key questions for emerging and innovative devices and emerging and innovative therapies.
These sessions suggest a broader discussion around how innovation can be supported across both medical device and medicinal product pathways in cardiovascular disease.
Impact on Medical Device Manufacturers
For medical device manufacturers working in cardiovascular care, the workshop highlights several important areas to monitor:
regulatory science for medical devices;
clinical research challenges and opportunities;
unmet needs in cardiovascular and cardiometabolic disease;
AI-enabled cardiovascular device innovation;
digital health and digitalisation;
emerging and innovative devices;
global collaboration in cardiovascular medicine development;
patient experience and unmet clinical needs.
For manufacturers developing cardiovascular medical devices, the key message is that innovation is increasingly linked to clinical evidence, regulatory science, digital transformation and collaboration across medicine and device stakeholders.
