How do you build an AI medical device that meets EU MDR and AI Act requirements? Regulatory expert Thorsten Prinz of ThrombUS+ partner VDE explains the roadmap to compliance.
Pavlos Aplakidis
15 posts
Founded by Saint Pio in 1956, Casa Sollievo della Sofferenza combines compassionate care and scientific excellence. Now a leading Italian Research Hospital (IRCCS), it contributes specialized expertise in pregnancy-related thrombosis to the ThrombUS+ European Project.
Tasked with creating a novel device for the early detection of DVT, ThrombUS+ made great strides in 2025 including new prototypes, the initiation of clinical trials, and advancements in scientific research.
Papageorgiou General Hospital is one of the largest and most prestigious hospitals in Greece, and a major partner involved in the Clinical Studies of the ThrombUS+ project. ThrombUS+ is tasked with creating a wearable device for the autonomous detection of deep vein thrombosis.
The Lithuanian University of Health Sciences (LSMU), one of Europe's largest life sciences universities with over 8,000 students, contributes as the clinical partner to the ThrombUS+ Horizon Europe project developing innovative wearable technology for deep vein thrombosis detection and monitoring.
ThrombUS+ met in Tampere, Finland for our fourth project meeting in June 2025. We discussed project progress, demonstrated prototypes, shared technical presentations, and had an unexpected amount of fun
Tampere University is responsible for studying the use of electrical impedance plethysmography technology for detecting deep vein thrombosis in the ThrombUS+ project.
ComfTech is an innovative manufacturer of wearable monitoring systems based on smart garments. As part of the ThrombUS+ project, ComfTech contributes its expertise in smart textiles and wearable systems by designing sensorized garments for the early detection of deep vein thrombosis
medis GmbH: Expert developers of medical impedance measurement and Light-Reflection-Rheography technology for DVT detection in the ThrombUS+ project. Discover how their non-invasive diagnostic innovations are revolutionizing blood clot monitoring and prevention for cardiovascular health.
The ThrombUS+ Horizon Europe project, tasked with creating a wearable device for the early detection of Deep Vein Thrombosis, had its third in-person consortium meeting in Italy. The meeting featured technical presentations and progress updates.