2025 was a milestone year for ThrombUS+. The project registered our multi-center clinical trial, demonstrated working prototypes at two consortium meetings, released our first public ultrasound dataset, and presented research at conferences across Europe.
Clinical Trials Progress
The ThrombUS+ multi-center Clinical Study A was officially registered on ClinicalTrials.gov (NCT06989255), with active patient recruitment now underway across hospitals in Greece, France, Italy, and Lithuania. With over 3,000 participants targeted, Study A is building a comprehensive dataset of compression ultrasound images that will serve as a foundational resource for AI training in DVT detection.
Studies B1 and B2 were also launched this year. Study B1 aims on collecting compression ultrasound videos of patients suspected of having DVT, utilizing the Prototype ThrombUS+ Ultrasound system. The collected data will be used to fine-tune the AI models for the ThrombUS+ probes, enabling highly efficient autonomous DVT detection. Study B2 focuses on physical activity data collection using commercial inertial measurement units (IMUs) and camera sensors to develop and train our limb activity monitoring algorithms.
The first ThrombUS+ Ultrasound Dataset has been published on Zenodo as Open Access, making anonymized compression ultrasound videos from lower limb scans available to the research community. To facilitate model development and promote transparency in model accuracy and efficiency, the dataset was split into Training and Testing data sets. In addition, two Data Challenges have been developed with submissions currently open (Challenge_1 & Challenge_2). Data challenges are also part of BIOSTEC 2026 Conference as a dedicated Workshop.
Breakthroughs & Prototypes
2025 saw major advances in all our core technology components:
DVT Data Acquisition and Management for Clinical Trials – We created a systematic approach to collecting, processing, and utilizing ultrasound data from 3,000 patients to develop robust AI-driven diagnostic models. This streamlined workflow ensures high-quality, standardized datasets that form the foundation for our machine learning algorithms.
Wearable Compression Ultrasound System – Our breakthrough system combines Vermon's novel wearable linear ultrasound probe, Telemed's ultra-portable beam-former, KTU's silent tissue compression actuator, and a semi-rigid wearable from ComfTech. This technology enables non-invasive, automated DVT detection at the point of care.
Electrical Impedance Plethysmography (EIP) – Tampere University developed a complementary approach to DVT monitoring, combining the EIP system with evidence-based physical therapy protocols.
Limb Activity Monitoring – Our 10-sensor precision motion tracking system provides real-time leg position feedback and engages patients through serious gaming applications for DVT prevention.
Extended Reality & Serious Gaming – The XR module transforms DVT rehabilitation into an engaging, interactive experience, combining immersive technology with evidence-based therapy protocols.
Wearable Strap and Sock Prototypes – ComfTech delivered the first prototypes of our sensorized garments integrating the various monitoring technologies.
We've produced demonstration videos for each of these systems—you can watch them here on our website and YouTube channel.
US-DICOMizer – An advanced application for anonymizing ultrasound DICOM images, ensuring GDPR compliance while enabling secure data sharing
Physical Activity Recording Studio – Software for Study B2 data collection with IMU synchronization and video recording
Ultrasound Data Collection Manual and Annotation Manual – Standardized protocols for our multi-center study
Associated Partners
The consortium also welcomed DyoDelta Biosciences, Griffiths and Nielsen, Eris Enterprises, and Alpha Pliroforiki to the project. Associated Partners gain preliminary and detailed knowledge of project public deliverables and collaborate on certain research and innovation areas with ThrombUS+ partners, producing collaborative research and innovation submitted to the project.
Publications & Presentations
Papers
- Grandone E et al. – “Perinatal outcome in pregnant women: the impact of blood transfusion” – Blood Transfusion, January 2025
- Pechlivanis D, Didaskalou S, Kaldoudi E, Drosatos G – “Preparing Ultrasound Imaging Data for Artificial Intelligence Tasks: Anonymisation, Cropping, and Tagging” – BIOSTEC 2025, Porto, February 2025
- Jurkonis R, Eitminavičius R, Marozas V, Sakalauskas A – “Automating Compression Ultrasonography of Human Thigh Tissue and Vessels via Strain Estimation” – BIOIMAGING 2025, February 2025
- Prinz T, Narten Z, Wenner H, Didaskalou S, Kaldoudi E, et al. – “MD CoDe – Compliance by Design” – VDE DGBMT White Paper, April 2025
The “Compliance by design” approach integrates regulatory requirements into the medical device design and development process from the outset, maximizing efficiency and innovation while saving resources.
- Grandone E et al. – “Identifying Thromboprophylaxis and Aspirin Use in Pregnancy: Predictors and Maternal Outcomes-the Italian MoMs Study” – Thrombosis and Haemostasis, December 2025
- Grandone E, Marongiu F, Barcellona D – “From Puerperal Fever to Ovarian Vein Thrombosis: An Historical Journey and Contemporary Challenges in Diagnosis and Management” – Seminars in Thrombosis and Hemostasis, July 2025
- Voelz U, Betz B, Kircher M, Koeble S – “Wearable CMUT-Array for Online Monitoring of Blood Flow” – MikroSystemTechnik (MST) Congress, Duisburg, Germany, October 2025
Conference Presentations
Partners presented ThrombUS+ research at multiple international venues this year:
- SICVE 2025 National Congress in Padova – “Artificial Intelligence and Wearable Technology for Early Diagnosis of Deep Vein Thrombosis”
- BIOSTEC 2025 in Porto – Multiple presentations on ultrasound data preparation and automated compression ultrasonography
- AI in Healthcare Seminar in Athens – “Artificial Intelligence in Health – Successes and Challenges” presented by Project Director Eleni Kaldoudi
- MEDNIGHT in Xanthi – “A smart wearable device against deep vein thrombosis” was presented by Project Coordinator Stylianos Didaskalou to the Greek public, where participants got to try our XR and serious gaming system firsthand.
Consortium Meetings
Meeting #3: Foggia, Italy
Our third in-person meeting brought the consortium together for two exciting and productive days hosted by CSS-IRCCS. The agenda featured technical presentations and work package updates, culminating in live prototype demonstrations where various elements of the ThrombUS+ device were displayed and tested by consortium members.
Meeting #4: Tampere, Finland
The consortium meeting hosted by Tampere University featured fruitful technical discussions, prototype demos, and workshops. We also enjoyed unforgettable cultural exchange including Finnish sauna, karaoke, and even traditional Greek dancing! Opa!
Deliverables & Milestones
We submitted 15 major deliverables including:
Prototypes:
- Ultrasound transducer array prototypes (both PZT and MEMS technology)
- Precise tissue compression actuator prototypes
- Wearable strap and sock prototypes with integrated sensors
- Electrical Impedance Plethysmography, Light Reflection Rheography, and activity monitoring sensor systems
Technical Reports:
- Product design specifications
- Testing methodology and test plan
- Comprehensive testing reports for ultrasound arrays and wearable sensors
Clinical:
- Midterm clinical recruitment reports
- Clinical studies initiation packages for Studies B1 and B2
- Ultrasound data collection and annotation manuals
2025 also saw the end of the first reporting period, and the project implementation was deemed satisfactory following the interim report to HaDEA. A presentation with the project’s overall progress from the first 18 months will be uploaded shortly.
Thank You!
We deeply appreciate the dedication of our entire consortium, the support of the European Union's Horizon Europe programme, and the patients and volunteers participating in our clinical studies.
ThrombUS+ Partners
1) Athena Research Center, Greece
2) Kaunas University of Technology, Lithuania
3) Vermon SA, France
4) Fraunhofer IPMS, Germany
5) Telemed Ultrasound Medical Systems, Lithuania
6) EchoNous, USA
7) medis Medizinische Messtechnik GmbH, Germany
8) ComfTech srl, Italy
9) Tampere University, Finland
10) Lietuvos sveikatos mokslų universitetas (LSMU), Lithuania
11) Papageorgiou General Hospital, Greece
12) Fondazione Casa Sollievo della Sofferenza, Italy
13) Hôpital Simone Veil – Groupement hospitalier Eaubonne-Montmorency, France
14) VDE, Germany
15) Medea Project, Italy
16) Phaze Clinical Research & Pharma Consulting S.A., Greece
17) PredictBy, Spain
18) SciGen Technologies, SA., Greece
Here's to continued progress in 2026!
The ThrombUS+ project, an initiative to create a wearable device for the early detection of deep vein thrombosis, is funded by the European Union's Horizon Europe research and innovation programme under grant agreement No. 101137227.
