(Frankfurt a. M., 24.05.2024) Small clot – big consequences: Deep vein thrombosis (DVT) poses a significant health risk worldwide and can even have life-threatening consequences. Although they can be treated, unfortunately they are often only recognized late. The reason: up to two thirds of cases show no symptoms. An international team of experts wants to close this gap. Their idea: a portable diagnostic device that uses artificial intelligence (AI) to monitor patients and detect blood clots at an early stage. The use of the intelligent medical wearable is intended to reduce the burden on doctors and improve prevention and diagnosis. The ThrombUS+ project, which was launched in January and in which the VDE is also involved, is being funded for three and a half years with 9.5 million euros in the EU's Horizon Europe program.
AI in medicine: meeting challenges – seizing opportunities
"There are numerous challenges when developing a wearable for the diagnosis and prevention of deep vein thrombosis," explains VDE employee Thorsten Prinz. "On the one hand, the technical components must be miniaturized for the intended purpose without compromising the quality of the clinical data generated. On the other hand, there are regulatory challenges when placing a complex AI-based medical device on the market, such as the European Medical Device Regulation (MDR) or the AI Act recently passed by the EU Parliament, which sets out minimum requirements for trustworthy AI."
Together, the 18 interdisciplinary and international project partners from Greece (project lead Athena Research Center), Lithuania, France, Germany, Italy, Finland, Spain and the USA want to tackle the various challenges.
Early detection thanks to medical wearable
A look at the figures shows just how important early detection is: In around half of those affected by DVT, the blood clot, which impairs normal blood flow, particularly in the veins of the lower limbs, travels to the lungs, where it can cause a pulmonary embolism. Worldwide, pulmonary embolisms are the third most common cause of cardiovascular death after strokes and heart attacks.
To change this, the consortium is working on developing a portable and intelligent diagnostic technology. In the future, it should enable user-friendly, operator-free and continuous real-time monitoring for patients at high risk of DVT. The innovative approach combines AI-driven detection mechanisms based on ultrasound technology, impedance plethysmography (measurement of electrical AC resistance) and light reflection rheography (measurement using infrared light). The technical development is accompanied by clinical studies to ensure the safety and performance of the medical device.
The new technology will be used in particular for patients in the post-operative phase in hospital wards, during long-term surgical procedures, for cancer patients, bedridden people at home or in care facilities and women during and after pregnancy.
Bringing medical innovations to patients faster
The aim is to make the path of innovation to the patient as short as possible. To achieve this, the team incorporates legal, regulatory and safety requirements for complex medical devices into the development process as early as possible. "The VDE experts have in-depth specialist knowledge in the field of medical device regulation. This is why they ensure that the regulatory requirements are taken into account right from the start when developing and implementing the new AI-controlled technology," emphasizes Dr. Cord Schlötelburg, Head of the Health division at VDE.
Building on the clinical, technical and regulatory experience gained in the project, the aim is to sustainably improve the chances of future complex AI-based medical devices gaining market access.
