"There are many challenges in developing a portable solution for the diagnosis and prevention of thrombosis," explains Prof. Kaldoudi, project coordinator and scientist at the Athena Research Center in Greece. "We address these challenges not only from a technological perspective. A strength of the consortium lies in the application of a 'Compliance-by-Design' approach, which integrates legal, regulatory, and safety requirements for complex medical products into the development process as early as possible, thus shortening the path of innovation to patients."
The clinical, technical, and regulatory experiences gained within the ThrombUS+ project are expected to create new opportunities for market access for future complex AI-based medical products. The project paves the way for a new era in which portable devices and artificial intelligence enable continuous and autonomous point-of-care services. This significantly relieves medical professionals. The interdisciplinary and international composition of the consortium, comprising 18 European partners, plays a crucial role in its success.
MEDICA-tradefair.com; Source: Fraunhofer Institute for Photonic Microsystems (IPMS)