HTG Medical raises €450k and secures MDR certification to automate ICU urine monitoring

Czech medtech startup HTG Medical has secured €450,000 in funding and achieved crucial EU Medical Device Regulation (MDR) certification for its innovative HTG Urogram device. This dual success positions the company for immediate rollout of its automated ICU urine monitoring system across European and global markets. The Urogram automates a previously manual and time-consuming task, promising significant efficiency gains for healthcare professionals. The HTG Urogram automates the tracking of patient fluid output, a critical but often manual process in intensive care units. This system displays real-time metrics on an integrated screen and seamlessly transmits data directly to Hospital Information Systems (HIS), eliminating the need for nurses to physically check and log output hourly. By automating this process, the device is expected to return up to one hour of valuable time daily to nurses, allowing them to focus on direct patient care and significantly reducing the potential for human error, which external research indicates can reach up to 26% in manual fluid tracking. Securing the CE mark under the stringent MDR certification validates HTG Medical's meticulous development process, from understanding real-world clinical needs to ensuring measurement accuracy, engineering reliability, and secure data integration. This certification serves as a regulatory springboard, facilitating expedited registrations in numerous international markets beyond Europe. The company's rapid navigation of the complex certification process, completed in 15 months, underscores its robust institutional processes and commitment to building a scalable, compliant business foundation.