Czech medtech startup HTG Medical has achieved two major milestones that position the company for international growth: its flagship HTG Urogram has received CE certification under the European Union’s Medical Device Regulation (MDR), while the company has surpassed €1 million in total funding following a new pre-seed investment round.
The Prague-based startup is tackling one of intensive care’s most overlooked yet time-consuming workflows—manual urine output monitoring. By automating the process and integrating data directly into hospital information systems, HTG Medical aims to reduce administrative burden for healthcare professionals while improving patient monitoring.
Modernizing a Decades-Old ICU Workflow
In intensive care units, nurses are traditionally required to manually measure and record a patient’s urine output every hour. Although routine, the process consumes valuable clinical time and remains vulnerable to human error.
HTG Medical’s HTG Urogram replaces this manual workflow with continuous automated monitoring. The device measures urine output in real time, displays results on an integrated screen, and automatically transfers data into Hospital Information Systems (HIS).
According to the company, the solution can save nurses up to one hour per day, allowing them to spend more time on direct patient care instead of repetitive documentation.
Automation also improves data quality. Research cited by the company indicates that manual fluid monitoring in intensive care units can produce error rates of up to 26%, while continuous digital monitoring enables clinicians to identify important trends that may otherwise go unnoticed.
Earlier Detection of Kidney Injury
Beyond reducing administrative work, HTG Medical believes continuous monitoring can improve clinical decision-making.
“Continuous monitoring of urine output provides something that hourly manual checks never can—a trend,” said Dr. Marek Šramko, Head of the Cardiovascular ICU at Prague’s IKEM hospital.
According to Dr. Šramko, continuous measurements can support earlier identification of Acute Kidney Injury (AKI) and improve compliance with internationally recognized KDIGO clinical guidelines.
The system has already been used for several months in clinical practice at IKEM, one of the Czech Republic’s leading medical institutions.
Passing One of Europe’s Toughest Regulatory Hurdles
Receiving CE certification under the EU Medical Device Regulation (MDR) represents a significant achievement for the young company.
Since MDR replaced the previous regulatory framework, medical device certification has become considerably more demanding, requiring extensive technical documentation, rigorous quality management systems, and comprehensive clinical validation.
HTG Medical completed the entire certification process in approximately 15 months, supported by localized European manufacturing and full component traceability.
The certification allows immediate commercialization across European markets while also serving as a foundation for regulatory approvals in additional international markets.
Funding to Accelerate International Expansion
Alongside regulatory approval, HTG Medical completed a new €450,000 tranche of its pre-seed financing round.
The investment was led by Garage Angels, with participation from Electron Capital Partners, JIC Ventures, and existing investors Jinej fond and Dendis Capital.
The new financing brings the company’s cumulative funding to more than €1 million.
According to the founders, investor demand significantly exceeded expectations, with soft commitments surpassing €1 million—more than double the original fundraising target.
The capital will support commercial expansion across Europe while preparing regulatory registrations in additional markets, including Australia, Singapore, Malaysia, and Saudi Arabia.
From Hackathon Prototype to Certified Medical Device
HTG Medical’s journey began in 2019 during a medical innovation hackathon organized by Prague’s IKEM hospital, where the founding team was challenged to digitize urine output monitoring.
Although the project did not win the competition, the founders continued developing the concept into a fully certified medical device.
Founded in 2021, the company has since completed several accelerator programs, including Caelestinus, ČSOB StartIt, and CzechInvest’s Tech4Life, while building a medical hardware platform focused on digitization and user experience for frontline healthcare professionals.
A Growing Opportunity in Hospital Automation
Healthcare systems across Europe continue to face staffing shortages and increasing pressure to improve efficiency without compromising patient care.
By automating one of the most repetitive monitoring tasks in intensive care, HTG Medical is positioning itself at the intersection of medical hardware, digital health, and hospital workflow automation.
With MDR certification secured and funding in place, the Czech startup is now moving from product development to commercial deployment, aiming to bring its ICU technology to hospitals across Europe and beyond.
