WARD 24/7 Receives FDA Clearance for WARD-CSS®, Revolutionizing Continuous Patient
Monitoring
Today WARD 24/7 announced it has received 510(k) clearance from the U.S. Food and Drug
Administration (FDA) for its WARD-CSS (Clinical Support System), a Software as a Medical
Device (SaMD) designed to enhance patient safety and help healthcare professionals know when to
act through continuous monitoring. This clearance marks a significant milestone for the Danish
scale-up company, validating the company's commitment to innovating healthcare technology.
WARD-CSS addresses critical challenges in hospital settings, particularly in general medical-
surgical floors and emergency departments (EDs), by providing continuous, non-invasive patient
monitoring. The system aims to detect vital sign deviations and thereby to reduce critical
complications and potentially eliminate unwitnessed "dead in bed" situations, a long-standing
concern in healthcare. By providing real-time data and alerts through continuous monitoring,
WARD-CSS enables timely intervention, supporting improved patient outcomes.
“We are incredibly proud to receive FDA clearance for WARD-CSS“ said Betina Langemark, CEO
of WARD 24/7. "This clearance is not just an approval; it's a testament to the quality and efficacy
of our technology. WARD-CSS addresses a significant need in the U.S. healthcare system by
enhancing patient safety, reducing costs, and providing peace of mind to nurses through continuous
monitoring."
Key benefits of continuous monitoring with WARD-CSS include:
• Reduce critical complications by detecting vital sign deviations: Continuous monitoring
on general medical-surgical floors and in EDs ensures timely response to critical events.
• Potential Reduction of Hospital Costs: By enabling timely intervention, continuous
monitoring with WARD-CSS helps hospitals mitigate the substantial costs associated with
adverse events.
• Enhanced Nursing Efficiency: The system eliminates the need for frequent manual
monitoring and supports workflow efficiency with multiple functions co-developed with
nurses, allowing nurses to focus on direct patient care.
• Enabling Hospital@Home: WARD-CSS supports remote patient monitoring, making
hospital-level care possible in home settings with 24/7 monitoring.
WARD-CSS has already been launched in several Nordic and European countries in 2024,
demonstrating its effectiveness in diverse healthcare environments. With FDA clearance, WARD
24/7 is set to initiate pilot programs in the United States, led by CEO Betina Langemark, CMO
Katja Kjær Grønbæk, and a dedicated U.S.-based team.
"Our team has worked diligently to bring this innovative technology to the U.S. market," said
Betina Langemark. "We are excited to partner with hospitals and healthcare providers to implement
WARD-CSS and improve patient safety across the country through continuous monitoring."
About WARD-CSS
WARD-CSS is an advanced digital and mobile clinical support system that enables staff on all
floors to monitor and document patients' vital signs on their work phones continuously around the
clock - without drowning in endless alarms. WARD-CSS enables correct prioritization and rapid
response in critical situations and frees up resources that would otherwise be spent on manual
measurements and treating complications that are detected too late. But perhaps most importantly,
continuous monitoring contributes to more efficient and safe care for both patients and staff when
deteriorations are detected in time.
Numerous Danish and international studies highlight the need for continuous vital sign monitoring
in hospital patients to prevent unexpected, costly deteriorations—even in regular units. Before
WARD-CSS, this wasn't feasible due to excessive, unmanageable alarms. Now, for the first time,
WARD-CSS enables effective monitoring by reducing alarms with clinically validated, FDA
cleared, and MDR class IIa-certified algorithms that ensure only relevant vital sign deviations
trigger alerts. Without requiring staff to adjust system or sensor settings for each department and
patient, WARD-CSS connects to all hospital-approved continuous vital sign sensors, integrates with
existing login systems, and documents values directly into patient records with a simple bedside
swipe!
WARD-CSS was developed through a private-public research collaboration with Rigshospitalet and
Bispebjerg Hospital, ensuring a strong foundation in research and clinical expertise. This approach,
combined with a focus on nurses' daily workflows, has resulted in a solution uniquely optimized for
real-world clinical practice.
About WARD 24/7
WARD 24/7 is a leading innovator in healthcare technology, specializing in the development of
advanced monitoring software. The company is committed to improving patient outcomes and
streamlining hospital operations through cutting-edge technology.