Automated urine output measurement and documentation from the patient bed directly into the PDMS.
Elixion Medical GmbH
Düsseldorf (Lambertusstraße 1a) · Düsseldorf (Elisabethstr. 11)New on Amplifa
About Elixion Medical
Elixion Medical GmbH is a medical technology company from Düsseldorf specializing in automated patient monitoring through IoT and AI platforms. Its core product is the Niviu System for continuous, automated measurement of hourly diuresis on urinary catheters and drains: a reusable, battery-powered device on the urine bag measures the urine outflow, transmits the values via secured hospital Wi-Fi and automatically documents them in the patient data management system (PDMS) — via standardized HL7v2-ORU or FHIR interfaces. The central Niviu IoT Hub consolidates all devices, offering device management with automated OTA updates, LDAP authentication, and configurable measurement intervals and threshold alerts. The system is CE-certified under the MDR and ISO 13485 certified, and is live in European hospitals, including Essen University Hospital. The goal is to relieve the nursing team (about one hour per bed per day) and to provide more precise data for early detection of complications. The company was founded in 2021 after several years of development and clinical studies.
- Site
- Düsseldorf
- Processes
- IoT platform integration and deployment (HL7/FHIR), Clinical pilot installations and support with evaluation, Automated OTA updates and device management, Predictive analytics / AI for early complication detection
- Materials
- HL7v2 ORU / FHIR interfaces, Wi-Fi data transmission, OTA updates & LDAP, Machine Learning / Predictive Analytics
- Certificates
- ISO 13485, CE (MDR)
- Founded
- 2021
- Employees
- 1-50
- Industries
- Healthcare / Hospitals, Medical Technology, AI / IoT, SaaS
- 01
Development of the medical device (SmartDrain/Niviu)
- 02
Clinical studies and pilot installations
- 03
CE certification (MDR)
- 04
Deployment of the Niviu IoT Hub
- 05
Integration into the PDMS via HL7v2/FHIR
- 06
Device management including OTA updates
- 07
Predictive analytics / AI for early complication detection
Technologies & Interfaces
HL7v2 ORU / FHIR interfaces
Standardized interfaces for connecting the Niviu IoT Hub to the hospital PDMS.
Wi-Fi data transmission
Secured wireless transmission of measured values from the bedside device to hospital IT.
OTA updates & LDAP
Automated firmware updates and user authentication in device management.
Machine Learning / Predictive Analytics
Real-time data analysis and anomaly detection for early detection of complications.
Locations
Düsseldorf – Headquarters
DEHeadquarters with development and sales
Düsseldorf – Elisabethstr. 11
DELocation (Creditreform entry)
Industries
Additional services
Reference customers
Quality & Certification
The Niviu System is CE-certified under the MDR and the company operates according to ISO 13485. Practical testing took place in several pilot hospitals with over 1,000 hours of test operation.
| Evidence | Düsseldorf |
|---|---|
| ISO 13485 | |
| CE (MDR) |
History
- 2021
Founding of Elixion Medical GmbH after several years of development and clinical studies on the SmartDrain/Niviu System.