E!11421 IMPROVE - Neosense Technologies
| Reference number | |
| Coordinator | NEOSENSE TECHNOLOGIES AB |
| Funding from Vinnova | SEK 3 801 136 |
| Project duration | September 2017 - December 2020 |
| Status | Completed |
| Venture | Eurostars |
Purpose and goal
The purpose of the project is to monitor arterial oxygen tension to improve the oxygen therapy for critically ill and preterm babies. The aim of the project is to develop a medical monitoring system composed of a monitor and a customized umbilical catheter. The umbilical catheter is equipped with two electrodes for measuring oxygen tension and a thermocouple for measuring body temperature. Monitor and catheter are two different products that are connected as a combined medical device. Both products must obtain the CE mark in order to be approved within the EU.
Expected results and effects
Both the monitor and the umbilical catheter are today fully developed products. We are currently conducting a clinical investigation where our system is used clinically on designated patients to evaluate its essential performance and safety. After the clinical trial, a review of all project documents remains in order to CE - mark the products. The review is performed by our Notified body.
Planned approach and implementation
The project work has been carried out by Neosense Technologies as project lead, and MedFact engineering as a partner in the consortium. Neosense has developed the monitor including software and measurement electronics, while MedFact has developed the umbilical catheter. Both products have been developed in compliance with the medical standard ISO 13485. Neosense is the legal manufacturer of both the monitor and the catheter and will thus be responsible for both sales and marketing of both products.