Periodic Reporting for period 1 - PREGNABIT (PREGNABIT – the world’s first complex telemedical mobile CTG system for pregnancy examination) Reporting period: 2017-02-01 to 2017-04-30 Summary of the context and overall objectives of the project Pregnabit is a small portable medical device, which measures the heart rate of both mother and baby, uterine contractions and tracks foetal movements. In contrast to conventional CTG, Pregnabit can be used in safe home environment without a need to traveling to the hospital.Pregnabit device is part of the complex telemedical system. All the data collected by Pregnabit are transferred to Medical Telemonitoring Centre. Results are immediately checked by a professional gynaecologist who verify the data before sending feedback to the pregnant. Results of every test are available for both the pregnant and her doctor/midwife on the safe web portal.The Pregnabit device is a registered medical device (CE marking) for home CTG testing, available on Polish market. The supporting Medical Telemonitoring Centre is currently working in Poland.The goal of the Feasibility Study was to evaluate the legal, economic and technical viability of introducing Pregnabit on European markets, Spain and France in the first instance. Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far Regulations corresponding to medical devices class II and telemedicine has been studied in Spain and France. Procedures for running the services have been prepared and key partnerships with telemedicine service providers have been established.The updated system architecture, including integration with service providers in targeted countries, has been prepared. The market sizing and segmentation has been evaluated. The total investment required to run the service in targeted countries has been also calculated.The final recommendation from the conducted Feasibility Study is to launch the Phase 2 of the project, which will comprise telemedical service deployment in Spain and France. Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far) The outcome of the project will be a Telemedical CTG service running 24/7 in selected EU countries. Our solution will provide the expecting mothers with immediate information about their baby’s health, and if the medical intervention is necessary, the doctor will be immediately informed. The overall impact of the project will be safer mother and their baby for a lower cost to the healthcare system. Pregnabit device with sensors.
