Pregnabit system makes it possible to perform CTG examinations anywhere and at any time, especially at home. The Pregnabit system consists of a mobile CTG device and the Medical Telemonitoring Center service, where qualified medical personnel continuously analyze incoming CTG records. Pregnabit is
a device that provides a full medical service that mom can use 24 hours a day, 7 days a week, with no limit on examinations. The Pregnabit mobile CTG can be used by women with a single pregnancy, from 32 week.
The innovation of the project includes the use of a proprietary integrated device based on a microprocessor and a dedicated version of the operating system, which leads to the reduction of the entire system by using more software solutions, simplifying the production stage and speeding up the device’s operation and increasing its reliability. GSM/GPRS/3G communication gives a practically unlimited territorial possibility of transmitting CTG recordings, which consists of recording fetal heart rate with simultaneous recording of uterine muscle contraction activity. The manufacturer assumes the use of medical algorithms that will support the work of doctors, midwives and help to increasingly prioritize the analysis of the performed examinations. In addition, the implemented Bluetooth Low Energy 4.0 module is in line with global trends of “Internet of Things” and gives unlimited possibilities when it comes to expanding the device with additional peripherals and communication with tablets or smartphones.
The Pregnabit system is a combination of a medical product and an IT service, allowing monitoring, ongoing analysis, rapid response and preliminary diagnosis via the Internet. The Medical Telemonitoring Center will serve clients and patients using the mobile CTG. The center will analyze in real time the results of tests performed by pregnant women at home. The center is not only a team of specialized medical personnel, but also special algorithms to ensure additional safety, speed and quality of analysis. Pregnancy management medical staff with access to a dedicated panel on the website will be able to observe in real time the records and analyses of CTG recordings made by the Medical Telemonitoring Center from all patients assigned to the appropriate devices.
The Pregnabit medical device has been classified as a Class IIa product and has undergone a certification process. Notified Body TÜV Nord Poland participated in the process of evaluating the conformity of the product. The assessment ended with a positive result enabling the issuance of a CE Certificate with the number TNP/MDD/0292/4413/2019. The product was placed on the market in 2016 and is still on the market to this day. No medical incident has ever been reported for the Pregnabit medical device, nor has the device been the subject of a suspension and/or recall.
PregnaView, is a component of the Pregnabit system, functioning as a separate medical device, of which Nestmedic S.A. is also the manufacturer.
The medical device has been classified, as a Class IIa device CE Certificate with the number TNP/MDD/0292/4413/2019. The device was placed on the market in 2019 and is still on the market to date. No medical incident has ever been reported for the PregnaView medical device, nor has the device been the subject of a suspension and/or recall.