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We are launching operations that allow us to enter the US market. We selected the offer and signed a contract for consulting services in the preparation of a submission 510 (k) (premarket notification), required by the FDA (Food and Drug Administration), the US administration issuing authorizations to introduce, among others medical devices for the US market.

The selected consulting company will provide professional advisory services in the field of preparation of comprehensive documentation, including a 510 (k), allowing for obtaining permission to start the mobile CTG Pregnabit distribution on the US market.

The US market has a very large potential for the telemedical solution such as CTG Pregnabit. It is at the forefront of the largest markets in the world, where 4.32 million births are recorded every year and the world’s largest eHealth service market, estimated at 3.82 billion dollars.

– The selected adviser will help us in preparing and submitting to the FDA in the first half of next year a suitably prepared 510 (k), which is a simplified procedure based on similar solutions already existing on the market. Completing the procedures and obtaining the FDA permit will allow us to enter Pregnabit teleCTG into the US market at the turn of 2019/2020 – comments Patrycja Wizińska Socha, President of Nestmedic.

The Pregnabit system was created to enable the supervision of pregnancy in the third trimester of its duration, anywhere and anytime. Christmas is coming up. This is a very special time. Thanks to the Pregnabit teleCTG, monitoring of the child’s condition in the womb of the mother can be performed remotely, at the patient’s home, in a tranquil family atmosphere. We share some opinions of mothers who used the Pregnabit system and appreciated its functionality and the sense of security they felt.

There is no place like home. Thanks to you, I spend most of my week at home instead of the hospital

Monika

During the third trimester of my pregnancy, I used the Pregnabit system at my house. This special time happened on Christmas and New Year. The convenience of using the device was especially important to me – I was able to perform a CTG test at my own convenience, without having to go to a midwife or doctor’s office, which could be difficult during the holidays. In addition, together with the family we had the opportunity to listen to the heartbeat of our baby.

Ewa from Wrocław

I rented Pregnabit through upacjenta.pl. I was surprised by the fast response and kindness of the midwife who came to me very quickly and carried out the training. In addition, she was extremely polite and helpful. I felt very safe. CTG gave me the feeling that everything is OK  (umbilical cord was wrapped around the baby). With almost every record, the ladies from the telemonitoring center removed all the doubts. Thank you very much for this sense of security and professionalism.

I recommend it to all mothers, especially those who have an indication for frequent CTG and do not want to spend time before delivery in the hospital.

Justyna

I heartily recommend the Pregnabit device to all future mothers !

Thanks to the fact that I had a Pregnabit device I could leave with my husband for a long weekend in the mountains – despite the advanced pregnancy. I felt calm knowing that in case something disturbs me – I can do a CTG test from any place and at any time, and I will be informed immediately about the result of the examination. The sense of security is also ensured by the fact, that the call center has qualified midwives available 24 hours a day if you have any questions or concerns. In addition, with the help of the device, my husband and I  listened to the heartbeat of our baby – which made us feel its presence and gave us amazing joy

Zuzia’s Mother