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Pregnabit – a mobile teleCTG device and its new software have successfully passed recertification audit carried out by TÜV NORD Polska Sp. z o.o. Thus, the company has managed to maintain the CE mark, confirming compliance with the essential requirements set out in Directive 94/42/EEC concerning medical devices. Recently, Nestmedic’s flagship project has been enriched with new functionalities, including real-time examination. Another important step forward is certification of PregnaView CTG visualiser as a new medical device.

The recertification audit of the Pregnabit teleCTG system carried out by TÜV NORD Polska Sp. z o. o. was successful, and so the CE mark for Pregnabit as a medical device was maintained. Nestmedic was also able to maintain ISO 13485 certification – the Quality Management System for Medical Devices. The audit confirmed the company’s adherence to international standards that aim to guarantee the safety and high quality of products, as well as their compliance with legal requirements and customer expectations alike. The Pregnabit device was certified with a new functionality, i.e. real-time examination. The audit also confirmed compliance with the essential requirements set out in Directive 93/42/EEC of a new medical device: PregnaView, which makes an important component of the Pregnabit platform, and is used to visualise CTG records according to medical standards.

Currently, Pregnabit makes it possible to perform CTG tests in real time, which extends the use of the telemedical system as a whole. The device can be used not only by the patient herself at home, but also by doctors and midwives in non-hospital environments. The new functionality has been created to enable CTG examination in locations where access to medical care is difficult and during home births.

We are constantly working to improve our mobile CTG device, Pregnabit – we tune in to the expectations of our customers and implement them in practice. Maintaining CE and ISO 13485 certificates and meeting the requirements set out in European standards for medical devices confirm the high quality and safety of our innovative telemedical products, comments dr n. med. Patrycja Wizińska-Socha, Nestmedic CEO.

Diagnostyka, the largest network of medical laboratories in Poland will manage pilot tests of our mobile CTG device, Pregnabit – a flagship product by Nestmedic. This November, the first Pregnabit devices will reach the selected establishments of Diagnostyka in Cracow. The implementation of the innovative telemedical solution heralds our commercial cooperation with the network. At the moment, Diagnostyka’s offer reaches 15 million patients a year, all over Poland.

Diagnostyka has over 800 facilities in Poland, dedicated to individual patients, and also cooperates with several thousand third-party healthcare facilities, offering over 2500 types of tests. A group that is strongly represented among cooperating professionals comprises gynaecologists and obstetricians.

The pilot implementation of the solution by Nestmedic at Diagnostyka’s laboratories is another important step towards commercialisation of the mobile teleCTG on the domestic market. The Pregnabit system with a dedicated platform for handling and analysing CTG test records will extend the portfolio of the network’s dedicated pregnancy care services. Indeed, pregnant women are an important group of patients for whom Diagnostyka already provides a wide range of tests and services. Remote teleCTG care will be a new and important part of the service proposal.

– The project of implementing the Pregnabit system fits squarely within our vision for the Group development. As the largest network of diagnostic laboratories in Poland, we want to expand our offer with prenatal services for female patients, including in the mobile form. Modern IT solutions that we use for quick diagnosis make it possible for doctors to choose optimal treatment and early prevention approaches. This is the reality that we are building with new generations in mind, says dr hab. n. med. Jakub Swadźba, Diagnostyka CEO.

The combination of Diagnostyka’s wide reach to patients with innovation and mobility provided by the Pregnabit system offers a real chance of improving the quality of perinatal care in Poland. In the parties’ opinion, the introduction of teleCTG to the network of Diagnostyka’s facilities will ultimately exert a positive impact on the availability of CTG examination across the country. It will also let patients borrow Pregnabit devices, including via doctors from smaller facilities and individual surgeries.

– Cooperation with such a large network of medical laboratories as Diagnostyka is a significant step for us in implementing Nestmedic’s development strategy. Diagnostyka’s offer reaches millions of patients a year. It is also addressed to doctors, nurses and midwives, and it employs modern IT solutions, which is invaluable in modern patient care. We are glad that together we can create a comprehensive care system for pregnant women. As we have teamed up with such a reputable partner, we believe that we will be able to abruptly increase the scale of our operations on the Polish market, comments dr n. med. Patrycja Wizińska-Socha, Nestmedic CEO.

The 9^thedition of the conference that connects the world of medicine, start-ups and business: the MEDmeetsTECH medical devices came to an end on 7 November in the Quotation Room of the Warsaw Stock Exchange. One of the speakers was Maciej Stachowiak from Nestmedic. During the session entitled the “Transfer of knowledge”, he answered the question: Can a medical device be managed like a Tesla car? The speech attracted a lot of interest from a large audience. If you want to learn more about the event, please visit:

https://medmeetstech.com/listopad2019