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.