Nestmedic has started the PregnaOne System certification process before the Amercinan FDA

Nestmedic has formally launched the PregnaOne System certification process, which consists of the Pregnabit Pro device and the Pregnabit Cloud platform in the US before the US Food and Drug Administration (FDA) as a result of submitting a Pre-Submission. to the FDA, the company said.

“Obtaining the FDA certificate is another of the challenges currently facing the company. The FDA certificate will enable the issuer to start selling PregnaOne System in the USA, which is one of the largest markets for medical devices in the world, and thus will enable the company to continue its dynamic development, including acquiring new contractors and investors and achieving the company's goals "- reads the release .

Nestmedic, established in 2014, is a Polish brand from the medtech industry, whose flagship product is the Pregnabit system, used for remote CTG testing for pregnant women. Nestmedic debuted on NewConnect in 2017.

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