Nestmedic

Telemedical fetal monitoring · Pregnancy / CTG monitoring

Overview

Pregnabit mobile CTG system enabling remote fetal monitoring; pursuing US/FDA expansion.

What they do

Nestmedic S.A. is a Polish telemedicine company providing the Pregnabit remote fetal-monitoring system. Its current device, Pregnabit Pro, is a mobile cardiotocography (teleCTG) solution that lets pregnant patients perform CTG examinations outside the clinic and transmits the data in real time to the cloud-based Pregnabit Cloud telemedicine platform, where doctors and midwives can review fetal well-being remotely. The system measures fetal heart rate (FHR), uterine contraction activity (TOCO) and lets the patient mark fetal movements. Nestmedic is listed on the Warsaw Stock Exchange.

Lead program & status

The lead product is Pregnabit Pro together with the Pregnabit Cloud platform. The system is CE-marked and the company has maintained certification under the EU Medical Device Regulation (MDR). Nestmedic has pursued US market entry, including FDA clearance ambitions; as of 2024-2025 the device's primary regulatory status is CE/MDR in Europe, and FDA clearance details should be verified against the latest filings. A feasibility study of remote maternal-fetal monitoring using the CE-marked Pregnabit Pro (with ICT Healthcare Technology Solutions) was published in late 2025, supporting its use in high-risk-pregnancy care.

Why it matters

Remote CTG can extend specialist fetal surveillance to patients far from hospitals or in high-risk pregnancies needing frequent monitoring, a model with clear relevance for maternity care in under-served regions.

FAQ

What is Pregnabit Pro?

A mobile teleCTG device that measures fetal heart rate and uterine activity and streams the recording in real time to the Pregnabit Cloud platform for remote review.

Is Pregnabit Pro regulatory-approved?

It is CE-marked and certified under the EU MDR; Nestmedic has also pursued US/FDA expansion, the status of which should be checked against current filings.

Is there clinical evidence for the system?

A feasibility study on remote maternal-fetal monitoring with the CE-marked Pregnabit Pro for high-risk pregnancies was published in late 2025.

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