Sense4Baby Cardiotocography System Gets FDA 510(k) and European CE Mark Approval
Dec 6, 2013
Currently, routine checkups for expecting mothers only happen intermittently when the patient is at the doctor’s office. Sense4Baby’s model B+ mobile based cardiotocography system, recently approved for use in both the US and Europe, will provide more flexibility and convenience. The system is currently indicated for non-stress tests with high-risk pregnancies. It comes in a compact kit consisting of the central unit that uses Doppler ultrasound to monitor fetal heart rate, and a pressure sensor to monitor the strength and frequency of uterine contractions. The readings are wirelessly transmitted to a cloud-based HIPAA compliant server, allowing physicians access to observe readings in near real time. The data can also be viewed on a gateway device, either a dedicated smart phone or a web-accessible tablet, for instantaneous analysis.
With the system already deployed in the Netherlands, Sense4Baby is reporting seeing the impact through cost savings and improved convenience for mothers. Although the current system is only approved for use by a trained caregiver, Sense4Baby envisions a future in which mothers can perform self-tests, and is already undertaking development and testing of the system to make this a reality.
Product page: Sense4Baby…