Awards & Certifications

Bambi Medical receives the CE mark for the ExG System


Bambi Medical, announced today that it obtained the CE mark for the main component of its skin-friendly and wireless neonatal vital sign monitoring device - the ExG System. Landmark achievement brings the company closer to introducing the Bambi Belt System to the European market.

This medical device is intended to be used for continuous monitoring of the single lead Electrocardiogram (ECG), Heart Rate, and Diaphragmatic Electromyogram (dEMG) for enabling apnea detection in premature babies.

The CEO of the company, Fabio Bambang Oetomo, expressed gratitude to the team and all the supporters of the company for their contribution to achieving this milestone. “It has been a long journey, longer than I expected when I started the company in March 2016, but I am extremely happy and proud of this achievement,” said Mr. Bambang Oetomo. I think it is amazing how a small team with limited resources, was able to achieve such a big thing, despite the challenging times. This says a lot about the resilience and good collaborative spirit that we have within the team. We have gone through huge ups and downs both in the development process and during verification and validation, but the confidence always remained that we would be successful in getting the Bambi Belt to the market.”

Mr. Bambang Oetomo highlighted that the Bambi Belt was invented to reduce pain and stress for babies (which is caused today by the adhesive electrodes of conventional monitoring) and facilitate bonding between parents and babies. By obtaining this CE Mark, the company is closer to realizing its goal of bringing the Bambi Belt to premature babies in hospitals – the company is preparing to introduce the Bambi Belt in selected hospitals in the Netherlands, Germany, and Sweden later this year.

Bambi Belt obtained the CE mark from their Notified Body DNV, after the successful development and the positive results from two clinical trials held at the Amsterdam University Medical Center (Amsterdam UMC) and the Maxima Medical Center (MMC) in Veldhoven

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