Landmark achievement brings the company closer to introducing the Bambi Belt System to the European market.
Dutch medtech startup company, 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.
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.
About Bambi Medical and the Bambi Belt
Founded in 2016, Bambi Medical has developed its first product - a wireless neonatal vital sign monitoring system, called the Bambi Belt. The Bambi Belt consists of a disposable Bambi Belt, a reusable Bambi Bridge, and the Bambi Interface. The Bambi Belt functions by being wrapped around the baby’s chest. Sensors integrated inside the belt measure the ECG and dEMG of the baby in a non-intrusive way, while the Bambi Bridge sends the captured data to the Bambi Interface. The Bambi Interface transmits this data to the bedside patient monitor. The system works in combination with existing patient monitors within the hospital infrastructure. The non-sticky and skin-friendly texture of the Bambi Belt eliminates the pain and stress experienced by the babies when using the current monitoring system with adhesive electrodes. Its wireless features allow parents to take the baby out of the incubator and perform Kangaroo Mother Care which, according to the World Health Organization (WHO), is essential for babies' development.
The original concept for the system was created by, now-retired, Pediatrician-Neonatologist at the Maxima Medical Center and Chief Medical Officer of Bambi Medical, Professor Sidarto Bambang Oetomo, MD Ph.D., at the department of Industrial Design at the Eindhoven University of Technology (TU/e).
For product development, Bambi Medical has collaborated with Benchmark Electronics, an electronics company based in Almelo, The Netherlands. Benchmark is also the manufacturing partner of the Bambi Bridge. The company’s manufacturing partner for the Bambi Belt is Freudenberg Medical, a silicone injection molding company based in Kaiserslautern, Germany. The Bambi Interface is manufactured by Sioux Technology Assembly, an electronics company based in Eindhoven, The Netherlands. Bambi Medical closely collaborates with the Maxima Medical Center in Veldhoven and the Amsterdam University Medical Center.