Bambi Medical Secures CE Mark Approval for Revolutionary ExG System

24 May 2023
The ExG System, a wireless and skin-friendly device developed by Bambi Medical, is specifically designed for continuous monitoring of crucial vital signs in premature infants. This innovative medical apparatus allows for the monitoring of the single lead Electrocardiogram (ECG), Heart Rate, and Diaphragmatic Electromyogram (dEMG), enabling early detection of apnea in newborns. Expressing heartfelt gratitude to the dedicated team and unwavering supporters, Fabio Bambang Oetomo, CEO of the Dutch Bambi Medical, acknowledged their invaluable contributions that led to this remarkable milestone. "Our journey, which began back in March 2016, has been long and challenging. However, I am thrilled and immensely proud of our accomplishment," said Mr. Bambang Oetomo. He marveled at the extraordinary achievement of a small team with limited resources, emphasizing the team's resilience and collaborative spirit that paved the way for success. Despite encountering numerous obstacles during the development, verification, and validation stages, the team's unwavering confidence propelled them towards achieving their goal of bringing the Bambi Belt to the market. Mr. Bambang Oetomo underscored the core purpose of the Bambi Belt, which is to alleviate pain and stress experienced by babies due to conventional monitoring methods employing adhesive electrodes. Moreover, the device aims to foster the bond between parents and their infants. With the attainment of the CE mark, Bambi Medical is now poised to realize its vision of introducing the Bambi Belt to premature babies in hospitals. The company is gearing up for the launch of the Bambi Belt in selected healthcare facilities across the Netherlands, Germany, and Sweden later this year. The CE mark for the Bambi Belt was granted by DNV, the company's designated Notified Body, following successful development and positive results from two clinical trials conducted 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 revolutionized neonatal care with its first product, the Bambi Belt—a wireless neonatal vital sign monitoring system. Comprised of a disposable Bambi Belt, a reusable Bambi Bridge, and the Bambi Interface, this groundbreaking system offers a non-intrusive approach to measuring ECG and dEMG. The Bambi Bridge transmits the captured data to the Bambi Interface, which, in turn, sends it to the bedside patient monitor. Compatible with existing hospital infrastructure, the Bambi Belt's non-sticky and skin-friendly design eliminates the discomfort caused by traditional adhesive electrodes. Furthermore, its wireless capabilities empower parents to engage in Kangaroo Mother Care, a practice endorsed by the World Health Organization (WHO) for optimal infant development. The original concept for the Bambi Belt was conceived by Professor Sidarto Bambang Oetomo, MD Ph.D., a retired Pediatrician-Neonatologist at the Maxima Medical Center and Chief Medical Officer of Bambi Medical. The concept emerged during his tenure at the Industrial Design department of Eindhoven University of Technology (TU/e). Bambi Medical has partnered with Benchmark Electronics, an electronics company based in Almelo, The Netherlands, for product development. Benchmark also serves as the manufacturing partner for the Bambi Bridge. Meanwhile, the Bambi Belt is manufactured by Freudenberg Medical, a silicone injection molding company located in Kaiserslautern, Germany. The Bambi Interface is produced by Sioux Technology Assembly, an electronics company based in Eindhoven, The Netherlands. Bambi Medical maintains close collaborations with the Maxima Medical Center in Veldhoven and the Amsterdam University Medical Center.