A medical start-up setting out to conquer the American market


A Belgian start-up is multiplying its partnerships across the pond, with a highly promising device that enables better monitoring of sick young children outside the hospital environment.

Gabi SmartCare is a start-up from Mont-Saint-Guibert (Walloon Brabant province), founded in 2017.

The medical device designed by this Belgian company enables monitoring of various vital medical parameters, such as blood oxygen levels and heart rate, in infants and very young children outside the hospital environment. Comprising a band worn on the upper-arm, and connected to a mobile application assigned to parents, the device is linked to a digital platform providing doctors with dashboards for rapid interpretation of the data collected from children.

By 2022, the Belgian medtech company had already carried out an initial, highly conclusive clinical study in collaboration with four hospitals (two in Belgium and two in the United States). The study yielded very positive results from doctors and parents of almost 100 young children.

In 2023, Gabi SmartCare expanded its partnership to some 30 American hospitals. However, in order to consider marketing its device on a larger scale, the Belgian start-up needed to obtain medical certification from the Food and Drug Administration (FDA), which regulates the marketing of medicines and medical devices in the United States.

At the start of 2024, with doors opening now they have the American FDA in their pocket, the Belgian entrepreneurs are now looking to raise 5 million euros in funds to establish a more permanent foothold across the Atlantic.

In future, the medtech company is also planning to equip its connected band with artificial intelligence capable of predicting medical risks in very young children, as well as monitoring and analysing data.

A great Belgian success story!