MIAMI & MONT-SAINT-GUIBERT, Belgium--(BUSINESS WIRE)--oGabi SmartCare today announced the FDA certification of its digital pediatric solutions. The Belgian medtech start-up will launch the marketing of its connected bracelet specially designed for children aged 0 to 12 and its digital platform in the 2nd quarter of 2024 in the United States. Gabi SmartCare, which has recently signed collaborations with more than 30 American hospitals, aims to become a leader in digital pediatric healthcare.
Gabi SmartCare offers out-of-hospital medical monitoring of newborns and children thanks to its miniaturized monitoring bracelet and digital platform accessible to doctors.
Founded in 2017 and based in Miami (FL) and Belgium, the company is pleased to announce that it has been granted medical certification and permission to market its solutions by the Food and Drug Administration, which regulates the drugs and medical certification in the United States. This certification authorizes Gabi SmartCare to market its full solution, i.e. its connected bracelet, the monitoring of a child's vital parameters as well as its analytical platform, Gabi Analytics, which enables doctors to track a patient's state of health in real time and facilitates remote diagnosis.
Gabi SmartCare's solutions meet a number of key needs: firstly, a credible technological solution that enables better diagnosis and medical monitoring of children; less hospitalization, fewer risks of readmission and continuity of care after hospitalization; greater comfort for patients and their families; and a significant reduction in healthcare costs for both families and the healthcare system as a whole.
For Jonathan Baut, CEO of Gabi SmartCare, "FDA certification of our solutions is the gateway to market our solution in the medical sector. It gives us access to our first high value-added market, the 'hospital at home', where we already have strong traction. We are the only digital pediatric solution that enables home monitoring with remote follow-up, and we want to become the leader in this field."
In October 2023, Gabi SmartCare entered into a partnership with more than 30 hospitals in the United States. 28 of these collaborations involve monitoring children exposed to substances and other environmental, social and biological factors during pregnancy and after birth, in order to study the impact on infant and child development. The medtech start-up has also launched collaborations with 5 other renowned pediatric hospitals, including Children's Mercy (Kansas City) and Columbia University Medical Center (New York).
David Kalfa, Associate Professor of Surgery, Columbia University Irving Medical Center : “1% of newborns are suffering from congenital heart diseases every year and must go through one or several surgeries, sometimes from their first days of life. A close monitoring is required before and after surgery to offer the most optimal care to these babies and children. I am convinced that Gabi SmartCare’s innovative solution offers the very first remote medical device that allows to remotely monitor children with congenital heart defects before, after or in between surgical procedures. Their solution could be a game changer in our field by changing the way that patients are being monitored and cared to optimize clinical outcomes and quality of life.”
From February to December 2022, Gabi SmartCare has conducted a clinical study involving almost 100 children, in collaboration with a number of American and Belgian hospitals. The initial results are very positive: 96% of doctors say that Gabi SmartCare's devices are beneficial for their patients, and 95% believe that having access to the data collected could have prevented certain hospitalizations. What's more, 93% of parents said they were reassured to be able to monitor their children's vital data, and 99% stressed the ease of use of Gabi SmartCare's solutions.
The company is currently working on diagnostic algorithms and intends to develop preventive algorithms using artificial intelligence technologies.
As a next step, Gabi SmartCare is committed to demonstrating the effectiveness of its solution in reducing healthcare costs, following the successful model of similar solutions for adults.
The medtech start-up is planning to raise further funds in the near future in order to accelerate its development. It has raised more than €3 million in April 2021 from Analis, a market leader in scientific instruments and laboratory furniture, and Belgian investors (W.IN.G by Digital Wallonia, NOSHAQ and DGO6 - Direction Générale Opérationnelle de l'Économie, de l'Emploi et de la Recherche du Service Public de Wallonie).
