Gabi SmartCare Wins FDA Nod for Digital Pediatric Solutions

Gabi SmartCare has gained U.S. Food and Drug Administration (FDA) certification of its digital pediatric solutions.
 
The Belgian startup will begin marketing its connected bracelet for children aged 0-12 and digital platform in Q2 2024 in the U.S. The connected bracelet monitors a child’s vital parameters and its Gabi Analytics platform lets doctors track the patient’s state of health in real-time, and facilitates remote diagnosis.
 
The company said its solutions offer a credible tech solution for better diagnosis and monitoring of children, less hospitalization, fewer risks of readmission and care continuity after hospitalization, comfort for patients and families, and reduction in healthcare costs for families and the healthcare system.
 
“FDA certification of our solutions is the gateway to market our solution in the medical sector,” said Jonathan Baut, CEO of Gabi SmartCare. “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, the company began a partnership with over 30 U.S. hospitals. 28 of the collaborations entail monitoring children exposed to substances and other environmental, social, and biological factors during pregnancy and after birth, in order to study impact on infant and child development.
 
From February to December 2022, Gabi SmartCare conducted a clinical study involving nearly 100 children, collaborating with a number of American and Belgian hospitals. The initial results are very positive: 96% of doctors said Gabi SmartCare’s devices are beneficial for patients, and 95% believe having access to the data collected could have prevented certain hospitalizations. 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 said it intends to develop preventive algorithms using artificial intelligence technologies.