AI Medical Devices Surge, But Pediatric Testing Lags Behind

The integration of artificial intelligence and machine learning in medical devices has surged, with the FDA approving nearly 250 such devices by 2023, compared to under 10 in 2013. However, a study from Boston Children's Hospital reveals a significant gap in the pediatric application of these technologies, with only about 40 devices approved for children this year and just 20 percent of them incorporating pediatric data in their algorithms. Researchers Dr. Ryan Brewster and Dr. Florence Bourgeois found that a majority of AI devices were either aimed at adults or lacked specified pediatric use, raising concerns about the safety and efficacy of adult-based algorithms when applied to children.

Opens on Boston Children's Hospital