Business · 30/12/2022

FDA Classifies Pediatric Autism Spectrum Disorder Diagnosis Aid into Class II with Special Controls

The US Food and Drug Administration (FDA) is classifying a pediatric Autism Spectrum Disorder (ASD) diagnosis aid into Class II, requiring special controls, to ensure the device's safety and effectiveness. This move aims to improve patients' access to innovative devices, such as those developed by companies like Medtronic (ticker: MDT) and Boston Scientific (ticker: BSX).