FDA Authorizes Novel Medical Devices for Diabetes Monitoring and Migraine Light Sensitivity
The U.S. Food and Drug Administration (FDA) has issued two De Novo marketing authorizations for novel medical devices. Abbott's Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System has been authorized for sale in the United States. This system integrates both glucose and ketone level monitoring into a single device, providing a more comprehensive picture for individuals with diabetes. Additionally, Avulux has received authorization for its precision optical filters, establishing a new medical device classification for managing migraine-associated light sensitivity. These lenses are designed to block specific wavelengths of light (480 nm and 590 nm) that can trigger migraine symptoms, while allowing soothing green light to pass through, and are approved for over-the-counter sale for patients aged 12 or older. 
