SKY THERAPEUTICS, FLORIDA STATE UNIVERSITY ANNOUNCE FIRST FDA BREAKTHROUGH DEVICE DESIGNATION FOR ADHD TREATMENT

TALLAHASSEE, Fla., July 13 -- Florida State University issued the following news release:

Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) is granted for new technologies that have real potential to improve outcomes and should get priority attention. Most new devices fail to attain this status, as the majority of applications are denied.

However, a digital ADHD treatment developed by a Florida State University team achieved the coveted breakthrough designation status.

Developed at FSU and licensed by the startup Sky Therapeutics, Cenextra is the first ADHD treatment to receive Breakthrough Device designation, reflecting its potential to address a growing public health concern. Cenextra uses a patented seri...