Florida State University (FSU) and Sky Therapeutics have secured U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for Cenextra, a digital therapy designed to improve executive functioning in children with attention-deficit/hyperactivity disorder (ADHD).
The designation highlights the technology’s potential to address an important unmet clinical need while benefiting from an accelerated regulatory review process.
Cenextra is the first digital ADHD therapy to receive the FDA’s Breakthrough Device Designation.
The treatment delivers patented cognitive training through arcade-style video games, including puzzles, adventures and problem-solving activities, to help strengthen planning, organisation and self-regulation skills.
The therapy was developed at FSU’s Children’s Learning Clinic and evaluated in two controlled clinical trials supported by $3 million in funding from the National Institutes of Health (NIH).
The FDA based its designation on evidence generated from these studies. Additional clinical trials are currently underway with a further $9 million in NIH funding to expand the clinical evidence supporting the technology.
While the designation does not represent FDA approval or clearance for commercial use, it provides access to the agency’s Total Product Lifecycle programme, allowing closer collaboration with regulators and a prioritised review pathway.
Sky Therapeutics will continue the clinical and regulatory development of Cenextra with the goal of bringing the non-drug digital therapy to children and families across the United States.
