- These digital devices are the basis of Cognoa’s precision health platform.
- The FDA Breakthrough Device Program is envisioned to help patients in receiving timely access to advance technologies.
Cognoa, Inc., the developer of AI-based personalized therapies and digital diagnostics, has reportedly announced that its first digital diagnostic and digital therapeutic devices to treat autism have received Breakthrough Device designations from the United States Food and Drug Administration (U.S. FDA).
Reportedly, these digital diagnostic devices are the foundation of the company’s precision health platform which has been created to support early identification and treatment of pediatric behavioral health ailments.
Chief Executive Officer and Co-founder of Cognoa, Inc., Brent Vaughan was reportedly quoted saying that the company believes in AI-based precision health which can empower parents and the healthcare providers to act on early concerns predictive of developmental delays like autism. The greatest opportunity within the behavioral healthcare sector is to help children and the company is working closely with FDA to support its clinical studies, Vaughan further added.
As per a report published by Associated Press, the FDA Breakthrough Device Program is envisioned to help patients in receiving timely access to advance technologies that have the capacity to provide more effective diagnosis or treatment for irreversibly debilitating or life-threatening ailments. As part of the program, the regulator would provide Cognoa with interactive communication and priority review pertaining to clinical trial protocols and device development, via commercialization decisions.
The Chief Medical Officer of Cognoa, Inc., Dr. Sharief Taraman, M.D. reportedly commented that precious time is lost before the diagnosis of autism as up to three years are likely to pass from the time parents first express concern. The company has been working toward a future where clinicians are better equipped and parents are more empowered to assist children in their progress, Dr. Taraman further added.