FDA has awarded breakthrough Designations to several devices and diagnostics associated with neurological conditions. Also, the FDA has awarded breakthrough Designations to autism test and treatment as well as diagnostics for Parkinson’s disease. Linus Biotechnology, received breakthrough designation for its test called StrandDx-ASD, that will help diagnose autism spectrum disorder (ASD). The test will assess the likelihood of ASD in children up to 18 months of age to 21 years age young adults.
Currently, there are no diagnosis test that can detect ASD in younger depriving them of the benefits of the treatment. With the breakthrough designation for the new test, the healthcare community can assess ASD at earlier age and expand its treatment options for younger children diagnosed with ASD. Moderate to severe symptoms of ASD can be treated with the new autism test.
The device is handheld and gives stimulation to the vagus nerve. Furthermore, breakthrough Designations have been awarded to two cardiovascular devices, InterVene and Fist Assist Devices.Finally, Blue Note Therapeutics has also received breakthrough designation from FDA. Blue Note Therapeutics treats symptoms of anxiety and depression and is available only after prescription by licensed health expert.