FDA has awarded breakthrough designations to several devices and diagnostics for neurological conditions, including an autism test and treatment as well as diagnosis of Parkinson's disease.
Linus Biotechnology received a breakthrough device designation from FDA for a test to help diagnose autism spectrum disorder (ASD). The experimental test, StrandDx-ASD, is designed to detect molecular biomarkers that Linus developed using its exposome and biological response sequencing platform. Using a strand of hair, the test will assess the likelihood of ASD in children up to 18 months of age, and help with the diagnosis of people aged 18 months to 21 years.
The goal is to accelerate the diagnosis of ASD. Currently, physicians rely on behavioral observations and typically diagnose people around 4 years of age. Diagnosis occurs much later in some people, depriving them of the benefits of early intervention.
JelikaLite is working to expand the range of treatment options for young children diagnosed with ASD. FDA granted breakthrough device designation to the company's Cognilum System for the reduction of symptoms of moderate to severe ASD in children aged 2 to 6 years.
The noninvasive device uses LEDs in a headband to deliver infrared light and stimulate the brain. In a study of 30 children with ASD, combining the photobiomodulation therapy with EEG sensors and an AI personalization platform resulted in gains in communication and daily living skills, according to JelikaLite. The therapy is intended to help children integrate into society and have more fulfilling lives.
FDA also awarded breakthrough status to Manus Neurodynamica's Neuro-Motor Pen device for use in the diagnosis of Parkinson's disease. The device is a digital pen that combines sensors with software and analytics to record movements and analyze hand motion. Manus is pitching the output of the device as a way to help physicians differentiate between Parkinsonian tremor and other tremor disorders to enable earlier treatment. The company now plans to agree to a study protocol with the FDA.
ElectroCore is the other recent recipient of a breakthrough designation for a neurological device. FDA awarded the regulatory privileges to its gammaCore non-invasive vagus nerve stimulation device in the treatment of post-traumatic stress disorder. The handheld device delivers mild electrical stimulation to the vagus nerve.
Aside from the neurological space, FDA handed out breakthrough designations to two cardiovascular devices. InterVene received the status for its BlueLeaf Endovenous Valve Formation System, a catheter-based treatment for the failure of venous valves in the legs. BlueLeaf is designed to create valves out of the patient's vein wall tissue, thereby stopping the reflux that causes chronic venous insufficiency. InterVene is evaluating BlueLeaf in an early feasibility study in the U.S.
The other recent cardiovascular disease breakthrough device designation went to Fist Assist Devices for its wearable vein dilation device for end-stage renal disease patients. The Fist Assist Model FA-1 device is designed to promote the creation of arteriovenous fistulas in adults with chronic renal failure whose vein size is likely to be inadequate for the creation of an AV fistula for hemodialysis. Patients wear the intermittent pneumatic compression device on the arm to promote vein dilation.
Finally, Blue Note Therapeutics received breakthrough device designation for a prescription-only digital therapeutic to treat anxiety and depressive symptoms in adults with acute myeloid leukemia who are hospitalized to receive high-intensity induction chemotherapy. The software device, BNT200, provides cognitive behavioral stress management that is synchronized to the four-to-six weeks of chemotherapy some AML patients receive as inpatients.