Neuralink announced that it has received the U.S. Food and Drug Administration’s (FDA) “breakthrough” tag to restore communication for those with severe speech impairment.
An FDA breakthrough device program is designed for “certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions,” the agency’s website explains. The program provides patients and health care providers with “access to medical devices by speeding up development, assessment, and review for premarket approval, 510(k) clearance, and De Novo marketing authorization.”
The brain chip company noted on X that the device will also help those affected by “ALS, stroke, spinal cord injury, cerebral palsy, multiple sclerosis, and other neurological conditions.”
Elon Musk’s Neuralink was approved by the FDA to begin human clinical trials in 2023. The first implant occurred in January 2024. Musk said at the time that the individual was “recovering well.”
The FDA cleared a component of a separate brain implant developed by Precision Neuroscience last month. The company’s Layer 7 Cortical Interface is described as a “high-resolution cortical electrode array” to be used in the “recording, monitoring, and stimulation of electrical activity on the surface of the brain.”
“This is a foundational moment for Precision,” Chief Science Officer and Co-Founder Benjamin Rapoport, MD, PhD, said in a statement. “By introducing the Layer 7 Cortical Interface into clinical settings, we’ll be able to deliver immediate value for patients and neurosurgical teams, enabling real-time neural recording at a fidelity and scale not previously possible.”
