Elon Musk’s brain implant company Neuralink has just received approval from US regulators to finally commence testing its innovative device in people. The venture took to Twitter to make the announcement, although specific details about the study have not been disclosed and it is not yet listed on the official US government database of clinical trials.

While the Food and Drug Administration (FDA) officials neither confirmed nor denied granting the approval, FDA press officer Carly Kempler mentioned in an email that the agency “acknowledges and understands” Neuralink’s announcement.

We are excited to share that we have received the FDA’s approval to launch our first-in-human clinical study!

This is the result of incredible work by the Neuralink team in close collaboration with the FDA and represents an important first step that will one day allow our…

— Neuralink (@neuralink) May 25, 2023

Neuralink is among several groups dedicated to developing interfaces that connect the nervous system with computers — these efforts aim to revolutionize the treatment of brain disorders, overcome brain injuries, and explore various other applications.

Just recently, researchers in Switzerland published a breakthrough study in the journal Nature, showcasing an implant that successfully restored communication between the brain and spinal cord, enabling a paralyzed man to stand and walk naturally.

Currently, there are over 30 ongoing clinical trials related to brain-computer interfaces and spinal cord interfaces, according to clinicaltrials.gov.

Currently, there are over 30 ongoing clinical trials related to brain-computer interfaces and spinal cord interfaces, according to clinicaltrials.gov.

Elon Musk, who also owns Twitter and serves as CEO of Tesla and SpaceX, mentioned in December of last year that his team was in the process of seeking regulatory permission for Neuralink’s device testing. The device (about the size of a large coin) is designed to be implanted in the skull with ultra-thin wires directly connecting to the brain.

Musk has outlined the initial applications in humans, aiming to restore vision and assist individuals with limited muscle control to operate digital devices more efficiently. Additionally, he envisions bridging brain signals to Neuralink devices in the spinal cord to aid those with spinal injuries.

Elon Musk presenting Neuralink on stage. (Image: “Elon Musk and the Neuralink Future” by jurvetson)

Following Musk’s presentation on the device, Rajesh Rao, co-director of the Center for Neurotechnology at the University of Washington, commented that Neuralink may not be ahead in terms of brain-computer interface achievements, but their hardware is notably advanced.

While the ultimate effectiveness and safety of this device and similar interfaces remain uncertain, it’s important to note that Neuralink’s interface is currently classified as an “investigational device.” Clinical trials will provide crucial data on its safety and efficacy.

Neuralink clarified in their recent tweet that they are not yet recruiting participants for the study, but they promise to share further details soon. Stay tuned for more updates on this remarkable endeavor!

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