Neuralink: A Journey from Founding to FDA Approval – Advancing Brain-Machine Interfaces and Human Enhancement

Neuralink, the neurotech startup co-founded by Elon Musk, has received approval from the Food and Drug Administration (FDA) for its first in-human clinical study.
Neuralink’s brain implant, called the Link, aims to help patients with severe paralysis control external technologies using neural signals, allowing them to communicate and interact with loved ones. The approval marks an important milestone for Neuralink and the broader brain-computer interface (BCI) industry.

A brief history of Neuralink

Founded in 2016 by Elon Musk and a team of seven scientists and engineers, the company initially focused on developing devices to treat brain diseases, with the ultimate goal of human enhancement.
Musk drew inspiration from the concept of “neural lace” in science fiction literature, envisioning a digital layer above the brain’s cortex that could be implanted through a vein or artery. The long-term objective was to achieve symbiosis with artificial intelligence, as Musk considered unchecked AI to be a threat to humanity. He described the device as analogous to a video game, allowing users to resume and upload their previous state and potentially address brain and spinal injuries.

In April 2021, Neuralink made headlines by demonstrating a monkey playing the game “Pong” using its implant. While similar technology had been demonstrated before, Neuralink’s achievement was notable for its wireless design and increased number of implanted electrodes. However, in May 2021, co-founder and president Max Hodak announced his departure from the company. As of January 2022, only two of the eight co-founders remained at Neuralink.

Overall, Neuralink has aimed to push the boundaries of brain-machine interfaces and explore the potential of merging humans with AI. While facing internal challenges, the company continues its mission to develop innovative neurotechnologies.

A nine year old Macaque monkey, plays MindPong with his Neuralink.

What are BCI Brain-Computer Interface devices?

BCIs (brain–computer interface) are systems that interpret brain signals and translate them into commands for external devices. Neuralink is a prominent player in this field, benefiting from Elon Musk’s high profile and leadership. While other companies have developed promising BCI systems, none have obtained FDA approval for a commercial medical device. Neuralink’s approval for an in-human study brings it closer to the market, despite the challenging process of meeting FDA requirements.

What will the future look like for wearable technology?

Neuralink’s BCI devices involves invasive brain surgery, with the Link implant processing and translating neural signals. Thin, flexible threads are inserted directly into the brain tissue to detect these signals. Patients using Neuralink devices will learn to control them through the Neuralink app, enabling them to control external devices such as computer mouse and keyboards via Bluetooth.

The FDA approval is a significant achievement for Neuralink, especially considering recent challenges faced by the company. In February, the U.S. Department of Transportation opened an investigation into Neuralink for alleged mishandling of contaminated hardware. The FDA also reportedly rejected Neuralink’s application for human trials, outlining multiple issues that needed addressing. Moreover, Neuralink has faced criticism from activist groups concerning its treatment of animals during experiments.

BCI devices have the potential to address not only paralysis but also conditions like blindness and mental illness. Musk has expressed Neuralink’s intention to explore these future applications and even stated his personal willingness to receive one of the company’s implants.
Overall, Neuralink’s FDA approval represents a significant step forward in the development and potential market availability of BCIs.

Top Brain-Computer Interface Companies Shaping the Future

Non-invasive BCIs do not require direct contact with the brain and use external sensors to detect neural signals. Popular non-invasive techniques include electroencephalography (EEG) and functional near-infrared spectroscopy (fNIRS) and transcranial direct current stimulation (tDCS). Companies like Emotiv, Neurable, and Kernel are leading the way in non-invasive BCI technology. Non-invasive BCIs offer advantages such as lower risk, ease of use, and reduced cost, although they have lower signal resolution, resulting in less accurate communication between the brain and the interface.

This technology, focusing on the development of implantable devices for neuroprosthetics and the treatment of neurological disorders. However, invasive BCIs face challenges such as the risk of infection, surgical complexity, long-term stability, and biocompatibility issues.

Companies at the forefront of BCI technology include:


Pioneering invasive BCI technology, Neuralink is developing an implantable device called the “Link” that enables high-bandwidth communication between the human brain and computers. The company’s initial focus is on treating neurological disorders like epilepsy and Parkinson’s disease.


Kernel specializes in non-invasive BCI technology and utilizes functional near-infrared spectroscopy (fNIRS) to monitor brain activity. They are dedicated to advancing neuroscience and exploring applications in mental health, neurodegenerative disorders, and cognitive enhancement.


Neurable focuses on non-invasive EEG-based BCI technology to enhance human-computer interaction in virtual reality (VR) and augmented reality (AR) environments. Their platform allows users to control digital interfaces using brain activity, providing more immersive experiences.


BrainCo develops non-invasive BCI wearable devices such as the “Focus1” headband. These devices analyze brain activity to improve focus and attention, with applications in education, fitness, and rehabilitation.


Emotiv offers non-invasive EEG-based BCIs that measure brain activity, enabling users to control devices and applications with their thoughts. Their product lineup includes the “EPOC X” and “Insight” headsets, used in various fields such as research, gaming, and accessibility.


OpenBCI supports both invasive and non-invasive BCI research with open-source hardware and software platforms. Their modular products, including the “Ultracortex” headset and “Cyton” board, empower researchers and developers to innovate and collaborate in the BCI domain.


MindMaze leverages BCI technology to create immersive VR experiences for neurorehabilitation. Their non-invasive platform, “MindMotion,” assists in the recovery of stroke and traumatic brain injury patients by utilizing brain activity and motion tracking for motor and cognitive rehabilitation.


CTRL-labs has developed a non-invasive BCI technology called “neural input,” which interprets electrical signals from arm muscles, allowing users to control devices through thought alone. Although it doesn’t directly measure brain activity, this approach provides a novel way to interact with technology without invasive procedures.

Blackrock Neurotech:

Specializing in invasive BCI technology, Blackrock Neurotech designs high-performance neural recording and stimulation systems. Their product range includes the “Utah Array” and “Cereplex” devices, catering to research and clinical applications in neuroscience and neuroprosthetics.

G.tec medical engineering:

G.tec offers various BCI solutions, including both invasive and non-invasive technologies, for research, rehabilitation, and communication. They integrate their technology into medical devices and applications, providing products like the “g.Nautilus” and “g.HIamp” for EEG-based brain-computer interfacing.

A few final thoughts

In addition to the companies mentioned earlier, another non-invasive option in the field of brain-computer interface technology is transcranial direct current stimulation (tDCS). While not a specific company, tDCS has gained attention for its potential in enhancing brain function and facilitating communication between the brain and external devices. As research in tDCS continues to progress, it holds promise for applications in areas such as cognitive enhancement, neurorehabilitation, and mental health. The exploration of tDCS alongside other non-invasive BCI technologies further expands the possibilities for transforming our interaction with the brain and advancing the field of brain-computer interfaces.

The future development of BCI technology will likely involve a combination of invasive and non-invasive approaches tailored to specific applications and individual needs. Advancements in materials, signal processing techniques, and artificial intelligence will contribute to further breakthroughs in this field, revolutionizing our interaction with digital environments and potentially providing transformative solutions for neurological disorders.

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