Elon Musk Enters Medical Device Arena: Neuralink's 'Blindsight' Receives FDA Breakthrough Designation

Sep 21, 2024 13:09 CST Updated 13:09

Neuralink

Brain-Computer Interface System Developer

Source | Cyberblue Devices,By| Yueqing

Clinical Applications of Brain-Computer Interfaces Expand Further, Unveiling a New Phenomenal Market in the Medical Device Sector

Elon Musk's Neuralink Brain-Computer Interface Device ReceivesFDA Approval

On September 17, Neuralink, the brain-computer interface company owned by Elon Musk, announced thatIts Blindsight has received the U.S. Food and Drug Administration (FDA) Breakthrough Device Designation.。

Neuralink is a company founded by Elon Musk, located in Fremont, in the suburbs of San Francisco, California, USA. Established in 2016, it focuses on the research and development of brain-computer interface technology.

"Blindsight," which recently received FDA clearance, is Neuralink's second product.Musk stated on social media that,This experimental device, known as “blindsight,” will enable individuals who have lost both their eyes and optic nerves to regain vision. If the visual cortex remains intact, it may even allow those born blind to see for the first time.。

As one of the frontier technologies that has attracted the most attention from the investment community in recent years, the potential of brain-computer interfaces (BCIs) in the medical field has been preliminarily validated. According to McKinsey’s estimates,The potential market size for global medical applications of brain-computer interfaces is expected to reach $40 billion by 2030, and is projected to surpass the $145 billion mark by 2040.。

In May 2023, Neuralink officially received FDA approval to conduct clinical research on its implantable brain-computer interface device in humans. In September of the same year, Neuralink began globally recruiting participants for its first human trial.Last year's financing situation shows that,Neuralink’s valuation has reached as high as $5 billion (approximately RMB 35.3 billion)。

According to statistics from the China Academy of Information and Communications Technology’s “Research Report on the Development and Application of Brain-Computer Interface Technology (2023),” as of the first quarter of 2023, there were more than 500 representative brain-computer interface companies worldwide, distributed across over 40 countries,Among them, the number of enterprises in the United States and China has exceeded 100, ranking in the first tier globally in terms of quantity.。

Source:China Academy of Information and Communications Technology

In addition to Neuralink, the U.S. company Synchron is another industry leader. Unlike Neuralink’s product, Synchron’s brain-computer interface does not require drilling holes in the patient’s skull for implantation,Instead, signal-collecting interfaces are implanted into the blood vessels on the surface of the brain’s motor cortex via the jugular vein, with data transmitted wirelessly through a device located on the chest.。

Recently, Synchron announced that it had successfully connected its brain-computer interface system with Apple’s Vision Pro headset. The company is currently attempting to integrate ChatGPT into its brain-computer system.

China started slightly later in the field of brain-computer interfaces, but has achieved frequent breakthroughs in both clinical research and commercial translation.

In January this year, Tsinghua University announced that its School of Medicine’s brain-computer interface research team had collaborated with Xuanwu Hospital of Capital Medical University in 2023On October 24, [Year], the world’s first clinical trial of a wireless minimally invasive brain-computer interface was successfully conducted.

In August, the Fudan University Center for Neuromodulation and Brain-Computer Interfaces was officially unveiled, dedicated to exploring the principles of neuromodulation and brain-computer interfaces, achieving breakthroughs in disruptive technologies, and advancing healthcare applications.

In terms of industry, domestic enterprises such as Chengyitong, Xiangyu Medical, Sanbo Brain Hospital, and Yanshan Technology are all making in-depth layouts around brain-computer interfaces.

Favorable Policies, but Risks Remain

Driven by its application potential across multiple fields, brain-computer interfaces have received strong policy support in China.

On January 18, the Chinese Government Website released the “Implementation Opinions of the Ministry of Industry and Information Technology and Six Other Departments on Promoting the Innovative Development of Future Industries,” clearly stating thatDevelop high-end medical equipment integrating advanced technologies such as digital twins and brain-computer interaction.

June 13,The National Development and Reform Commission, the Ministry of Commerce, and three other departments jointly issued the "Measures on Creating New Consumption Scenarios and Cultivating New Growth Points for Consumption," proposingPromoting the development of health consumption, which includesR&D of medical equipment and health products integrating technologies such as digital twins and brain-computer interaction。

Financial support is also being intensively advanced, for exampleThe “Action Plan for Accelerating Collaborative Innovation in Medicine and Health in Beijing (2024–2026)” mentions that,By 2026, the total scale of the pharmaceutical and health industry will reach RMB 1.25 trillion, with annual fixed asset investment exceeding RMB 10 billion.includingAccelerate the field of brain-computer interfaces, among othersoutput of results.

Furthermore, in the absence of objective standards and regulations, the early stages of frontier technology development may be prone to chaotic, unregulated growth.

In 2023, the Artificial Intelligence Ethics Subcommittee of the National Science and Technology Ethics Committee compiled the “Ethical Guidelines for Brain-Computer Interface Research,”Research on Non-invasive Restorative Brain-Computer Interfaces, Invasive Restorative Brain-Computer Interfaces, Interventional Brain-Computer Interfaces, Augmentative Brain-Computer Interfaces, and Animal Brain-Computer InterfacesEthical guidelines have been specified for each of the five study types.

According to the current provisions of China's "Medical Device Classification Catalog," brain-computer interface-related devices are primarily classified as Class II and Class III, as detailed below:

Source: Northeast Securities

From a clinical perspective, invasive brain-computer interface devices carry risks of surgical failure and infection, including immune rejection and electrode encapsulation defects. Furthermore, unauthorized access poses a risk of leakage of patients' neural signal data, and there is currently no consensus on the associated social and ethical implications.

According to a research report by Northeast Securities,80% of Brain-Computer Interface Companies in China Have Chosen the Non-Invasive Acquisition Technology Route, for invasive brain-computer interface devices, the vast majority are still in the stages of clinical research and animal experimentation.

However, from technical and market perspectives, invasive brain-computer interfaces target a broader range of medical applications, offering therapeutic solutions for certain clinical challenges that currently lack effective treatments.

At the 2024 Zhongguancun Forum Annual Conference, “Beinao No. 2,” a domestically developed system, made its debut, filling the gap in China’s high-performance invasive brain-computer interface technology and achieving, for the first time internationally, dexterous brain-controlled manipulation of a two-dimensional motion cursor by macaques.

At the current stage, the integration of brain-computer interfaces (BCIs) with clinical practice remains in its early phases. While uncertainties persist regarding large-scale adoption and the final form of future products, the disruptive potential of this technology on existing healthcare systems is already evident. The possibility of creating a phenomenon-level market makes it impossible for the medical device sector to ignore.

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