Will the FDA grant market approval for a brain-computer interface (BCI) with indications for use in able-bodied individuals by 31 December 2030?
Started
Jan 23, 2025 06:00PM
Closed Feb 12, 2025 04:59AM (2 days ago)
Closed Feb 12, 2025 04:59AM (2 days ago)
Brain-computer interfaces (BCIs) are devices that process brain activity and send signals to external software, allowing a user to control devices directly with their thoughts (BuiltIn). BCIs have seen significant advancement in recent years, with companies like Neuralink, Blackrock Neurotech, and Synchron leading their development (MIT Technology Review).
BCIs are primarily being developed for medical applications, including restoring function to people paralyzed by injury or neurological disorders, helping amputees control robotic arms, supporting research into the human brain, and more (U.S. GAO, IEEE EMBS). The U.S. Food and Drug Administration (FDA) has granted breakthrough device designation to several companies and approved limited human trials for BCIs.
Notable developments include:
- Neuralink received FDA clearance for first-in-human clinical trials for its N1 implant, which aims to restore functionality for individuals with neurological conditions, and breakthrough device designation for its Blindsight implant, which aims to restore vision (Neuralink, Reuters).
- Synchron’s Stenrode device received breakthrough designation for allowing patients with severe paralysis to control digital devices through thought (Business Wire).
- Onward Medical’s ARC-BCI system, aimed at restoring mobility after spinal cord injuries, was awarded breakthrough designation (Biospace).
The FDA approval process for BCIs involves the completion of rigorous clinical trials and the FDA premarket approval process, since BCIs are likely to be considered high-risk (Class III) medical devices (FDA).
Resolution Criteria:
This is an unscored question that closes for forecasting on 11 February 2025. Although this is an unscored question, we outline the theoretical resolution criteria here.
A "brain-computer interface" refers to a device that creates a direct communication pathway between the brain and an external device through implanted components. For the purposes of this question, the device must be invasive (i.e., implanted in or on the brain). External devices like EEG headsets would not count.
This question would be resolved using FDA announcements, approval documentation (e.g., in the Devices@FDA database), and/or official government or regulatory body press releases regarding the market approval of BCI devices. The device must be approved without restrictions limiting its use to temporary, investigational, humanitarian, or specific medical purposes. The approval documentation must affirmatively indicate usage in able-bodied individuals (i.e., individuals without severe injury or neurological disorder).
This question is part of a series on emerging capabilities in biotechnology and the biomedical sciences.
This question has ended, but is awaiting resolution by an admin.
Possible Answer | Final Crowd Forecast |
---|---|
Yes | 6% |
No | 94% |