Background

Neuralink is a tech company developing BCIs (brain-computer interface). In order to bring the device to market, the company requires FDA approval. In Dec 2022, Neuralink created a patient registry that accepted applications for an array of disorders - quadriplegia (paralysis or severe weakness in all four limbs), paraplegia (paralysis in at least two limbs), vision loss, deafness, and aphasia (inability to speak). In May 2023, Neuralink announced that it had FDA approval for a 6 year, in-human clinical study focusing on quadriplegic patients.

According to the Neuralink blog, the study was being conducted under an investigational device exemption (IDE). The FDA IDE approval process [0] requires studies of significant risk devices to

• Submit an IDE application to the FDA (Completed: ???)

• Obtain FDA approval (Completed: May 2023)

• Submit the IDE to the IRB (Institutional Review Board) at each institution where the investigation is to be conducted (Completed: ???)

• Obtain IRB approval (Completed: Sept 2023)

Once the IRB approved the IDE, Neuralink was able to begin enrolling patients in the study. Jan 2024, Elon Musk announced that the device had been successfully implanted in a human.

[0] FDA IDE Approval Process

Market Criteria

Adverse device reactions - Includes death, serious injuries, and malfunctions. Reported adverse effects can be categorized as either anticipated and unanticipated, but the market is specifically interested in unanticipated reports.

Market Resolution

Market will resolve YES if:

• any PRIME study sponsor or investigator reports or records any unanticipated adverse device effects

Market will resolve NO if:

• there are no records or reports of any unanticipated adverse device effects during the PRIME study

• the FDA withdraws approval for any reason other than adverse device effects (e.g., the FDA believes the device is ineffective or scientifically unsound, or that the consent form was inadequate)

Market will resolve N/A if:

• There is some as yet unforeseen flaw with the market design that necessitates cancelling it

Market will resolve based on credible reports of adverse device effects directly stemming from the PRIME study. Credible reports include: FDA media statements, Neuralink media statements, or documents obtained via FOIA. Credible reports do not include: statements from Elon Musk, news articles, or anonymous whistleblowers.

FDA does have confidentiality guidelines surrounding IDE records being released to the public. However, it doesn't look like the confidentiality extends to reports of adverse effects or that it would even apply in this instance. At the very least, adverse effect reports are released at the end of the study. I've quoted the relevant section below[1]:

Confidentiality

Are IDE records released to the public?

FDA will not disclose the existence of an IDE unless:

• FDA determines that the information had been previously disclosed to the public;

• FDA approves a PMA (pre-market approval) for a device subject to an IDE; or

• a notice of completion of a Product Development Protocol (PDP) is in effect.

If the existence of an IDE file has not been publicly disclosed or acknowledged, no data or information in the file are available for public disclosure except for information on banned devices and a report of an adverse effect to an individual on whom an investigational device has been used. [(§812.38)]

Data or information contained in the file is not available for public disclosure before approval of an application for PMA or the effective date of a notice of completion of a PDP. Upon approval FDA will release a summary of the safety and effectiveness data on which the decision was based. Other disclosable information available after the device has been approved includes any protocol for a test or study, adverse reaction reports, and correspondence after confidential information has been deleted. Information available for public disclosure is outlined in 21 CFR 814 Premarket Approval of Medical Devices section §814.9.

[1] FDA IDE FAQs

Note: 31 Jan 24 - added YES-NO-N/A bullet points for clarity

Disclaimer

I do not trade on markets I create in order to avoid motivated reasoning. I've tried to make market criteria as clear as possible, but additional clarification might be needed later. Any significant material changes to the market description will be noted.