On 25 May 2023, Neuralink tweeted
IANAD, but my understanding of this FDA rule, then Neuralink or an affiliated group is required to register a study on clinicaltrials.gov for their neural implants...but I can't find the study. This could be (in order of likelihood) because I am bad a searching for clinical trials, because the study is registered in a different database, because I've misunderstood the FDA and Neuralink is not required to register their study, or because Neuralink PR smoked the good kush that day.
Mana to whoever links the registered study (from any database) OR provides a credible explanation for why the study wouldn't be publicly registered.
The results of this bounty will help determine the outcome of this market
FWIW, https://neuralink.com/blog/first-clinical-trial-open-for-recruitment/ states “The PRIME Study is being conducted under the investigational device exemption (IDE) awarded by the FDA in May 2023”, and according to the FDA (https://www.fda.gov/medical-devices/investigational-device-exemption-ide/faqs-about-investigational-device-exemption#sites): “At this time, FDA does not maintain a clinical trials database for medical devices and our regulations do not permit us to release information regarding investigational devices. However, the National Institutes of Health maintains a clinical trials database for trials that they support. It may be accessed through the Internet at ClinicalTrials.gov.” [emphasis added].
Speculating: as there’s no claims of NIH support/approval/etc and they have a private Patient Registry, it’s possible they fall under the part of the linked rule that reads: “excluding small clinical trials to determine feasibility and certain clinical trials to test prototype devices”
Study is not publicly registered, will be conducted with the Barrow Neurological Institute.
I think it might be exempt. Neuralink's Humanitarian Device Exemption was approved in 2002. Maybe it's still in effect. chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.accessdata.fda.gov/cdrh_docs/pdf/H010004A.pdf
so many brain interface studies
There are some issues with their (and other databases), Wikipedia says "problems of the concordance between the ClinicalTrials.gov record and the published record have been identified for many protocol and results items". I've tried the WHO's search and can't find it either: https://trialsearch.who.int/