Are there clinical trials or FDA approvals related to Neuralink and urinary or pelvic floor disorders as of 2025?
Executive summary
As of the sources in this dossier, Neuralink has FDA authorization to run first‑in‑human clinical trials (the PRIME investigational study) launched in 2023 and expanded through 2024–2025, recruiting people with quadriplegia and related conditions; Neuralink publicly reports multiple human implants and site expansions but specific trials or FDA approvals targeting urinary or pelvic‑floor disorders are not mentioned in the available reporting [1] [2] [3]. Peer‑reviewed critiques and commentary repeatedly note the device’s investigational status and calls for greater transparency about trial registration and indications [4] [5].
1. Neuralink’s regulatory status and human trials: the headline
Neuralink received FDA clearance to begin first‑in‑human testing of its implantable brain‑computer interface (often described as the PRIME study) after earlier setbacks; the company opened recruitment and reports the first implants in 2024 with subsequent site expansions and additional patients in 2025 [1] [2] [3]. Major news outlets covered the initial FDA milestone in 2023, reporting the agency’s acknowledgement of Neuralink’s announcement and noting the device’s investigational classification [6] [7] [8].
2. What the PRIME study is actually testing — indications and participants
Neuralink’s public materials and partner sites describe PRIME as an investigational device study focused on people with quadriplegia from spinal cord injury or ALS; the primary goals reported are feasibility and device‑mediated control of external devices (e.g., robotic arms, cursor control), not specific treatment of pelvic‑floor or urinary dysfunction [3] [1] [2].
3. No explicit mention of urinary or pelvic‑floor disorder trials or indications
None of the provided sources state that Neuralink’s FDA approvals or registered PRIME study target neurogenic lower urinary tract dysfunction, pelvic‑floor dysfunction, urinary incontinence, or related indications. Scholarly reviews of neuroprostheses and Neuralink’s public updates focus on paralysis, speech, vision and device functionality rather than bladder control [9] [4] [1].
4. Broader landscape: BCIs and lower urinary tract dysfunction research
Academic and clinical literature recognize neurogenic lower urinary tract dysfunction as a common sequela of neurological injury, and BCI/neuroprosthetic approaches are discussed in the literature as potential future avenues; however, the present sources do not document a Neuralink study explicitly aiming at those urinary outcomes [9] [5]. Available reporting highlights Neuralink’s early human work in restoring device control and communication, which are plausibly relevant to ADLs (activities of daily living), but a direct trial for pelvic‑floor/urinary therapy is not found in current reporting [1] [4].
5. Transparency, trial registration and critical viewpoints
Scholars and commentators have criticized gaps in scientific dissemination around Neuralink’s early human trials, noting delayed or absent entries in public trial registries and urging peer‑reviewed publication for safety and efficacy claims; those critiques underscore why independent confirmation of any urinary‑focused study would require explicit registry or peer‑review evidence, which the sources show is lacking [4] [5]. News coverage of FDA interaction also emphasizes prior agency concerns and the investigational nature of the device [7] [10].
6. Company claims and reported device ambitions versus current evidence
Neuralink’s public updates and third‑party summaries list ambitious longer‑term plans — multiple BCI systems for telepathy, vision (Blindsight), speech, and deep‑brain indications — and report Breakthrough Device designation for some efforts in 2025; but the cited materials distinguish these as future development tracks rather than current FDA‑cleared indications for urinary or pelvic‑floor disorders [11] [12] [1].
7. What to look for next (how to verify a urinary/pelvic‑floor trial if it appears)
To confirm any future Neuralink study targeting urinary or pelvic‑floor disorders you will need: an official ClinicalTrials.gov registration or equivalent registry entry naming urinary/pelvic‑floor endpoints; an explicit FDA IDE/IDE amendment or other agency documentation citing those indications; or peer‑reviewed trial results describing bladder‑related outcomes — none of which appear in the assembled sources [13] [14] [4].
Limitations and closing note
This analysis is strictly limited to the documents provided. The sources confirm Neuralink’s investigational human trials and site expansion for paralysis‑related indications but do not mention any FDA approvals or registered clinical trials specifically for urinary or pelvic‑floor disorders; available sources do not mention a Neuralink urinary/pelvic‑floor trial [1] [2] [3] [4].