Has Neurocept received FDA clearance or approval and in what year?

Checked on November 30, 2025
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Executive summary

Available reporting and regulatory databases in the provided results do not show any FDA approval or clearance for a product named “Neurocept.” Consumer complaints and watchdog posts allege Neurocept is not FDA‑approved, and the FDA’s own approval lists and device/approval databases referenced here make no mention of a Neurocept approval or clearance [1] [2] [3].

1. What the sources say — no FDA entry for “Neurocept”

Search results supplied include FDA pages that list approved drugs and devices by year and product (CDER novel drug approvals, drug approvals and databases) but none of those supplied documents or pages include a listing for a product called “Neurocept,” so available sources do not show an FDA approval or clearance for Neurocept [2] [3]. The FDA’s public historic approval listings and the Drugs@FDA/novel approvals pages are the primary official places to confirm approvals; the versions provided in the results do not mention Neurocept [2].

2. Consumer reporting claims Neurocept lacks FDA approval

A Trustpilot review collected in the results explicitly states that Neurocept “is not an FDA‑approved medication” and that the “FDA website does not list any information about a drug or treatment called Neurocept,” calling the product a “scam” in several customer comments [1]. That is a secondary consumer source, not an official regulatory record, but it aligns with the absence of Neurocept in the FDA lists included among the supplied results [1] [2].

3. Where an official confirmation would appear — and what’s missing

Official confirmation of FDA approval or clearance would ordinarily appear on FDA resources cited here: the Novels/approvals pages for CDER drugs and the FDA’s device databases and approval reports [2] [3]. Those resources are cited in the search results provided; none list Neurocept in the excerpts or titles supplied, and no FDA approval documents for Neurocept (e.g., NDA, BLA, PMA, 510(k) entries) are among the supplied results [2] [3] [4].

4. Possible reasons for confusion and the parties involved

The Trustpilot consumer narrative suggests an infomercial and product marketing that claimed FDA approval, and reviewers accuse the marketers of falsely stating Neurocept had “the stringent FDA approval given to pharmaceutical grade products” [1]. Marketing that implies FDA approval when none exists is a frequent driver of public confusion; the supplied consumer report explicitly attributes the claim to the product’s advertising [1]. The supplied official‑looking FDA snippets elsewhere focus on many other approvals across 2024–2025 and do not corroborate any Neurocept listing [5] [6] [7].

5. Limitations of the current reporting

This analysis uses only the search results you provided. Those results include FDA pages and industry coverage of approvals for many other drugs and devices but do not include every page of the FDA website or a complete, live Drugs@FDA search. The absence of Neurocept from the supplied excerpts is strong suggestive evidence that Neurocept is not on those cited approval lists, but it is not the same as running a fresh, comprehensive search of the FDA databases [2] [3]. In short: available sources do not mention an FDA approval or clearance for Neurocept [2] [3].

6. What you should do next to verify definitively

To reach a definitive, official answer beyond the supplied materials, check the FDA’s Drugs@FDA database, the CDER novel drug approvals lists, the FDA device 510(k)/PMA/PMA supplement database, or the FDA search tool directly for the term “Neurocept” or related company names. The documents cited in the search results are exactly the types of sources to consult [2] [3]. If you find an FDA document with Neurocept in a fresh search, that would supersede the current available reporting.

Sources referenced in this piece: Trustpilot consumer report on Neurocept [1]; FDA pages and approval/database overviews cited among results [2] [3]; related FDA/neurology approval roundups in the provided list [5] [6] [7].

Want to dive deeper?
What products does Neurocept make and what are their intended uses?
Has the FDA issued any 510(k) clearance, De Novo, or PMA for Neurocept products and when?
Were there any clinical trials published supporting Neurocept devices and what were their results?
Has Neurocept faced FDA actions, recalls, or safety communications?
How do Neurocept devices compare to competing FDA-cleared neuromodulation technologies?