What FDA approvals or clearances exist for Neurocept devices as of 2025?

1. No regulatory trail for “Neurocept” in the sources we have

A targeted check of the dataset you supplied finds a commercial/consumer “Neurocept” product review page and a range of FDA device-approval roundups, but none of the provided items record an FDA clearance, De Novo authorization, PMA approval, or Emergency Use Authorization for a company or device called Neurocept ^{[1] [2] [3]}. That absence in the supplied material means we cannot assert that Neurocept has any FDA market authorizations — only that the sources here do not document one ^{[1] [2]}.

2. What the sources do show about similar neurotech approvals in 2024–25

The reporting you provided contains several explicit device authorizations and clearances in the neurology and neurotechnology space during 2024–25 — for example, Precision Neuroscience’s Layer 7 Cortical Interface received FDA clearance for up-to-30-day intraoperative use ^[4], and Epiminder’s Minder won De Novo authorization as the first implantable continuous EEG monitor for epilepsy ^[5]. Practical Neurology’s special reports list multiple 510(k) clearances for brain‑imaging and EEG software/devices, but none of those items in the reporting are tied to “Neurocept” ^{[3] [5]}.

3. One likely explanation: name collision with consumer products

The only explicit “Neurocept” hit in the supplied results is a consumer-oriented review site describing a nootropic supplement or cognitive product — not a medical device — which suggests a branding collision between commercial supplements and regulated medical devices in public reporting ^[1]. That pattern can create confusion: vendors selling supplements or wellness products may use biomedical-sounding names without being subject to device approvals, while legitimate device makers appear in FDA or trade press reporting ^{[1] [4]}.

4. How reliable sources normally show FDA device actions — and what’s missing here

When a device receives FDA clearance or approval, the event appears in the FDA database and is picked up by trade outlets (NeurologyLive, MedTech Dive, Practical Neurology, Fierce Biotech) and company press releases; the supplied corpus includes many such stories for other firms ^{[2] [4] [3] [6]}. None of the supplied trade or regulatory summaries that catalog 510(k), De Novo, or PMA decisions mention Neurocept, which in typical journalistic practice is a strong indicator that no documented regulatory action for that name appears in these reports ^{[2] [3] [4]}.

5. Limitations and what is not found in current reporting

My review is limited to the search results you provided. Available sources do not mention an FDA approval, clearance, De Novo authorization, PMA, or EUA for a Neurocept medical device as of 2025 ^{[1] [2] [3]}. These sources also do not say whether Neurocept has pending submissions, is referenced under a different corporate name, or holds state-level or foreign approvals — those possibilities are not covered in the supplied material ^{[1] [2]}.

6. What you should do next to verify rigorously

To confirm definitively, consult the FDA’s publicly searchable device databases (510(k), De Novo, PMA) and the company’s official filings or press releases; trade outlets and Practical Neurology/NeurologyLive regularly flag new device actions and would report a Neurocept clearance or approval if it existed in the regulatory record supplied here ^{[3] [2]}. If you want, I can re-run searches against the FDA databases and broader press if you supply additional links or allow me to use other sources beyond the set you gave.