Have regulators like the FDA issued warnings or approvals related to NeuroGold?
Executive summary
Available reporting and regulatory databases in the provided sources do not mention any FDA approval, clearance, warning letter, or enforcement action specifically tied to a product named “NeuroGold.” Searches of FDA warning letters and device approvals in the supplied items instead show activity around other neuromodulation products (for example, Neuromod’s Lenire tinnitus device) and typical FDA decision timelines in 2025 [1] [2] [3].
1. No direct FDA record for “NeuroGold” in the supplied sources
The documents and news items you provided include FDA warning-letter listings, device approval roundups and specific device approvals, but none of those items reference a product or company called “NeuroGold.” The main FDA Warning Letter page and the device databases cited in the search results are the logical places an FDA action would appear, yet the snippets and pages supplied make no mention of NeuroGold [1] [4]. Available sources do not mention NeuroGold.
2. What the supplied sources do show about neuromodulation regulation
The supplied material shows that the FDA actively regulates neuromodulation devices and that approvals and de novo pathways are public and reported—illustrated by Neuromod Devices’ Lenire, which received De Novo FDA approval for tinnitus and is repeatedly documented in the provided sources [2] [5] [6]. That pattern means an FDA clearance or warning for a device named NeuroGold would normally appear in similar sources if it existed [2] [5].
3. Examples of recent device actions and what that implies for verification
Multiple items in your search set demonstrate how the FDA’s actions are covered: trade outlets and company press releases reported Lenire’s De Novo approval and trial basis (TENT‑A3) in detail [2] [7]. Industry previews and trackers list expected PDUFA dates and high-profile decisions, making them plausible places to find regulatory announcements [3] [8]. The absence of NeuroGold from these types of reports in the supplied results suggests there is no publicly reported FDA action on that name in the current set of sources [3] [2].
4. Where a genuine FDA action would appear and how to check
If NeuroGold had an FDA approval, clearance, or warning, it would typically appear in the FDA’s databases (Warning Letters, Devices@FDA) or in trade press and company filings; those exact sources are present among the supplied results and contain other device entries [1] [4]. To confirm outside this dataset, check the FDA’s Warning Letters page and the Devices@FDA database directly and look for company press releases and major trade reporting similar to the Lenire coverage [1] [4] [2].
5. Possible sources of confusion and alternative explanations
The supplied material highlights several reasons a name might not appear: product marketed under a different trade name, a supplement or consumer product not regulated as a medical device, or actions that haven’t been reported yet. The documents show neuromodulation devices receive significant coverage when approved (Lenire) and that FDA action listings and PDUFA calendars are widely reported [2] [3]. Available sources do not mention whether NeuroGold is an alternate brand name, a supplement, or a non‑US product.
6. Limitations and next steps for a definitive answer
This analysis is limited to the search results you provided. Those sources do not mention NeuroGold, so I cannot assert whether NeuroGold has regulatory interactions beyond them: available sources do not mention NeuroGold. To reach a definitive conclusion, consult the FDA’s Warning Letters page and Devices@FDA directly and search newswire and company filings for the exact string “NeuroGold” or its corporate owner; the supplied set shows those are the channels where comparable regulatory actions appear [1] [4] [2].