What technologies or devices does Neurocept develop and are they FDA-cleared or approved?

1. Missing company in the public documents: why that matters

Neurocept is not named in the selected FDA clearance lists, news pages, or device-approval summaries supplied for this query, so there is no direct evidence in these sources that it has submitted devices for 510(k), De Novo, breakthrough, or PMA review — the FDA release pages and “recently approved devices” index list new clearances and approvals but do not include Neurocept ^{[1] [3]}. The absence from these specific documents does not prove Neurocept has no cleared products; it only shows the provided materials do not mention the company ^{[1] [3]}.

2. How to read FDA public records for device status

FDA public resources include the 510(k) clearance lists and the “recently approved devices” pages that catalog devices shown to be “substantially equivalent” or formally approved; those lists are the standard place to verify whether a device has a 510(k), De Novo, PMA, or other action ^{[1] [3]}. If Neurocept had a recent, prominent clearance or approval within the timeframes of these documents, it would typically be discoverable there. The supplied FDA news-and-updates page is another locus for announcements but again does not mention Neurocept in these search results ^[2].

3. Context on device pathways and what “cleared” or “approved” means

Devices reach the U.S. market mainly via 510(k) clearance (showing substantial equivalence), De Novo classification (for novel low-to-moderate risk devices), or PMA approval (for high-risk devices). The supplied materials explain these pathways and show how FDA catalogs clearances and approvals, underscoring that the correct way to confirm a company’s regulatory status is to consult those FDA listings and supporting documents ^{[1] [3]}.

4. Why some device companies don’t appear in headline lists

Several plausible scenarios explain absence from the provided records: a company may have no U.S. submissions; may have submissions pending or recently filed but not yet reflected in these lists; may market outside the U.S.; or may produce research-stage prototypes rather than cleared products. The supplied sources note that FDA review backlogs and changing regulatory activity can delay public listings — for example, De Novo clearances and novel-device decisions were reported as slowing in 2025, which can affect how quickly new entrants appear on agency pages ^[4].

5. The rising focus on AI/ML devices — relevance to Neurocept’s claims

If Neurocept develops software, AI, or machine-learning-enabled tools for neurology, be aware that recent studies and reporting emphasize that clinical performance data for AI-enabled devices are often incomplete in public filings and that regulatory transparency has been a topic of debate ^{[5] [6]}. JAMA and other analyses referenced here highlight shortcomings in pre- and postmarket reporting for AI/ML devices cleared by FDA — a structural context relevant for evaluating any company’s regulatory claims ^{[5] [7]}.

6. What to do next — steps to verify Neurocept’s regulatory status

The most direct verification route is a search of the FDA device databases (510(k), De Novo, PMA and device registration listings) and the FDA “recently approved devices” pages for the company or its product names; those pages are authoritative for clearance/approval status ^{[1] [3]}. If public FDA records show nothing, request documentation from Neurocept (e.g., a 510(k) number, De Novo summary, or PMA letter) and check for peer-reviewed studies or press releases that cite specific FDA identifiers — the supplied materials show that such identifiers and summaries are what the FDA publishes for cleared devices ^{[1] [3]}.

Limitations and transparency: the sources you provided contain broad FDA lists, news pages, and analyses of AI-enabled device reporting, but none mention Neurocept or its products by name; therefore this piece cannot confirm product types or regulatory status for Neurocept from the supplied documents (available sources do not mention Neurocept) ^{[1] [2] [3] [5]}.