FDA De Novo Listing Adds BrainScope Ahead 100 to the Agency’s Novel Device Registry
The FDA’s De Novo database lists BrainScope Ahead 100, a device from Brainscope Company, Inc., under De Novo number DEN140025 with a decision date of 11/17/2014. In the agency’s classification system, the De Novo route is reserved for devices reviewed under Section 513(f)(2), a pathway used for novel technologies that do not fit neatly into an existing classification category.
The registry entry is brief, but its placement inside the De Novo database carries regulatory weight. A De Novo listing means the device has been evaluated as part of the FDA’s process for new medical technologies, rather than being handled through the more familiar premarket clearance framework tied to predicate devices. For clinicians, hospital systems, and device reviewers, that distinction matters because it signals a device that entered the market through a classification route designed for novelty rather than direct comparison to an established predecessor.
The record itself supplies only the core identifiers: the device name, the requester, the De Novo number, and the decision date. No performance data, clinical claims, or indication language appear in the scraped page. Even so, the database entry is clinically relevant because it marks the device’s formal place within FDA oversight and creates a traceable regulatory record that can be cross-referenced in procurement, compliance, and postmarket review workflows.
A De Novo classification is especially important when a device is new enough that the agency has no obvious predicate to anchor risk assessment. In practical terms, the pathway is designed for technologies that are sufficiently different from prior devices to require their own classification. Once that classification is established, the device can sit within a defined regulatory category rather than remaining permanently outside the system. For the medical community, this is how a novel tool becomes legible to regulators, institutions, and eventual users.
The decision date of November 17, 2014 places BrainScope Ahead 100 among the earlier entries in the public De Novo archive visible on this page. The surrounding records on the same screen show that the database is organized as a searchable catalog of device names, requesters, De Novo numbers, and decision dates. That structure may appear administrative, but it is the backbone of transparent device regulation. It allows reviewers to identify when a product was classified, which company submitted it, and how it was indexed in the federal record.
A single registry line cannot answer the clinical questions that usually matter most at the bedside. It does not tell physicians how the device performs in a trial, whether it changes diagnosis, what patient population it was designed for, or how it compares with standard care. Those details live elsewhere, in device summaries, labeling, and any supporting evidence package tied to the classification decision. What the listing does establish is simpler and still important: BrainScope Ahead 100 reached a formal FDA De Novo decision and was assigned a specific regulatory identity.
For health systems, that regulatory identity can influence how a product is reviewed by purchasing committees, biomedical engineering teams, and compliance staff. A device listed through De Novo is not merely a commercial product; it is a technology that has passed through a pathway built for devices without a ready-made predicate classification. That makes the FDA record a starting point for downstream evaluation, not the end of the conversation.
The same page also shows the broader structure of the database, with adjacent entries for other devices and separate pagination across the De Novo archive. This reinforces the fact that the public FDA record is not a narrative article or a clinical study report. It is an index of regulatory outcomes. Even so, each line in that index represents a concrete federal action, and the presence of BrainScope Ahead 100 in that catalog is the specific takeaway from the source material.
Because the scraped page offers no description of indication, accuracy, safety, or intended use, no additional clinical conclusions can be drawn here. The only supportable statement is that the FDA’s De Novo database includes BrainScope Ahead 100, tied to Brainscope Company, Inc., under DEN140025, with a decision date of 11/17/2014. For anyone tracking device regulation, that is the anchor point from which all further review would begin.