Is Neurova Academy FDA Approved?

Is Neurova Academy FDA approved?

Neurova Academy is a general wellness and cognitive training program. It is not a medical device, it is not FDA approved or FDA cleared, and it is not offered to diagnose, treat, cure, or mitigate any disease or condition, including concussion, traumatic brain injury, or CTE.

Every clinical director, grant manager, and program officer who looks at us asks this question, so we answer it here in plain words. The rest of this page explains the FDA terms, how to check any product yourself, and where our program sits.

The difference between FDA approved, cleared, and registered

FDA registration is an establishment listing and is not a review of a product's safety or effectiveness. Clearance and approval are product-level determinations.

FDA approval, for a medical device, generally refers to premarket approval, the review FDA applies to the highest-risk devices. FDA clearance generally refers to a 510(k) decision that a device is substantially equivalent to one already on the market. Some novel lower-risk devices receive marketing authorization through the De Novo pathway. Registration and listing tell FDA that a company and its products exist. They are not a finding about whether a product works.

Checking a product's FDA status yourself

You can check a device's status in FDA's public databases. The 510(k) Premarket Notification database lists cleared devices. The Premarket Approval database lists approved devices. The De Novo database lists devices authorized through that pathway. The Establishment Registration and Device Listing database shows which companies and products are registered, which is a separate question from clearance or approval.

General wellness products, as FDA describes them

A general wellness product is a low-risk product intended to maintain or encourage a general state of health or a healthy activity, as described in FDA's guidance General Wellness: Policy for Low Risk Devices. FDA issued a revised version of that guidance in January 2026. Under the guidance, FDA reads a product's intended use from its labeling, advertising, and the other statements a company makes about it. A product that claims to diagnose, treat, cure, or mitigate a disease or condition is outside general wellness, whatever else it says about itself.

Where Neurova Academy sits

Neurova Labs offers Neurova Academy as a general wellness and cognitive training program, designed to support focus, stress regulation, and mental endurance. That is our own determination about our own product. FDA has not reviewed Neurova Academy, and nothing on this page suggests that it has.

The optional RNA gene expression panel we offer is run through iXpressGenes, a CLIA-certified, CAP-accredited laboratory. CLIA certification and CAP accreditation apply to the laboratory's quality and operations. They are separate from FDA device status, and the panel is not used to diagnose any condition.

If Neurova Labs claimed more

If we claimed that Neurova Academy treats, diagnoses, or prevents a disease or condition, it would be a medical device, and it would need the FDA review that goes with that claim. We do not make those claims, and our commitments on what we will not say are in What Neurova Labs Will Not Claim.

Questions for any wellness technology vendor

Ask any wellness technology vendor to state its regulatory status in FDA's own words, then check it.

• Is the product approved, cleared, authorized, registered, or none of these?

• If it is cleared or approved, for what intended use, and what is the FDA number?

• If it is a general wellness product, do the marketing materials make any disease or condition claims?

• If it includes a lab test, which laboratory runs it, and what are its certifications?

To ask us any of these questions directly, write to info@neurovalabs.com.

About Neurova Labs

Neurova Labs is a veteran-led neurotechnology company based in Salt Lake City. Its program, Neurova Academy, is a facilitator-led neuro-immersive brain training program designed to support focus, stress regulation, and mental endurance, with no clinical infrastructure required. Programs can add an optional 22-marker panel measuring RNA gene expression from whole blood, processed by iXpressGenes, a CLIA-certified, CAP-accredited laboratory. Neurova Labs works with military units, first responder agencies, clinics, and community organizations. Learn more at neurovalabs.com.

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Neurova Academy is a general wellness and cognitive training program. It is not a medical device and is not offered to diagnose, treat, cure, or mitigate any disease or condition, including concussion, traumatic brain injury, or CTE. This page describes Neurova Labs' own regulatory position and is not legal advice. References to FDA guidance and databases are for information only and do not imply review or endorsement of Neurova Labs by FDA or any federal entity.

Media contact: Nathaniel Free, chief communications officer, nathaniel.free@neurovalabs.com