Regulatory status

What that means in practice

V3LA One reports physiological measurements and produces timing suggestions intended to support general wellbeing and performance. It does not detect, monitor or manage any disease. If you have a sleep disorder, a cardiac condition, or any other medical concern, the right next step is a clinician — not our app.

We deliberately constrain what the product says. It will not tell you that you have a disorder, will not advise you to change a prescribed medication, and will not present its estimates as a diagnostic result.

Safety-critical work

V3LA is not a fitness-for-duty tool. Its impairment forecasts are estimates, they carry uncertainty, and they must not be used to certify that a person is safe to drive, fly, operate machinery or provide patient care. Where an employer deploys the Roster Engine, individual data is never disclosed to the employer and outputs must not be used for disciplinary or fitness-for-duty decisions. That constraint is contractual, not just a policy.

Programs in development

One program on our roadmap — Shift Recovery Rx — contemplates a future clinical indication for shift work sleep disorder. It is at pre-submission stage. It is not cleared, not available for sale, and not being marketed. Nothing on this site should be read as a claim about it.

If that program advances, the regulated version will be a separate product with separate labelling. We will not quietly convert the wellness product into a medical one.

Research use

Devices supplied to research institutions are provided for investigational use in approved protocols only, under a data use agreement, and are not for clinical decision-making. See Publications.

Jurisdictions

V3LA One is offered in the United States at launch. Availability elsewhere depends on local wellness-product rules, and we will not ship into a market where the honest positioning of this product would be non-compliant.