Indications & FDA Status

This page is intended to be educational. It summarizes what is known from published research and ongoing studies. It is not medical advice and does not make promises of benefit. Results vary.

FDA status: The EXOMIND/BTL TMS device is FDA-cleared for Major Depressive Disorder (MDD) only. All other conditions listed are investigational/off-label uses of this device.

What “off-label” means: a treatment approved for one indication is used in another condition based on available evidence and clinical judgment. Off-label use involves uncertainties; not all patients benefit.

† Off-label (investigational)FDA = FDA-cleared indication

How We Present Information

FDA-Cleared

Investigational / Off-Label Indications

Mood disorders

Addictions & cognitive disorders

Sleep, fatigue & pain

Trauma & neurodevelopment

Other off-label indications

Informed-Consent Process

  • All patients receive a written informed-consent form that clearly distinguishes the FDA-cleared indication (MDD) from investigational/off-label uses.
  • The consent covers known and unknown risks, alternatives (including no treatment), and the voluntary nature of participation.
  • We discuss expectations in conditional terms (e.g., “may help,” “has shown potential in studies”).

Safety Program (Summary)

Treatment Responses & Risks

Treatment responses vary. Some patients may not benefit, and this intervention carries inherent risks and uncertainties. Please speak with your physician for individualized assessment.

To learn whether an option may be appropriate for you, please schedule an educational consultation. This discussion is informational and does not obligate you to pursue treatment.

See our Medical Disclaimer for important information about risks, alternatives, and limitations of evidence.

Medical Disclaimer

The information on this site is for general educational purposes only and is not medical advice, diagnosis, or treatment. Reading this site does not create a doctor–patient relationship. Always consult a qualified healthcare professional for personal guidance. If this is an emergency, call 911. Mentions of medications, devices, or procedures are informational and not endorsements. Full medical disclaimer.

Some listed indications involve investigational/off-label use. Learn more.