What FDA is—and is not—doing: Co-sponsoring a scientific workshop is not an FDA clearance, approval, endorsement of a commercial clinic or announcement that focused ultrasound treats depression, OCD, schizophrenia, autism, or another psychiatric diagnosis.
FDA's preliminary agenda (all times Eastern)
The FDA published this schedule as preliminary and subject to change. The agenda spans low-intensity neuromodulation, patient risks, how clinical studies should measure benefit, nonclinical safety, and a separate discussion of blood-brain barrier opening.
9:00–9:15 a.m. ET
Opening and introduction
Event goals and welcome
9:15 a.m.–noon ET
Session 1 — Neuromodulation
Clinical outcomes, mechanisms, patient risks, real-time monitoring, feasibility versus pivotal clinical studies
Noon–1:30 p.m. ET
Lunch break
No formal workshop session
1:30–2:00 p.m. ET
Session 2 — Nonclinical safety
Verification and validation of safety for transcranial ultrasound
2:00–4:45 p.m. ET
Session 3 — Blood-brain barrier opening
Applications, microbubbles, monitoring, liquid biopsy, oncology, gene therapy, neurological and pediatric considerations
4:45–5:00 p.m. ET
Closing remarks
Wrap-up
Registration, webcast and accessibility
Registration is free for both virtual attendance and in-person attendance at the Hilton McLean Tysons Corner in McLean, Virginia. It is first-come, first-served, and in-person seating is limited. FDA lists the deadline as November 5, 2026 at 4 p.m. Eastern. Registration is completed using the form on the official FDA page, not through NeuroCoach.
FDA will email the webcast link to registered virtual attendees before November 10. The agency says an archived webcast will be posted to its workshop webpage after the event; do not assume a recording is already available.
For registration questions or disability accommodation requests, the FDA lists CDRH-OPEQ-StrategicInitiatives@fda.hhs.gov and 301-796-4322 as contacts. Check the FDA's official event page before making arrangements in case the schedule or registration details change.
What should NeuroCoach readers look for after the workshop?
- Specific psychiatric indications: Does new evidence actually evaluate depression, OCD, schizophrenia or another diagnosis, or does it concern different neurological uses?
- Safety details: How are acoustic exposures, targeting, patient risks and real-time monitoring addressed, including pediatric considerations?
- Quality of studies: Are there controlled trials with meaningful outcomes and longer follow-up, or only early feasibility studies?
- Regulatory status: Did the FDA issue a separate formal device decision or guidance, rather than a panel discussion or investigator suggestion?
- Public materials: Check the FDA event webpage for the archived webcast or subsequent published resources. Workshop discussion alone is not a new clinical recommendation.
What is transcranial focused ultrasound?
Specialized equipment aims sound waves at selected areas of the brain through the skull. The term covers distinct technologies with very different goals, intensities and risks. They should not be treated as interchangeable.
Low-intensity ultrasound neuromodulation
Researchers are investigating whether carefully targeted sound energy can temporarily influence neural activity without an implanted electrode. Psychiatric applications are early-stage research, with questions about optimal targeting, dose, durability and reproducibility.
Blood-brain barrier opening
Some experimental protocols use ultrasound with microbubbles to temporarily increase access across the protective barrier around brain blood vessels. This is a different intervention from direct neuromodulation, and carries distinct safety and monitoring questions.
High-intensity therapeutic ultrasound
Other uses intentionally create localized thermal or tissue effects for particular neurological applications. A regulatory authorization for one device or condition does not establish safety or effectiveness for psychiatric use.
TMS and DBS are different
Transcranial magnetic stimulation uses magnetic pulses, while deep brain stimulation usually requires implanted electrodes. Each technology has its own evidence, specific indications and risks. Do not assume a result with one applies to another.
Explore TMS evidence →How strong is the evidence for psychiatric treatment?
A 2026 scoping review of clinical focused-ultrasound neuromodulation studies found early signals across some psychiatric disorders, but only a subset came from positive randomized trials; many were small or uncontrolled. Protocols, targets and follow-up varied substantially. This is not a solid basis for routine clinical use across diagnoses.
The FDA workshop may help standardize what researchers must measure and report. It does not itself supply new patient outcome data or change treatment recommendations.
Questions to ask if a clinic advertises ultrasound for a psychiatric condition
- What is the exact technology and intended condition: neuromodulation, brain tissue ablation, or blood-brain barrier opening?
- Is the device authorized for this specific use in my country, or is the intervention investigational or off-label?
- Is there a registered trial, an ethics review, a qualified medical team and a published safety-monitoring plan?
- What benefits were demonstrated in controlled human studies, and how long were participants followed?
- What are the costs, risks and evidence-based alternatives available now?
For people experiencing active psychosis, mania, severe depression or rapidly worsening symptoms, timely assessment by an appropriate clinician should take priority over pursuing experimental neuromodulation.
Primary sources and editorial status
- FDA — November 10, 2026 research roundtable, objectives, agenda and registration
- 2026 peer-reviewed scoping review of focused ultrasound neuromodulation in psychiatric disorders
- NIMH — Brain Stimulation Therapies overview
Reviewed October 16, 2026. Status refers to psychiatric applications discussed here, not all medical uses of ultrasound. This is educational content; independent clinical review pending. Check the FDA page for event changes.