FDA and the Focused Ultrasound Foundation are co-sponsoring a hybrid public workshop — , 9 a.m.–5 p.m. ET, at the Hilton McLean Tysons Corner in McLean, Virginia, with a virtual option — bringing researchers, clinicians and device developers together on the scientific and regulatory path for transcranial ultrasound in neurological and psychiatric applications.
Dates and format
- Date: 10 November 2026, 9 a.m.–5 p.m. ET
- Format: hybrid — in person at the Hilton McLean Tysons Corner, or virtual via a webcast link emailed to registered attendees before the event
- Registration deadline: 5 November 2026 for both in-person and virtual attendance
- Organizers: FDA, co-sponsored with the Focused Ultrasound Foundation
What it covers
The roundtable format puts FDA reviewers alongside outside researchers and clinicians to work through the evidence base for transcranial ultrasound — a technology moving from investigational use into a growing pipeline of neurological and psychiatric indications. Named topic areas include safety considerations and patient risks, nonclinical assessment approaches, clinical trial design and outcome assessments, and the needs of special populations, including pediatric patients. An archived webcast is posted after the event for anyone who cannot attend live.
Who should attend
Regulatory and clinical leads at device sponsors developing transcranial or focused-ultrasound technology, nonclinical and clinical scientists building a safety and efficacy evidence package, and biostatisticians working on trial design for neurological or psychiatric device endpoints. The pediatric-populations topic also makes this relevant to sponsors weighing a pediatric extrapolation or study plan early.
Tracking other CDRH workshop and advisory activity this quarter? FDA's Microbiology Devices Panel meets in November and FDA's robotic medical devices workshop runs in December; the full events directory lists everything we have verified.
Frequently asked questions
How do I attend the FDA transcranial ultrasound workshop?
The workshop runs 10 November 2026, 9 a.m.–5 p.m. ET, hybrid at the Hilton McLean Tysons Corner in McLean, Virginia, with a virtual option. Registration for both in-person and virtual attendance is open through 5 November 2026; virtual attendees receive a webcast link by email before the event.
Is there a fee to attend?
No registration fee is stated in the organizer's announcement. FDA public workshops are typically free, but this should be confirmed on the FDA event page's own registration section before relying on it.
What does the agenda cover?
FDA and the Focused Ultrasound Foundation have named broad topic areas: safety considerations and patient risks, nonclinical assessments, clinical trial design and outcome assessments, and special population needs including pediatric patients. A detailed, timed agenda was not published in the sources reviewed.
Sources & further reading
- FDA. FDA and the Focused Ultrasound Foundation Co-sponsored Public Workshop: Research Roundtable on the Development of Transcranial Ultrasound for Neurological and Psychiatric Applications, 11/10/2026. fda.gov
- FDA. CDRH Events — upcoming meetings and workshops. fda.gov
Event details are published by the organizer and can change. Confirm dates, format, registration and fee with FDA before making plans. Verified through search corroboration only — direct fetch of fda.gov was blocked this session; last checked 23 October 2026.
