Pending · due 11 May 2028
Rules 1.1.0 · as of 14 Sep 2026
Owen Scott Muir · Said 11 May 2026 · owen-2239
Quote
“We will, of course, need to replicate these findings, and more work will be done before there’s an FDA label from somebody. But it’s coming—obviously.”
After reviewing the third RCT showing TMS works in pediatric ADHD (first with brief iTBS at 80% threshold), the author forecasts that replication and more work are needed but an FDA label for TMS in ADHD from some company is coming. He then says payers need to hear the clamor as they have for accelerated TMS generally.
Intake
- EventA proposition written from a template on the asset, with a resolution criterion and a named public source, before the outcome is looked up. The same event resolves every person's items on it. Method ›
- FDA authorizes a TMS device for ADHD
- AreaOne of five topic classes: regulatory decisions, clinical trial outcomes, company and market outcomes, payer and policy, practice adoption. Every event has one area. Method ›
- Regulatory decisions
- DeadlineThe date by which the event must happen for the item to be true. It comes only from the person's words through the anchor table. Method ›
- None stated · undated panelItems with no deadline in the person's words, scored on a uniform 24-month window from the statement date. Part of the headline panel since rules 1.1.0; also shown on its own. Method ›, 24-month window to 11 May 2028
- Probability
- 0.90 LexiconThe fixed five-bin table that turns a phrase into a probability. The strongest phrase in the claim sentence decides; coders never read tone. Method › · binOne of five lexicon steps: A 'will' 0.90, B 'probably' 0.70, C 'may' 0.50, D 'unlikely' 0.30, E 'never' 0.10. A stated number goes to the nearest bin for calibration only. Method › A · “it’s coming—obviously”
- Base rateThe probability a published external study gives an event of that class and stage, fixed at intake. Halved when the item window is shorter than the class median time to decision. Never learned from the ledger's own items. Method ›
- None in the table
- Tags
- retrospective
- Coder BCohen's kappa: agreement between two coders beyond chance, from -1 to 1. Reported for admit, event, deadline, bin and asserts from the second-coder match test. Method ›
- admittedA statement that passed intake: sincere, the person's own claim, forward-looking, inside the five areas, and not excluded by a reason code. Only admitted statements become items. Method › · event E-0063 · deadline none · bin A
Registry entry
The FDA grants a marketing authorization (510(k) clearance, De Novo grant or PMA approval) for a transcranial magnetic stimulation device whose indications for use include ADHD.
TRUE on the decision date in the FDA 510(k), De Novo or PMA database of a marketing authorization for a transcranial magnetic stimulation device, from any sponsor, whose indications for use name attention-deficit/hyperactivity disorder (adult or pediatric). Any setting of use (clinic or home) counts, as the claim names none. A breakthrough device designation, an investigational device exemption, a trial result or a publication is not an authorization. Off-label use and clinical guidelines do not count. FALSE at the deadline when no such authorization decision is dated in the FDA databases by then. Resolution source: the FDA 510(k), De Novo and PMA databases.
Resolution source: FDA 510(k), De Novo and PMA databases
Readings: 'an FDA label from somebody' = a marketing authorization for any sponsor's TMS device with ADHD in the indications for use; the forecaster names no company.; 'it' in 'it's coming' = the FDA label for TMS in ADHD, per the surrounding sentences on the pediatric ADHD iTBS trials; a pediatric-only or an adult-only ADHD indication both count.
How to read
Coder A
Resolution
- Effective deadlineAn item enters the score only when its deadline has passed and the outcome is true or false. A claim already known true still waits for its deadline. Method ›
- 11 May 2028
- Outcome1 if the registry event happened on or before the item's deadline, 0 if it did not. Written by a resolver who never sees p. Method ›
- not occurred · checked through 13 Sep 2026
- Resolver note
- No 510(k) clearance, De Novo grant or PMA approval of a transcranial magnetic stimulation device with ADHD in its indications for use is dated by 2026-09-13. FDA product-code classifications for ADHD devices are limited to QGL (transcutaneous trigeminal nerve stimulator, the Monarch eTNS, De Novo 2019) and QFT (digital therapeutic software); the seven TMS product codes (OBP, SIG, QFF, SGE, QCI, OKP, QMD) cover MDD, PTSD, OCD, migraine and smoking cessation, not ADHD. None of the 89 TMS 510(k) records (latest K260691, decided 2026-08-23) or the three TMS-related De Novo grants names ADHD, and openFDA lists no TMS PMA. Trials, publications and off-label use do not count.
- Evidence
- openFDA device classification: product codes whose definition mentions 'attention deficit' (QGL transcutaneous nerve stimulator for ADHD; QFT digital therapeutic software for ADHD)
- openFDA device classification: transcranial magnetic stimulation product codes (OBP, SIG, QFF, SGE, QCI, OKP, QMD), none for ADHD
- openFDA 510(k) database: transcranial magnetic stimulation clearances sorted by decision date (89 records; latest K260691, 2026-08-23), none naming ADHD
- FDA De Novo database search, device name 'magnetic': 3 results (DEN170078, DEN150007, DEN130022), none for ADHD · 7 Sep 2026
- FDA permits marketing of first medical device for treatment of ADHD (Monarch eTNS, trigeminal nerve stimulation, not TMS) · 19 Apr 2019
How to read
Registry
Timeline
1 claim against 11 events in the field.
Regulatory decisions