Pending · due 23 Mar 2028
Rules 1.1.0 · as of 14 Sep 2026
Owen Scott Muir · Said 23 Mar 2026 · owen-2470
Quote
“So every psychiatrist should use TMS as one of the treatments they offer if they're treating patients with depression pretty soon that's gonna include psychosis and other conditions of actually just about to submit a publication on auditory hallucinations, large fail phase three data. But I think there's a core tool of psychiatry. So it's not if it's when get on board.”
Psychiatry Boot Camp. Muir predicts TMS will soon extend to psychosis (he is submitting a publication on auditory hallucinations from phase 3 data) and become a core tool every psychiatrist uses.
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 psychosis
- 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 23 Mar 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 · “that's gonna include psychosis ... it's not if it's when”
- 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-0128 · deadline none · bin A
Registry entry
The FDA authorizes a transcranial magnetic stimulation device for a psychotic disorder indication, including auditory hallucinations.
TRUE on the decision date, in the FDA 510(k), De Novo or PMA database, of a marketing authorization dated after 2026-03-23 for a transcranial magnetic stimulation device whose indications-for-use statement names a psychotic disorder or a symptom of psychosis (for example schizophrenia, schizoaffective disorder, auditory hallucinations or auditory verbal hallucinations). A breakthrough device designation, a published trial, a professional-society guideline and off-label clinical use are not an authorization. Resolution source: the FDA device databases (510(k), De Novo, PMA). FALSE at the deadline when no such authorization is listed.
Resolution source: FDA 510(k), De Novo and PMA databases
Readings: 'that's gonna include psychosis' reads as a TMS device authorized for a psychotic disorder indication; auditory hallucinations count as a psychotic symptom.; 'and other conditions' names no countable set, so only the psychosis indication is coded.
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 ›
- 23 Mar 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 14 Sep 2026
- Resolver note
- No FDA marketing authorization for a TMS device with a psychotic-disorder indication is listed as of 2026-09-14. The four TMS 510(k) clearances dated after 2026-03-23 (K260189 and K260560 on 2026-05-22, K261228 on 2026-08-14, K260691 on 2026-08-23) all sit under product code OBP, the transcranial magnetic stimulator code for major depressive disorder; K260691 adds code QCI, obsessive-compulsive disorder. The De Novo database lists only two transcranial grants, from 2013 (migraine) and 2018 (OCD). No PMA for a TMS psychosis indication appears in the same window. Caveat: the openFDA 510(k) extract is current through 2026-08-31, so clearances in the first two weeks of September 2026 may not yet be listed.
- Evidence
- openFDA 510(k) query, transcranial magnetic stimulator product code OBP, decisions after 2026-03-23 (4 records; data last updated 2026-08-31) · 31 Aug 2026
- 510(k) K260691, BTL-699, BTL Industries, decision 2026-08-23, product codes OBP and QCI (depression and obsessive-compulsive disorder) · 23 Aug 2026
- FDA De Novo database, device name transcranial: 2 grants, DEN170078 (2018) and DEN130022 (2013) · 14 Sep 2026
How to read
Registry
Timeline
1 claim against 19 events in the field.
Regulatory decisions