Known true · enters 23 Mar 2028

The FDA grants a 510(k) clearance, De Novo authorization or PMA approval for a transcranial magnetic stimulation device for a disease or condition beyond those authorized for any TMS device at the statement date.

TRUE on the decision date in the FDA 510(k), De Novo or PMA database of a marketing authorization, dated after 2024-01-04, for a transcranial magnetic stimulation device whose indications-for-use statement names a disease or condition that no TMS device was authorized for on 2024-01-04. Conditions already authorized at the statement date (major depressive disorder including treatment-resistant depression, anxious depression, smoking cessation, obsessive-compulsive disorder, migraine for single-pulse TMS) do not count. A new population or protocol within an authorized condition, a breakthrough designation, an investigational device exemption or a non-US authorization does not count. Resolution source: the FDA 510(k) Premarket Notification database, with the De Novo and PMA databases for other pathways. FALSE at the deadline when no such authorization appears there.

Resolution source: FDA 510(k) Premarket Notification database; De Novo and PMA databases for other pathways

Readings: 'indications' = FDA-authorized indications for use of TMS devices. The forecaster lists the four conditions he treats as current; they are the FDA-cleared psychiatric and addiction indications at the statement date.; 'more indications' = at least one disease or condition new to TMS as a device class; one authorization for one new condition suffices. Any TMS manufacturer counts, since the forecaster names none.; A population expansion or a protocol change within an already authorized condition is not a new indication; a listed condition under another name (MDD for TRD) is not new.; TRD counts as MDD.; The forecaster counts anxious depression as its own indication, so a new patient population for a listed disorder counts as a new indication.

escalated (criterion): Verified K260402 (Wave Neuroscience MeRT, new product code SIG, 21 CFR 882.5802, decision 2026-06-03, PTSD) in the FDA 510(k) database and openFDA. openFDA lists 24 OBP (MDD) and 2 QCI (OCD) clearances from 2024-01-05 to 2026-09-13, no new QMD or OKP entries, and SIG as the only new TMS product code. Population and protocol clearances (NeuroStar adolescents K231926 2024-03-22; Magstim K243869; MagVenture K251119; BrainsWay K251391; Nexstim K252358) are excluded by the criterion text. Magstim's 2025-07-09 'pain' clearance is peripheral nerve stimulation held since K992911 (2000), not a new TMS condition. So under the criterion as written 2026-06-03 is right. But reading 5 says 'a new patient population for a listed disorder counts as a new indication', which makes K231926 (2024-03-22) the first-true date, 26 months earlier and possibly inside deadlines the criterion text resolves FALSE. Criterion and readings contradict each other; a human must pick which governs.