Pending · due 31 Dec 2026

By the period end, three or more distinct hardware devices with an FDA authorization naming a depressive disorder indication and home use are commercially available in the United States, per FDA device databases and sponsor availability announcements.

Resolved on FDA device authorization records and sponsor announcements only. Count the distinct hardware devices that, at the period end, (a) hold an FDA marketing authorization (510(k) clearance, De Novo grant or PMA approval, per the FDA 510(k), De Novo and PMA databases) whose indications for use name a depressive disorder (major depressive disorder or depression) and home use or use outside a clinical setting, and (b) are commercially available to patients in the United States per the sponsor's public announcement (press release or product website). TRUE if the count is three or more; FALSE otherwise. Devices marketed for depression without such an authorization, software-only products, and devices authorized only for in-clinic use do not count. If the FDA databases and sponsor announcements cannot establish the count 12 months after the deadline, the event is unresolvable.

Resolution source: FDA 510(k), De Novo and PMA databases (authorizations) with sponsor press releases (commercial availability)

Readings: 'On the market' is read as legally marketed in the United States: an FDA authorization naming depression and home use, plus commercial availability. The forecaster counts 'the Flow approval' as the first, so Flow counts if it is marketed by the period end.; 'At-home depression treatment devices' = hardware devices (the forecaster's example is a Flow headset) whose FDA indications for use name a depressive disorder and home use; the device type (tDCS, TMS, nerve stimulation, other) is not restricted; software-only digital therapeutics are not counted.; 'We already have the Flow approval announced, and more is coming' is context for the count, not a separate coded claim.