Not admitted · Outcome already public
Rules 1.1.0 · as of 14 Sep 2026
Owen Scott Muir · Said 27 May 2026 · owen-2252
Quote
Outcome already public
“The label—also not yet available on the FDA website—must say this is an adjunctive approval: The device is intended for use alongside – not as a replacement for – a clinician-directed treatment plan.”
Neurovalens Modius Spero vestibular nerve stimulator (VeNS), FDA De Novo grant for PTSD announced the day before. The FDA label was not yet posted; the author infers from company language that the label will state an adjunctive indication alongside a clinician-directed treatment plan.
The outcome had been publicly determined or announced by the deciding body or sponsor on the statement date.