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Neuronetics Q3 revenue rises to $42.0M as accelerated TMS 510(k) awaits FDA review

🇺🇸 Neuronetics, Inc. (STIM) · Wed 04 Nov 2026

Neuronetics narrowed its third-quarter net loss to $1.6M, holding full-year revenue guidance while an FDA 510(k) for an accelerated NeuroStar protocol is under review.

Neuronetics reported third-quarter 2026 results on 4 November, with revenue of $42.0 million, a net loss narrowed to $1.6 million and adjusted EBITDA of $1.9 million. The company's headline described revenue growth of 12.5% and pointed to continued growth at Greenbrook.

On the regulatory front, the company said it filed a 510(k) premarket notification with the US Food and Drug Administration in August for an accelerated transcranial magnetic stimulation (TMS) protocol for its NeuroStar system. The submission is currently under FDA review. No clearance timing was given in the material available.

Neuronetics also signed a distribution agreement with Wave Neuro and plans to seek FDA clearance for a post-traumatic stress disorder (PTSD) indication. Details of the commercial terms and of the planned submission were not provided in the information available.

For the full year, the company kept its revenue guidance at $160 million to $164 million. It tightened its outlook for operating expenses and cash flow, though the specific revised ranges were not available for this report.

By way of context, a 510(k) is the route by which US device makers show that a product is substantially equivalent to a legally marketed predicate device, and it is the usual pathway for Class II devices.

What it means for your team

  • Regulatory teams tracking neuromodulation should watch for the FDA decision on the accelerated NeuroStar protocol, which is the key near-term milestone disclosed.
  • A planned PTSD clearance request signals a possible indication expansion, but no filing has been reported, so timing and evidence requirements remain unknown.
  • Market-access teams should note that any accelerated protocol would affect treatment-session scheduling, though payer implications have not been addressed in the available information.
  • The Wave Neuro distribution deal suggests partner-led commercial expansion; quality and compliance teams may want to follow how distributor responsibilities are structured.

Company's press release (SEC filing): Neuronetics, Inc. ↗

Article written by VigiEye from the official source (Neuronetics, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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