On September 16, 2025, BrainsWay announced FDA clearance for an accelerated Deep TMS protocol that cuts treatment time by 75%—a breakthrough poised to reshape interventional psychiatry. The newly cleared accelerated protocol for Deep TMS treatment compresses what was previously a four-week schedule into just six days of intensive sessions with comparable response and remission rates.
See the official BrainsWay announcement here.
This advancement means patients with Major Depressive Disorder (MDD), including those with comorbid anxiety, can potentially achieve faster relief, reduced clinic visits, and fewer barriers to starting treatment.
For clinic leaders, this isn’t just a clinical advance—it’s a powerful new lever for growth, differentiation, and patient conversion.
Why This Matters for Mental Health Clinics Right Now (Accelerated TMS insights)
Most TMS providers focus heavily on increasing lead volume through ads, outreach, or partnerships. But this new protocol allows clinics to leverage speed itself as a differentiator, without increasing ad spend.
From Rise4’s perspective—as a BrainsWay preferred marketing partner and an agency that’s helped build and scale 100+ TMS programs across the U.S.—this change impacts three key levers of clinic growth:
In an environment where patients are often in crisis, time matters. The accelerated Deep TMS protocol delivers:
- 5 sessions/day for 6 days during the acute phase
- 87.8% response rate in accelerated group vs. 87.5% in standard protocol
- Median remission in 21 days (vs. 28 days standard) with comparable overall efficacy, even though remission percentages vary slightly between groups
- Sessions lasting approximately 10 minutes
Clinics can now market:
- 6-day breakthrough treatments instead of ‘month-long commitments’
- Relief measured in days, not weeks
- A treatment path that resonates emotionally with patients in crisis
2. Conversion Rates Will Rise with Accelerated TMS
Quicker timelines don’t just help patients—they help your front office convert more leads.
- Fewer drop-offs between consult and treatment
- Less hesitation from patients with scheduling or financial barriers
- Streamlined messaging for coordinators and intake teams
At Rise4, we’ve already seen clinics dramatically improve treatment uptake by integrating “accelerated TMS” messaging into their lead generation, nurture, and scheduling processes.
3. TMS Insurance Coverage Gaps: Challenges and Solutions
Important note: FDA clearance does not mean insurance coverage. Current coverage limits Deep TMS to two treatments per day. This means clinics must:
- Develop flexible financing options (payment plans, HSAs, etc.)
- Communicate accelerated protocols as a premium recovery option
- Consider a phased rollout of accelerated messaging based on payer mix
At Rise4, we help clinics bridge the gap, creating demand among patients who want faster solutions, while building internal systems that move those leads to treatment despite coverage limitations.
“This isn’t just another FDA clearance. It’s the beginning of a new standard in patient experience—faster relief, fewer visits, and broader access. Clinics that adapt early will stand out and grow.”
“Patients don’t want to wait nearly two months to get through a standard TMS course. When they hear that accelerated treatment can bring relief in as little as six days, it resonates, and we’ve already seen it lead to more patients starting care.”
Update Your Messaging:
- Shift from “standard protocol” to “accelerated relief”
- Use terms like “6-day breakthrough,” “FDA-cleared fast-track,” and “rapid depression recovery”
Train Your Team:
- Align your intake staff around scheduling urgency
- Prepare for patient financing conversations
- Ensure clinical understanding of new treatment cadence
Future-Proof Your Growth Engine:
- Integrate accelerated TMS into your CRM workflows
- Launch landing pages or ads tailored to this protocol
- Explore hybrid campaigns for cash-pay or partial-insurance options
The FDA clearance was based on a multi-center, randomized, non-inferiority trial showing:
| Metric | Accelerated Protocol | Standard Protocol |
|---|---|---|
| Depression Score Reduction | -19.02 | -19.79 |
| Response Rate | 87.8% | 87.5% |
| Remission Rate | 78.0% | 87.5% |
| Median Time to Remission | 21 Days | 28 Days |
| Adverse Events | None Severe Reported* | None Severe Reported* |
*Adverse events were generally mild to moderate; headaches were more common in the accelerated group, and one severe migraine occurred in the standard group. Two subjects discontinued due to AEs (anxiety, hypomania). No new safety questions were identified.
In the multicenter, randomized study supporting clearance, adjusted mean HDRS-21 change at 6 weeks was −19.02 (accelerated) vs −19.79 (standard), response at 6 weeks was 87.8% vs 87.5%, and remission was 78.0% vs 87.5%, respectively; the median time to remission was 21 vs 28 days.
Want to integrate accelerated TMS into your clinic’s growth strategy?
What is accelerated Deep TMS?
Does insurance cover accelerated TMS?
How can my clinic start promoting accelerated TMS?
Update landing pages and ad copy to highlight “FDA-cleared 6-day option,” train intake on urgent scheduling, add financing options to your intake script, and track “patients starting treatment” as a KPI in your CRM.
