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Advanced Therapies · Brain · rTMS

ALTMS / BLOSSOM TMS

FDA-cleared rTMS for depression. Drug-free, in-office, billed as a course of care when coverage criteria are met.

An FDA 510(k) cleared repetitive transcranial magnetic stimulation (rTMS) system for Major Depressive Disorder. A non-invasive, non-systemic option for patients who have not responded to medication, delivered in-office as a course of care.

New treatment line FDA 510(k) K220625 Class II Billed under the standard codes for the services performed when coverage criteria are met MDD only (US)
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K220625
FDA 510(k) cleared
Class II
21 CFR 882.5805
MDD only
US cleared indication
Billable
When coverage criteria are met
REMED Co., Ltd.
Manufacturer
What it does

FDA-cleared rTMS for depression, delivered as a course.

ALTMS / BLOSSOM TMS is a repetitive transcranial magnetic stimulation system from REMED Co., Ltd., cleared in the United States for adults with Major Depressive Disorder who have not improved on prior antidepressant medication in the current episode. It is a therapy, not a diagnostic, and the treating clinician owns every decision in the course.

The treatment

Repetitive transcranial magnetic stimulation delivered by a figure-8, oil-cooled coil to the left dorsolateral prefrontal cortex, at a target the clinician locates. Drug-free and non-systemic, given in office while the patient sits awake.

The course

10 Hz sessions, five a week for about six weeks per the manufacturer's instructions for use. Sessions run about 19 to 38 minutes per the manufacturer's instructions for use.

The indication

Cleared in the United States for one thing, verbatim: "indicated for the treatment of Major Depressive Disorder in adult patients, who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode."

Known risks. rTMS carries a known risk of seizure. The treating clinician screens every patient against the manufacturer's contraindications, which include implanted devices in or near the head, epilepsy or a history of seizures, and pregnancy (REMED instructions for use, section 1.4).

FDA 510(k) K220625 (REMED Co., Ltd.). The clearance, the verbatim indication and coverage are under Clearance & coverage below.

Who benefits

Who adds rTMS, and how they use it.

One cleared indication, one protocol, run differently by specialty. Every use below sits inside Major Depressive Disorder in adults, and TITN handles placement, staff training, and the operational ramp so your team stays in its own specialty.

Psychiatry

The on-label core: adults with Major Depressive Disorder who have not improved on prior antidepressant medication in the current episode, treated in your own chairs across the course.

Book a call →

Behavioral + Mental Health

A drug-free option to offer inside an existing MDD caseload, delivered by trained staff under the treating clinician's supervision on a fixed protocol.

Talk to TITN →

Interventional Psychiatry

rTMS runs alongside the other procedural work in the practice: an initial mapping and motor-threshold session, then sessions five days a week that schedule like any recurring appointment.

Ask about the room →

Neurology

Referrals from neurology: adults with diagnosed Major Depressive Disorder who have not improved on prior antidepressant medication in the current episode. ALTMS treats the MDD only.

Neurology page →

Integrative + Functional

A non-systemic addition to the care plan for patients with diagnosed MDD who want to avoid another prescription, tracked with standardized depression scales across the course.

Integrative page →

Concierge + Longevity

For the patient with diagnosed MDD who wants an in-office treatment scheduled around the rest of their week.

Geriatrics page →

Pain Management

Pain practices that also manage diagnosed Major Depressive Disorder in adults. ALTMS treats the depression, not the pain.

Pain Management page →
How the Therapy Works

How does an rTMS course actually work, session by session?

rTMS is a protocol, not a one-off. The first session establishes the patient-specific settings; the rest of the course delivers consistent stimulation over several weeks.

01

Cortical mapping

The clinician locates the treatment target over the prefrontal cortex, the cortical region associated with mood regulation. Done once at the start of the course.

02

Motor threshold

The system determines the patient's individual motor threshold, the dose reference that calibrates stimulation intensity to that patient. Captured on the initial treatment line.

03

Daily delivery

Repetitive magnetic pulses are delivered in each session while the patient sits awake and alert. Sessions repeat across the multi-week course, each one its own treatment line.

04

Track and adjust

Response is tracked with depression rating scales. If re-mapping is needed, the motor threshold is re-determined and coded as its own line. The clinician owns every decision.

In the Room

Five finishes, built to disappear into a calm office.

ALTMS / BLOSSOM TMS ships in five cosmetic finishes so the device reads as furniture, not equipment. Sand is the finish shown. Final product photography is added per finish.

Swatch chips show finish direction; product photography per finish follows. Sand is the finish shown in the hero.

Pairs With · PharmacoCheck+

Why run pharmacogenomic testing alongside an rTMS course?

rTMS is often considered after one or more antidepressants underperformed. PharmacoCheck+ pharmacogenomics tests how the patient metabolizes psychiatric medications, adding measured context to that history and to the care plan around the rTMS course.

For the clinician · PharmacoCheck+

Psychiatric medication metabolism, made explicit.

A pharmacogenomic panel that reports how the patient is likely to metabolize common psychiatric medications. It does not prescribe; it informs the conversation about why prior antidepressant trials may have fallen short and what that means for the path forward.

  • Provider-ordered, patient-specific metabolism report
  • Context for the "failed prior medication" history that rTMS coverage often requires
  • One coordinated workflow with the ALTMS course, run through TITN
Ask about PharmacoCheck+ →
For the practice · BMTG support

Operational and clinical support around the line.

BMTG, TITN's sister service, supports the documentation and clinical-context layer around advanced therapies. As ALTMS grows into a standard TITN treatment line, BMTG helps keep the paperwork, scales, and reporting consistent across sessions.

  • Standardized depression-scale tracking templates
  • WAVi brain baseline and retest, where the clinician wants quantified documentation
  • Coordination so your team stays in its specialty
BMTG overview →
Clearance & Coverage

What is ALTMS FDA cleared to treat in the United States?

ALTMS / BLOSSOM TMS is FDA 510(k) cleared for Major Depressive Disorder. The international instructions for use list other indications. Those are not cleared in the United States, so TITN does not market them. The discipline is the point.

FDA 510(k) Clearance
REMED Co., Ltd. · Class II medical device
510(k) cleared
FDA 510(k) record
K220625 · ALTMS Magnetic Stimulation Therapy System / Blossom TMS Therapy System, REMED Co., Ltd. Cleared substantially equivalent on April 6, 2022. Product code OBP, regulation 21 CFR 882.5805, neurology panel. The FDA defines product code OBP as a transcranial magnetic stimulator for the treatment of major depressive disorder.
Search the FDA 510(k) database (K220625) →
US cleared indication
"Indicated for the treatment of Major Depressive Disorder in adult patients, who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode."
Verbatim from the manufacturer's US instructions for use (REMED, section 1.3) for the cleared MDD indication under product code OBP.
How rTMS works
  • Repetitive TMS · a focused magnetic field induces small electrical currents in targeted cortical tissue
  • Non-invasive · no surgery, no anesthesia, no sedation
  • Non-systemic · no drug circulating through the body, so the side-effect profile differs from medication
Coverage
A course of care, decided by your payer
Coverage Decided by your payer Billed under the standard codes for the services performed when coverage criteria are met. Coverage and payment are decided by each payer on the documented indication. A standard course runs five sessions a week for about six weeks per the manufacturer's instructions for use.
What a course of care covers
  • Initial treatment, including cortical mapping, motor threshold determination, delivery, and management (once per course)
  • Subsequent delivery and management, per session (the bulk of the course)
  • Subsequent motor threshold re-determination with delivery and management, when re-mapping is required

Coverage typically requires documented MDD with failure of one or more adequate antidepressant trials in the current episode. Verify your locality with the CMS PFS Look-Up. Coverage and reimbursement vary by payer.

What TITN claims: ALTMS / BLOSSOM TMS is FDA-cleared rTMS for Major Depressive Disorder, delivered in-office as a non-invasive course of care, billed under the standard codes for the services performed when coverage criteria are met. Coverage and payment are decided by each payer on the documented indication.
What TITN does not claim: The US clearance is for Major Depressive Disorder only. TITN does not market ALTMS / BLOSSOM TMS for epilepsy, OCD, Parkinson's disease, tinnitus, multiple sclerosis, panic disorder, or hallucinations, even though some of these appear in the manufacturer's international (Korean) instructions for use. Those indications are not FDA-cleared in the United States. ALTMS is a therapy, not a diagnostic; it does not diagnose any condition.
Common questions

ALTMS, answered.

The questions practices ask before they add an rTMS treatment line.

What is ALTMS cleared to treat?

ALTMS, also sold as BLOSSOM TMS, is FDA 510(k) cleared, not FDA approved, under K220625 (REMED Co., Ltd., product code OBP, 21 CFR 882.5805, April 6, 2022). The United States clearance covers one indication: treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.

How does rTMS work for depression?

Repetitive magnetic pulses are delivered by a figure-8, oil-cooled coil to the left dorsolateral prefrontal cortex, at a target the treating clinician locates. The focused magnetic field induces small electrical currents in that cortical tissue. It is non-invasive and non-systemic: no surgery, no anesthesia, no sedation, and no drug circulating through the body, so the side-effect profile differs from medication.

How long is a course of treatment?

Per the manufacturer's instructions for use, a standard course runs 10 Hz sessions five days a week for about six weeks, with sessions of roughly 19 to 38 minutes. The first session establishes cortical mapping and the patient's motor threshold; the rest deliver the protocol. The treating clinician sets the actual course and owns every decision within it.

What are the contraindications for TMS?

The treating clinician screens every patient against the manufacturer's contraindications, which per the REMED instructions for use (section 1.4) include implanted devices in or near the head, epilepsy or a history of seizures, and pregnancy. Conductive or ferromagnetic metal near the treatment coil, such as cochlear implants, deep brain stimulators, or aneurysm clips, is the central concern in that screen.

What are the side effects of rTMS?

Commonly reported effects are scalp discomfort at the treatment site and headache during the first sessions, typically mild and decreasing as the course continues. Seizure is a rare but recognized risk of rTMS, and it is the reason the seizure-history screening question exists. The treating clinician reviews the full risk profile with each patient before the course begins.

Does it require anesthesia or downtime?

No. rTMS is non-invasive and delivered while the patient sits awake and alert, with no anesthesia, no sedation, and no recovery downtime. Patients drive themselves home and return to the day. That is one of the practical differences from electroconvulsive therapy, which requires anesthesia and induces a generalized seizure in a monitored setting.

How is TMS different from ECT?

They are separate procedures and are not interchangeable. rTMS is non-invasive, requires no anesthesia, does not induce a generalized seizure, and is delivered in an outpatient chair across a multi-week course. ECT is a more invasive procedure performed under anesthesia and is typically reserved for more severe or treatment-refractory presentations. The treating clinician decides which, if either, fits the patient.

What staffing and supervision does an rTMS line require?

A treating physician determines candidacy, performs or directs cortical mapping and motor-threshold determination, and oversees the course. Daily sessions are then delivered by trained staff under that physician's supervision on a fixed protocol. TITN handles placement, staff training, and the operational ramp so the practice stays in its own specialty rather than building the workflow from scratch.

How is it coded, and is it covered?

A course of care typically maps to one code for initial treatment including cortical mapping and motor-threshold determination, one for subsequent sessions, and one for re-mapping when it is required. Coverage and payment are decided by each payer on the documented indication, and most require documented Major Depressive Disorder with prior antidepressant failure in the current episode.

How does ALTMS fit alongside TITN diagnostics?

When clinical assessment, informed by a measured brain baseline, leads toward depression care, ALTMS is the treatment line, and a follow-up WAVi assessment adds a measured data point to the clinical record. PharmacoCheck+ pharmacogenomics adds context on how the patient metabolizes psychiatric medications, which informs the medication conversation running alongside the rTMS course.

See It + Pair It

Watch a session, then build the full pathway.

90-second rTMS walkthrough In production. Book a call for a live demo in the meantime.
WAVi Scan System Pairs with · Brain

WAVi Scan System

Capture a measured brain baseline before the course, then retest to document change.

 PharmacoCheck+ Pharmacogenomics Pairs with · Molecular

PharmacoCheck+ Pharmacogenomics

How the patient metabolizes psychiatric medications. Context for the next care decision.

 rTMS clinical evidence Read · Evidence

rTMS clinical context

The peer-reviewed and regulatory basis for rTMS in Major Depressive Disorder.

Want to see ALTMS in your office?

Book a 15-minute call. We will walk through the course, the room and staffing it needs, and coverage for your payers, then arrange a demonstration.

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Write to support@transitionitnow.com and Roberto or Weston answers personally.
(213) 444-6123 · Santa Monica, CA
Sources & verification Every clearance, code, and figure on this page traces to a live source. View the sources

Verified live August 27, 2026. Spot a broken or outdated link? Email support@transitionitnow.com.

FDA & regulatory

  1. FDA 510(k) database · search K220625, ALTMS Magnetic Stimulation Therapy System / Blossom TMS Therapy System, REMED Co., Ltd., Class II, product code OBP, 21 CFR 882.5805, decision substantially equivalent April 6, 2022, neurology panel
  2. FDA device classification, product code OBP · transcranial magnetic stimulator for the treatment of major depressive disorder (the US cleared indication scope)
  3. US clearance is restricted to Major Depressive Disorder. Other indications in the manufacturer's international (Korean) IFU are not FDA-cleared and are not marketed by TITN.

CPT & reimbursement

  1. CPT (AMA) · therapeutic repetitive transcranial magnetic stimulation treatment: initial, including cortical mapping and motor threshold determination; subsequent delivery and management per session; subsequent motor threshold re-determination with delivery and management. The initial code is reported once per episode and not with the others.
  2. CMS Physician Fee Schedule Look-Up · confirm current locality rates with your own certified coder
  3. CMS Medicare Coverage Database · see the local billing-and-coding articles for TMS in adults with Major Depressive Disorder for documentation and coverage requirements
  4. Coverage and payment are decided by each payer on the documented indication. Coverage typically requires documented MDD with prior antidepressant failure in the current episode.

Manufacturer documentation

  1. REMED Co., Ltd. · manufacturer of the ALTMS / BLOSSOM TMS Therapy System (510(k) holder of record, K220625).
  2. Cosmetic finishes (Black, Gray, Sand, Taupe, White) per the manufacturer's product renders on file.

Paired services

  1. WAVi Scan System · FDA 510(k) cleared EEG / ERP, see manufacturer research at wavimed.com/research for quantified brain documentation around a course.
  2. PharmacoCheck+ pharmacogenomics · provider-ordered psychiatric medication-metabolism panel, paired with the ALTMS course through TITN.