The Apollo TMS Therapy System is a transcranial magnetic stimulation (TMS) system made by MAG & More GmbH in Munich and distributed in the United States by neurocare. It is FDA-cleared for adults with major depressive disorder (MDD) who have not improved enough on antidepressant medication, and since 2025–2026 also as an adjunct for adult OCD, as an adjunct for adolescent MDD (ages 15–21), and for decreasing anxiety symptoms in adults with MDD. HealthTech USA is an authorized Apollo distributor: we install the system, train your team and service it after the sale.
What the FDA has cleared Apollo for
Apollo is a 510(k) device, so the correct term is FDA-cleared. These are the clearances on record, with the indication wording quoted from each FDA summary.
| 510(k) | Decision date | Cleared indication (FDA wording) |
|---|---|---|
| K180313 | May 4, 2018 | "Treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode." |
| K232639 | May 24, 2024 | Same indication as K180313. This clearance adds the intermittent theta burst (iTBS) protocol. |
| K243539 | August 18, 2025 | Adult MDD as above, "as well as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD)." |
| K243700 | September 4, 2025 | Adult MDD as above, "and as an adjunct for the treatment of MDD in adolescent patients (age 15-21)." |
| K260560 | May 22, 2026 | "Treatment of depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from Major Depressive Disorder (MDD)" who have not improved on medication in the current episode. Covers Apollo and Apollo light. |
Clearance is specific to the device and the indication. Treatment decisions, patient selection and protocols belong to the prescribing clinician; this page is equipment information for practices, not medical advice.
Treatment protocols on Apollo
Apollo supports the two protocols most practices use:
- Standard 10 Hz rTMS. The protocol in the original clearance: 3,000 pulses per session at 120% of motor threshold. A session runs roughly 19 to 37.5 minutes depending on the inter-train interval.
- Intermittent theta burst (iTBS). Added with K232639. An iTBS session delivers 600 pulses in about three minutes, the protocol shown to be non-inferior to 10 Hz rTMS in the THREE-D trial (Blumberger et al., The Lancet, 2018).
Shorter sessions matter for the business side. With iTBS, one chair can see far more patients in a day, which changes your staffing, scheduling and how quickly the system pays for itself.
What HealthTech USA adds when you choose Apollo
Most equipment companies are sales-only. We stay with you after the install:
- Installation and calibration in your clinic, so the system is set up for your rooms and your workflow.
- Hands-on staff training for the clinicians and technicians who will run treatments every day.
- Ongoing service and support for as long as you run the system.
- Workflow and billing guidance. In our experience, workflow, billing and staff training decide whether a practice sees a return on new technology in months, in years or not at all. We help you plan all three before the first patient session.
Questions practices ask before buying Apollo
Is Apollo FDA-approved?
Apollo is FDA-cleared, not "approved". It went through the 510(k) pathway, and the clearances are listed in the table above with links to the FDA records.
Can Apollo be used for OCD?
Yes, as an adjunct treatment for adults with OCD under clearance K243539 (August 2025).
Can Apollo be used with adolescents?
Yes, as an adjunct for MDD in adolescents aged 15 to 21 under clearance K243700 (September 2025).
How long is an Apollo session?
About 19 to 37.5 minutes for standard 10 Hz rTMS, and about three minutes for iTBS.
How much does an Apollo TMS machine cost?
Pricing depends on configuration, financing and the support package, so we quote it for your practice. For published price ranges across brands and the costs that come after the purchase, see our guide to TMS machine cost.
Talk to us about Apollo
Contact our team for a quote or a walkthrough of how Apollo would fit your practice. If you already run TMS equipment and need help keeping it running, see TMS machine service and support.
Reviewed by Sean Talamantes, R. EEG T., Director of Services at HealthTech USA. Sean has installed, serviced and trained clinic staff on every assessment and treatment technology HealthTech USA sells. FDA clearance details verified against FDA records on September 28, 2026.