The FDA cleared the SAINT device on 70 patients from four single-site trials, with effectiveness measured at four weeks
The 2022 clearance letter for the SAINT device rests on 70 patients in four trials, one sham-controlled, and says effectiveness "has not been established beyond the timepoints evaluated".
We have not finished checking this source. No judgement either way. how we score evidence
Caveat on this rating: A 510(k) is a substantial-equivalence determination, and the summary says so. The efficacy figures come from a 29-person trial stopped early at an interim analysis and three open-label studies, all at one site, assessed at four weeks. The record itself flags generalisability and blinding as unevaluated or uncertain.
Significant findings
On 1 September 2022 the FDA cleared the Magnus Neuromodulation System with SAINT Technology (K220177) as a repetitive transcranial magnetic stimulation system, Class II, for "the treatment of Major Depressive Disorder (MDD) in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode". A 510(k) clearance establishes that a device is substantially equivalent to one already on the market, here the Nexstim NBT System 2 (K182700, cleared 22 March 2019); it is not a judgement about how many people respond.
The summary sets out why the protocol is called accelerated. Against the predicate's 600 pulses a session, once a day, 30 sessions over six weeks, 18,000 pulses in total, SAINT delivers 1,800 pulses a session, ten sessions a day, 50 sessions over five days, 90,000 pulses, at 90% rather than 120% of motor threshold.
The regulator wrote its own caveats into the record. The clinical data "were obtained from a total of 70 patients enrolled in four clinical trials (one randomized double-blind, sham-controlled study and three open-label studies) conducted in close geographical proximity. As a result of studies being performed at a single site, generalizability to the broader United States population has not been evaluated." The device "has been evaluated at four weeks post treatment in all four clinical trials. Effectiveness has not been established beyond the timepoints evaluated." In the sham-controlled trial (29 people, 14 active, 15 sham) response was 85.7% versus 26.7% and remission 78.6% versus 13.3%, and the trial "was terminated early based on clear superiority of active treatment vs. sham at the planned interim analysis". Only 19 of 29 completed the blinding check, so "uncertainty remains as to the adequacy of the blinding for the remainder of the study population".
Adverse events in the 14 people on active treatment: headache 57%, fatigue 57%, back or neck pain 50%, pain or discomfort at the treatment site 36%, anxiety or agitation 29%; no serious adverse events. Fatigue was the same in the active and sham groups, which the record attributes to the hours spent in the clinic.
Worth asking
Cleared is not the same as proven for you. The regulator's own record says single site, four weeks, 70 people. What is the clinic's plan for the months after the four-week mark?
Source
510(k) Premarket Notification K220177: Magnus Neuromodulation System (MNS) with SAINT Technology — U.S. Food and Drug Administration, Center for Devices and Radiological Health (2022)
Regulator or national health body
Read the source: https://www.accessdata.fda.gov/cdrh_docs/pdf22/K220177.pdf
How this was scored
- Study design
- Regulatory safety determination
- Funding
- not recorded
- Published in
- Regulator or national health body
- Sample size
- 70
- Preregistered
- not recorded
- Conflicts disclosed
- not recorded
- Independent of proponent
- not recorded
- Retracted
- No
We have not finished checking this source, so there is no scoring to show yet. “We have not checked this yet” and “this is disputed” are different statements, so no scored band is shown rather than a low one.
Read the full scoring rubric, including what it can't tell you.
Published September 15, 2026.
Questions
How strong is the evidence behind this?
veisund rates this source "not yet assessed". We have not finished checking this source. No judgement either way. One caveat travels with that badge: A 510(k) is a substantial-equivalence determination, and the summary says so. The efficacy figures come from a 29-person trial stopped early at an interim analysis and three open-label studies, all at one site, assessed at four weeks. The record itself flags generalisability and blinding as unevaluated or uncertain. The score is calculated from recorded facts about the source — study design, funding, publication venue, sample size, preregistration — not typed in by an editor.
What is the source for this?
510(k) Premarket Notification K220177: Magnus Neuromodulation System (MNS) with SAINT Technology — U.S. Food and Drug Administration, Center for Devices and Radiological Health (2022). Published in: Regulator or national health body. The full source is linked on this page so you can read it yourself.
Who paid for this research, and does that matter?
Study design: Regulatory safety determination. Funding: not recorded. Independence from the proponent is not recorded. Industry sponsorship is one of the most reliably measured biases in medicine, which is why funding carries real weight in the score rather than sitting in a footnote.
Is this medical advice?
This is information to bring to your prescriber, not medical advice and not a reason to change anything on your own. Nothing here is an instruction to stop or reduce a medication. If you are in crisis, call or text 988.
This is information to bring to your prescriber, not medical advice and not a reason to change anything on your own. Nothing here is an instruction to stop or reduce a medication. If you are in crisis, call or text 988.