More than Meds: Every FDA Non-Medication Treatment in Psychiatry (2026 Guide)
By Patricia Pop, MD - patriciapopmd.com
Last updated: February 2026
A colleague recently asked our psychiatry group about Rejoyn, an FDA-authorized app for major depression. Then, a patient asked me about Flow, an at home brain stimulation device.
It's one of a growing family of non-medication treatments that are apps, devices, and neurostimulation systems. They've gone through the FDA's regulatory process.
This post is my attempt to compile them all in one place for you (and for me!), explain what "FDA approved" actually means (and doesn't mean), and give you the resources to stay current.
Buckle up! (or zoom in to where your interests are).
It’s a tome.
First: What Does "FDA Approved" Actually Mean? (Spoiler: It Depends)
Almost everyone (patients, media, even some companies marketing their products) says "FDA approved." But technically, "FDA approved" refers to only one specific regulatory pathway (the most rigorous one). The other pathways are "FDA cleared" and "FDA granted." You'll also hear the unofficial umbrella term "FDA authorized," which covers all of the above. The differences matter clinically and for what you can tell patients about the evidence behind a treatment.
The Three Main Pathways for Devices
Skip if you’re easily bored (but it’s good stuff if you want to dive in later)
1. FDA Approved (PMA or Premarket Approval)
This is the most rigorous pathway, reserved for Class III (highest-risk) devices. Think heart pacemakers, cochlear ear implants, or deep brain stimulation systems (those are installed by a surgeon). The manufacturer must demonstrate safety and effectiveness from scratch, typically through extensive clinical trials. This is the gold standard.
This requires the most comprehensive clinical evidence which includes typically multiple studies, large RCTs, extensive safety and long-term follow-up data. The manufacturer must demonstrate safety and effectiveness from scratch, with the highest standards of evidence.
2. FDA Cleared (510k Premarket Notification) This is the pathway for Class I and II low-to-moderate risk devices. The manufacturer demonstrates that their device is "substantially equivalent" to an existing device (called the "predicate”) that is legally marketed). This does not require the same level of original clinical trial evidence.
Most of the digital therapeutics for psychiatry have come through this route! Many 510k FDA Cleared devices rely on being substantially similar to an already-existing device and may not even have their own randomized controlled trial data.
We’re using substantially similar to" instead of "just as good as.” This is because the FDA isn't actually evaluating whether it works as well. They're evaluating whether it's similar enough in design and intended use that it doesn't raise new questions about safety or effectiveness. It's more of a "close enough that we don't need to re-examine it from scratch" standard, which is a subtly different (and arguably lower) bar than "just as good” (in effectiveness).
And here's a wrinkle that surprised me: a 2025 analysis in Mental Health Research led by Herpertz found that several digital therapeutics ran their clinical trials on an earlier prototype or a different software platform than the version patients actually end up downloading. The trial tested one thing; the product you're prescribing is technically something else (hopefully better but, you never know).
3. FDA Granted (De Novo Classification) This pathway is for new devices that are low-to-moderate risk but where no similar device has already been reviewed by the FDA. Even if similar products exist on the market somewhere, they don't count unless they've been through an FDA pathway themselves.
Because there's no existing reference point, the FDA essentially creates a new product category, sets the rules for it, and that first product becomes the benchmark for future devices that want to come through the easier route of “FDA cleared”. Think of it as: someone has to be first through the door, and De Novo is how they build the door.
This was the pathway for the very first digital therapeutics in psychiatry, such as reSET (for substance use disorders) in 2017 and EndeavorRx (for ADHD) in 2020. Most of the apps that followed got cleared through 510k FDA Clearance by pointing back to those trailblazers.
Because there's no product to compare to (that’s been through the FDA process), the FDA needs to evaluate the device on its own merits. This typically does require clinical evidence (often at least one RCT) because the FDA has to establish that this entirely new type of device is safe and effective enough to exist as a Class I or II product. But it's still less than “FDA approved” requirements, because the device is low-to-moderate risk by definition.
4. And One More: The Humanitarian Device Exemption (HDE)
For conditions affecting fewer than 8,000 patients per year in the United States, the FDA offers the HDE pathway. This requires demonstration of safety but not effectiveness. It only asks that the probable benefit outweighs the risk. Deep brain stimulation for treatment-resistant OCD came through this pathway in 2009.
The Financial Reality
Getting any treatment through FDA regulatory pathways is expensive. A 2022 study published in JAMA Network Open estimated the mean out-of-pocket development cost for a novel therapeutic complex medical device at approximately $54 million. Factor in the cost of failed products and cost of capital, the fully capitalized cost - you’re looking at around $522 million.
That’s a lot.
For simpler devices going through 510k FDA Clearance, costs are lower but still substantial. Usually, it’s in the hundreds of thousands to low millions including testing, consulting, and FDA user fees. For drugs, the FDA application fee alone for an application with clinical data was over $4.3 million as of 2025.
This creates an inherent selection bias: treatments that make it through the FDA process tend to be ones backed by companies that see a profitable path forward. Effective treatments that can't be easily patented or monetized (think: specific exercise protocols, dietary approaches, certain psychotherapeutic techniques) may never go through this process - not because they don't work, but because nobody can reliably get their investment back.
This is worth being transparent about with patients. Looking towards FDA status is important. It often gives you some level of clinical reliability, legal soundness, and importantly, often predicts insurance coverage. However, FDA authorization tells you something went through regulatory review; the absence of FDA authorization doesn't tell you a treatment is ineffective. Some are, some aren’t.
The Complete List: FDA Non-Medication Treatments by Psychiatric Diagnosis
Here is every currently FDA-approved, -cleared, or -granted non-medication treatment that I could identify for psychiatric conditions, organized by diagnosis.
Of course - we are more than our diagnoses <3
But let’s use that model here for organization…
Note that "currently available" is a moving target. Some products have received FDA marketing authorization but are no longer commercially available. I've tried to note market status where it could be found.
Major Depressive Disorder (MDD)
Digital Therapeutics / Apps:
Rejoyn (Otsuka Precision Health): 510(k) cleared, April 2024.
Prescription app-based digital therapeutic for adults 22+ with MDD, as an adjunct to antidepressant medication.
Combines Emotional Faces Memory Task (EFMT) exercises with brief CBT-based lessons and text messaging.
Six-week treatment program, ~2 hours/week.
Cost: $220 for 6 weeks; $99 with coupon code REJOYN55 for those without insurance coverage (offer through June 2026).
The pivotal MIRAI trial (n=386) showed improvement in depression symptoms vs. control, though some experts have noted the effect size was modest. No side effects observed in the trial.
Neurostimulation Devices:
Repetitive Transcranial Magnetic Stimulation (rTMS): Multiple systems FDA cleared since 2008.
First cleared was the NeuroStar TMS Therapy system for adults with MDD who have failed at least one adequate antidepressant trial. Subsequent clearances include BrainsWay's Deep TMS (H-coil, reaches deeper brain regions), MagVenture, neurocare Apollo, and others.
Response rates of roughly 50%, with about 30% achieving remission.
Non-invasive, no anesthesia required. Able to drive to/from appointments.
In 2024-2025, multiple TMS systems also received clearance for adolescents aged 15-21 with MDD, a significant expansion.
Intermittent Theta-Burst Stimulation (iTBS): FDA cleared 2018.
A faster TMS protocol using rapid bursts in sessions lasting about 3 minutes (vs ~20-40 minutes for standard rTMS).
The Stanford Neuromodulation Therapy (SNT/SAINT) protocol combines iTBS with fMRI-guided targeting and accelerated delivery over 5 days, with strikingly high remission rates in trials.
BrainsWay Deep TMS: FDA cleared for MDD and OCD.
Uses an H-coil to stimulate deeper and broader brain regions compared to standard figure-8 coils. Also received clearance for an accelerated adult protocol.
Electroconvulsive Therapy (ECT)
ECT devices are FDA regulated (Class III, but through a unique regulatory history).
ECT remains one of the most effective treatments for severe, treatment-resistant depression, particularly with acute suicidality or catatonia.
Response rates often exceed 50-70%. Requires general anesthesia.
Cognitive side effects (particularly memory) are a real consideration that should be discussed with your clinician, but often outweighs the suffering at this level of depression for many people.
Vagus Nerve Stimulation (VNS): FDA Approved in 2005 for chronic or recurrent depression (unipolar or bipolar) in adults 18+ who have failed at least four adequate antidepressant interventions.
Surgically implanted device in the upper chest stimulates the left vagus nerve. Improvements may take months; long-term studies show over 65% improvement over 5 years, with ~40% remission. Insurance coverage has historically been very challenging to obtain.
Flow Neuroscience tDCS (transcranial Direct Current Stimulation): FDA Approved, December 2025.
This is a major milestone: the first FDA-approved home-use non-invasive brain stimulation device specifically for depression treatment.
Indicated for moderate-to-severe MDD in adults 18+ as monotherapy or adjunctive treatment, in patients who are not considered treatment-refractory to medication.
This is notable because it positions tDCS as an early-line intervention. The device is a wearable headset for at-home use.
Generalized Anxiety Disorder (GAD)
Digital Therapeutics / Apps:
DaylightRx (Big Health): FDA Cleared, August 2024. The first FDA-cleared digital treatment specifically for GAD.
Prescription app for adults 22+. Provides a 90-day CBT-based treatment with interactive lessons on cognitive restructuring, applied relaxation, and stimulus control.
Panic Disorder
Biofeedback/Neurostimulation:
Freespira: FDA cleared, 2018; additional clearance for adolescents 13-17 in 2025.
Prescription biofeedback device for panic disorder and PTSD. Uses a nasal sensor to measure respiration rate and exhaled CO₂ combined with guided respiratory training and 1:1 video coaching.
At-home treatment, two 17-minute sessions daily for 28 days. Clinical data show 54% mean reduction in panic disorder symptom severity in adolescents, with 68% achieving clinically meaningful improvement.
Post-Traumatic Stress Disorder (PTSD)
Freespira: FDA cleared for PTSD symptoms.
Adolescent data show 44% mean symptom reduction on the PCL-5, with 75% no longer meeting the diagnostic threshold after treatment.
NightWare: De Novo granted, November 2020.
Prescription digital therapeutic for adults 22+ with nightmare disorder or PTSD-related sleep disturbance. Uses an Apple Watch-based system that analyzes heart rate and body movement during sleep and delivers gentle vibration to interrupt nightmares without fully waking the sleeper. Pivotal trial results were modest. The treatment group showed a favorable trend for improving perceived sleep, but individual measures didn't reach statistical significance. Currently available primarily through the Department of Defense and VA. They have not secured broad commercial insurance coverage.
Obsessive-Compulsive Disorder (OCD)
Neurostimulation:
BrainsWay Deep TMS: FDA cleared for OCD.
Uses H-coil technology targeting deeper brain structures. This made BrainsWay's system the first FDA-cleared non-medication treatment specifically for OCD via TMS).
Deep Brain Stimulation (DBS) via Medtronic: Humanitarian Device Exemption granted, 2009.
For severe, treatment-resistant OCD in adults who have failed at least three SSRIs and adequate CBT.
Surgically implanted electrodes in the anterior limb of the internal capsule.
Roughly two-thirds of appropriately selected patients respond, often dramatically. However, the HDE pathway only required demonstration of safety, not definitive effectiveness proof. Ironically, after the HDE was granted, utilization decreased: mostly because insurance companies refused to cover the procedure despite the FDA HDE status. Fewer than 50 DBS implants for OCD had been performed via the Medtronic program as of available reports. Medicare coverage remains limited, and most private insurers deny coverage as "experimental."
Attention-Deficit/Hyperactivity Disorder (ADHD)
Digital Therapeutics:
EndeavorRx (Akili Interactive): De Novo granted, June 2020.
The first prescription video-game-based digital therapeutic. For children ages 8-12 with primarily inattentive or combined-type ADHD who have a demonstrated attention deficit. Delivered through an action video game designed to challenge sustained attention. Improvements are measured on computer-based testing (the TOVA test), and may not translate to typical behavioral symptoms. Three-month treatment cycles. Whether the effect is clinically meaningful remains debated, as the minimum clinically important difference for the ADHD attention measures used hasn't been established. Akili now also markets a less expensive non-prescription ("over-the-counter") version for adults.
Multiple FDA Cleared ADHD digital therapeutic devices: Several have received clearance via “substantial equivalence” (similar enough that we don’t have more safety/effectiveness questions) to EndeavorRx as the pre-existing product.
In November 2025, CMS expanded digital mental health treatment reimbursement codes to include ADHD digital therapeutics, effective 2026.
Chronic Insomnia
Digital Therapeutics:
Somryst (now marketed by Nox Health; originally Pear Therapeutics): De Novo granted / FDA Cleared.
Prescription CBT for insomnia (CBT-I) delivered via app for adults 22+. Nine-week treatment course. A caution: sleep restriction components may potentially exacerbate conditions like bipolar disorder.
SleepioRx (Big Health): FDA cleared.
Another prescription CBT-I app for chronic insomnia.
Substance Use Disorders (SUD)
Digital Therapeutics:
reSET (originally Pear Therapeutics; now PursueCare): De Novo granted, September 2017.
The first FDA-authorized computerized therapy device in psychiatry. A prescription CBT-based app for substance use disorders (not for patients on opioid replacement therapy, not for those who abuse only alcohol or primarily opioids).
reSET-O (PursueCare): FDA Cleared. For opioid use disorder specifically, as an adjunct to outpatient treatment including transmucosal buprenorphine and contingency management.
Important note: Pear Therapeutics, the original developer of reSET, reSET-O, and Somryst, declared bankruptcy in 2023 after payors refused to cover these products despite their FDA statuses. The products have been acquired by other companies and remain on the market, but this history illustrates the commercial fragility of digital therapeutics.
Postpartum Depression
Digital Therapeutics:
MamaLift Plus (Curio Digital Therapeutics): FDA Cleared April 2024.
First FDA-cleared prescription digital therapeutic for postpartum depression (mild to moderate). For adults 22+, as an adjunct to clinician-managed outpatient care. Uses elements of CBT, DBT, behavioral activation, and interpersonal therapy. Self-guided, interactive treatment modules for daily use over 8-9 consecutive weeks. The SuMMER trial (n=141) showed 86.3% of the treatment group achieved meaningful EPDS improvement vs. 23.9% in control.
Conditions Where DBS Has a Psychiatric HDE or Is Under Active Investigation
Tourette's Syndrome: DBS is being studied but does not currently have a specific FDA authorization for this indication.
Treatment-Resistant Depression: Despite promising open-label data, DBS has not received FDA authorization for depression. Multiple targets (subcallosal cingulate, nucleus accumbens, ALIC) have been studied, and larger trials continue.
What's NOT on This List (And Why)
Several important categories of non-medication treatment have not gone through the FDA process, even though many have substantial evidence:
Psychotherapy (CBT, DBT, EMDR, psychodynamic therapy, etc.): Psychotherapy is not a "device" or "drug" and doesn't go through FDA authorization. It is evidence-based and is the standard of care for many conditions.
Exercise: Fairly good evidence for depression, anxiety, and ADHD, but no one is really paying to push an exercise protocol through the FDA.
Light therapy: Well-established for seasonal affective disorder and an adjunct for non-seasonal depression. Light boxes are available for purchase, but the specific therapeutic use doesn't typically go through FDA clearance as a treatment device.
Dietary and nutritional interventions: Omega-3 fatty acids, Mediterranean diet approaches, etc. have accumulating evidence but do not go through the FDA as treatments. Supplements and dietary lifestyle habits don’t count as “food” per se (“food” and “drug” administration).
Meditation/mindfulness programs: Large evidence base, not FDA regulated.
Neurofeedback: Many systems and protocols exist; evidence is variable. Some neurofeedback devices are FDA registered as biofeedback tools, but generally not specifically cleared or approved for treating specific psychiatric diagnoses.
This is the financial incentive problem in action. The FDA process inherently favors treatments that can be patented, monetized, and sold as products. It’s also a scope issue: it is the “food” and “drug” administration after all, which doesn’t quite reflect what the breadth of what we’re using now. That doesn't mean unpatentable treatments are less valid (necessarily) but it also means they don't have a company investing millions to prove them through a specific regulatory pathway.
Where to Stay Up to Date
This landscape changes rapidly. Here are the best resources I've found for staying current:
FDA's CDRH (Center for Devices and Radiological Health) databases:
Devices@FDA searchable by product name or company
The Digital Therapeutics Alliance (DTA) Industry organization that tracks the DTx landscape.
Society for Digital Mental Health Academic society focused on evidence-based digital interventions; has been advocating for broader CMS coding for non-FDA-cleared tools as well.
John Torous's group at Beth Israel Deaconess / Harvard The Division of Digital Psychiatry publishes regularly on the evidence base for digital mental health tools. Their 2025 Mental Health Research paper tracing the regulatory lineage of mental health SaMD is especially worth reading.
APA Services (American Psychological Association) Published a helpful November 2025 overview on reimbursement pathways for digital therapeutics.
Psychopharmacology Institute Publishes annual year-in-review summaries of FDA approvals relevant to psychiatry (including devices).
SAMHSA Published a 2023 Advisory on digital therapeutics for behavioral health management and treatment.
CMS New Codes: In November 2024, CMS approved three new reimbursement codes for digital mental health treatments, effective January 2025. In November 2025, these were expanded to include ADHD digital therapeutics (effective 2026). In September 2025, Cigna announced coverage for FDA-approved digital therapeutics, a commercial insurance milestone.
Bottom Line for Clinicians
We are in an early, exciting, and somewhat chaotic era for non-medication FDA-authorized psychiatric treatments. A few takeaways:
Know the regulatory terminology. When a rep tells you something is "FDA approved," ask which pathway. Cleared ≠ Approved ≠ Granted ≠ HDE. The evidence requirements differ substantially.
Evaluate the evidence independently. FDA clearance through 510k pathway based on predicate equivalence does not guarantee that the specific marketed product has been tested in an RCT. Check the actual trial data.
Talk to patients about what "FDA approved" means and doesn't mean. It doesn't mean it's the best treatment. It doesn't mean insurance will cover it. And treatments that haven't gone through the FDA process aren't necessarily always ineffective.
Keep the financial reality in context. The absence of an FDA-reviewed treatment for a given condition often reflects economic barriers, not lack of efficacy.
Watch the reimbursement landscape. The new CMS codes and early commercial insurer coverage (Cigna, CVS Health) may be the tipping point for broader adoption of digital therapeutics.
This is a space worth watching - and worth integrating thoughtfully, with appropriate clinical judgment, into the toolkit we offer our patients.
Have I missed something? Is there an FDA-approved, -cleared, or -granted non-medication psychiatric treatment not on this list? I'd love to hear from you. Reach out at patriciapopmd.com.
Sources & Key References:
FDA, Center for Devices and Radiological Health. "Regulatory Considerations for Digital Mental Health Therapeutics." Presentation by Pamela Scott, November 6, 2025.
Herpertz J, Stern AD, Opel N, et al. "FDA-authorized software as a medical device in mental health: a perspective on evidence, device lineage, and regulatory challenges." npj Mental Health Research. 2025;4:62.
Makower J, Meer A, Denend L. "Estimated Cost of Developing a Therapeutic Complex Medical Device in the US." JAMA Network Open. 2022;5(9):e2231609.
Moore TJ, et al. "Estimated Costs of Pivotal Trials for Novel Therapeutic Agents Approved by the US FDA, 2015-2016." JAMA Internal Medicine. 2018.
APA Services. "New reimbursement pathways have opened doors for using digital therapeutics." November 12, 2025.
Malleza S, Guzmán F. "2025 in Review: FDA Approvals, Practice Guidelines, and Label Changes in Psychiatry." Psychopharmacology Institute. December 18, 2025.
SAMHSA. "Advisory: Digital Therapeutics for Management and Treatment in Behavioral Health." 2023.