Desk

Digital mental health

Telehealth psychiatry, therapy apps, AI mental health, digital therapeutics.

DIGITAL HEALTH · ANALYSIS

The first FDA-authorized treatment for schizophrenia's negative symptoms is an app. The evidence is narrower than "first" suggests.

FDA cleared Click Therapeutics' Motivista on July 30 as the first treatment specifically indicated for negative symptoms of schizophrenia, a category no drug occupies. The pivotal trial, published September 25, found a 2.6-point advantage over a control app on a 36-point clinician-rated scale. Patients' own ratings did not differ significantly at 16 weeks, a planned measure of functioning has not been reported, and Click has disclosed no launch date, price, or coverage.

By Editorial Desk · Oct 5, 2026 · 10 min read
DIGITAL HEALTH · ANALYSIS

How Medicare's ACCESS model changes the economics of AI-delivered mental health care

Medicare's ACCESS model pays participating organizations up to $180 a year to treat a beneficiary's depression or anxiety, holds back half, and reconciles it against symptom-score outcomes across the provider's patient panel. It sets no visit count. One participant delivers structured CBT through an AI voice agent admitted to an FDA pilot that has not evaluated the device's effectiveness. Medicare still pays the licensed provider, not the software, but the unit of payment is no longer the human encounter.

By Editorial Desk · Oct 4, 2026 · 10 min
DIGITAL HEALTH · ANALYSIS

Aiming TMS at the brain activity behind hallucinations beat the standard scalp target. It is a different test from the one personalized depression stimulation failed.

In MULTIMODHAL, a two-center French trial now in its second preprint version, 1-Hz rTMS aimed with a hallucination-capture fMRI scan reduced auditory hallucination severity more than the same stimulation placed by scalp landmark. Both arms got active stimulation, the primary endpoint was changed from the registered one before unblinding, and follow-up past three months thinned sharply.

By Editorial Desk · Sep 30, 2026 · 8 min
DIGITAL HEALTH · ANALYSIS

No medication or device is FDA-authorized for stimulant use disorder. NET Recovery just received a faster review path for one.

NET Recovery's neurostimulation device is FDA-cleared for opioid withdrawal on the strength of a sham-controlled trial. The only public evidence for its new stimulant-use-disorder indication is an uncontrolled real-world study, whose own authors recommend a sham-controlled trial as the next step; NET Recovery has not disclosed whether that study supported its Breakthrough Device Designation application, or what evidence did. The company says it is designing a pivotal randomized controlled trial, but has not disclosed whether it will include a sham arm.

By Editorial Desk · Sep 24, 2026 · 7 min
DIGITAL HEALTH · ANALYSIS

Pelago is putting AI at the front of its new behavioral health platform. The evidence for its care-routing model is still incomplete.

Pelago is bringing substance-use care, mental health, and behavioral addictions onto one employer platform, with Sona assessing members under clinical supervision. The company has published economic evidence for its existing substance-use program, including one peer-reviewed study, but its reported Sona outcomes come from observational studies that do not establish the accuracy of the new platform's care-routing decisions.

By Editorial Desk · Sep 23, 2026 · 9 min
DIGITAL HEALTH · ANALYSIS

A sham-controlled test of personalized brain stimulation for depression found nothing. The trial that found a benefit never tested against sham.

A UC San Diego trial of connectivity- and frequency-individualized accelerated theta-burst stimulation for treatment-resistant depression found no significant separation from sham on its primary or secondary endpoint. That complicates a personalization narrative another widely covered 2026 neuromodulation trial appeared to establish this year, one built entirely without a placebo arm.

By Editorial Desk · Sep 18, 2026 · 8 min
DIGITAL HEALTH · MARKETS

The first FDA-approved at-home depression device goes on sale in the US, nine months after approval

Flow Neuroscience's FL-100 headset is the only tDCS device with a completed FDA premarket approval for depression; its closest rivals are still in investigational trials. The commercial launch adds a prescription and telehealth pathway to that approval. It does not add a price, an insurance answer, or independent data on how the device performs outside a clinical trial.

By Editorial Desk · Sep 17, 2026 · 5 min
DIGITAL HEALTH · RESEARCH

BrainsWay's Alzheimer's depression pilot found an 83% response rate, no control group

Twelve patients with depression and early Alzheimer's disease got 36 sessions of Deep TMS, and most improved. The brain-activity changes researchers measured are worth taking seriously. The absence of any comparison group means the headline response and remission numbers can't yet be trusted on their own.

By Editorial Desk · Sep 8, 2026 · 6 min
DIGITAL HEALTH · ANALYSIS

NAMI is building an evaluation standard AI mental health chatbots don't have yet

No regulator currently certifies whether an AI chatbot is safe to use for mental health support. NAMI's expanded partnership with digital psychiatry researcher John Torous, and the live MindBench.ai platform it has already produced, is building that evaluation infrastructure directly, ahead of any formal regulatory framework.

By Editorial Desk · Aug 20, 2026 · 8 min
DIGITAL HEALTH · ANALYSIS

Osmind just became a partner in one ketamine company's success. It also holds the data on all its competitors.

The real-world-evidence platform behind more than a thousand independent psychiatry practices administering ketamine and esketamine today has signed a multi-year deal to help Tasman Therapeutics design its Phase 3 trial and build its future commercialization infrastructure. Nothing about the deal is improper. It does mark a new kind of player entering psychedelic-adjacent drug development, one whose core asset is neutrality, now tied by a multi-year partnership to a single company's outcome.

By Editorial Desk · Aug 12, 2026 · 7 min
DIGITAL HEALTH · ANALYSIS

Three separate device trials, three different technologies, one converging story: neuromodulation psychiatry is giving up on one-size-fits-all

A targeting trial in TMS, a statistical test built for a tDCS headset, and an autonomic-biomarker study in deep brain stimulation have nothing to do with each other on paper. Read together, they describe the same shift happening in parallel across neuromodulation's major device categories: away from asking whether a device works in aggregate, and toward asking for whom, through what mechanism, and how confidently anyone can tell the difference between a real effect and a confound.

By Editorial Desk · Jul 24, 2026 · 9 min
DIGITAL HEALTH · ANALYSIS

At-home ketamine's largest dataset reports strong results. Six of seven authors are paid by the company it studies.

A retrospective analysis of 3,041 Mindbloom patients reports high rates of clinical improvement from at-home subcutaneous ketamine, a genuinely under-studied delivery route. The topline numbers are real. So is the conflict of interest, the near-total attrition by the final assessment, and the gap between the headline improvement rate and the much lower remission rate underneath it.

By Editorial Desk · Jul 21, 2026 · 8 min
DIGITAL HEALTH · ANALYSIS

A device trial finally tested whether unblinding actually biased the result, instead of just admitting it happened

Every neuromodulation and psychedelic trial this desk covers eventually runs into the same problem: patients can often tell whether they got the real treatment. A new analysis of a home-use tDCS depression trial does something most studies don't bother with, it empirically tests whether that broken blind actually distorted the outcome, rather than treating unblinding and bias as the same thing.

By Editorial Desk · Jul 16, 2026 · 6 min
DIGITAL HEALTH · ANALYSIS

A new study maps New York's off-label ketamine advertising market. The prior baseline found false claims in nearly half of it.

Researchers have systematically catalogued clinics using direct-to-consumer advertising to sell off-label ketamine in the New York metro area, the densest such market yet studied. A comparable study elsewhere found extensive misrepresentation of the drug's approval status and risks. The empirical baseline now exists. What regulators do with it is the open question.

By Editorial Desk · Jul 2, 2026 · 6 min
DIGITAL HEALTH · ANALYSIS

The quiet infrastructure decision that will shape community behavioral health: who gets to accredit the clinics.

SAMHSA has opened a comment period on building an independent accreditation system for the federal Certified Community Behavioral Health Clinic expansion program, a 500-clinic, now-permanent Medicaid benefit. The design choices being written now, who accredits, what the standards are, and whether failing costs grant money, will set the operating economics for a large slice of the behavioral-health-services sector.

By Editorial Desk · Jun 27, 2026 · 6 min
DIGITAL HEALTH · ANALYSIS

A trial says the expensive way to aim TMS is worth it. That reshapes how the treatment scales.

A JAMA Psychiatry randomized trial found that aiming accelerated TMS with individual brain imaging beat the standard scalp-landmark method, an 80 percent response rate against 60. It is the strongest evidence yet that the personalized approach earns its cost, which pushes the fastest-growing depression neuromodulation toward precision, expense, and the imaging-capable centers that can deliver it.

By Editorial Desk · Jun 25, 2026 · 6 min
DIGITAL HEALTH · REGULATION

Rhode Island's two-track rulebook for AI in mental health is now law.

One law governs AI used in clinical treatment. Another sets safety rules for companion chatbots. Signed together on June 22, 2026, they form a govern-it model other states are watching as the alternative to an outright ban.

By Editorial Desk · Jun 7, 2026 · 6 min
DIGITAL HEALTH

Prescription digital therapeutics and the HCPCS codes that will define the category

CMS's January 2025 creation of three Medicare reimbursement codes for digital mental health treatment is the most consequential thing that has happened to the prescription digital therapeutics market since the FDA started clearing them. The codes' narrow scope is doing more to shape the field than the clearances themselves.

By Editorial Desk · Jun 5, 2026 · 8 min
DIGITAL HEALTH

Digital mental health didn't get disrupted. It got absorbed.

Hims and Hers, the category's public bellwether, grew 4 percent last quarter and swung to a loss. The growth now comes from branded weight-loss drugs and overseas expansion. Mental health is one specialty on a platform that has stopped being about mental health.

By Editorial Desk · Jun 4, 2026 · 6 min

In the pipeline

Full pipeline →
ProgramSponsorPhaseStatus
CT-155Negative symptoms of schizophrenia (adults 18+); adjunct to outpatient care Click Therapeutics Approved FDA 510(k)-cleared July 30, 2026 (K254038, Motivista); Click Therapeutics announced the clearance Oct 5, 2026 and says the product is being prepared for broader commercial availability
RejoynMajor depressive disorder (adjunct) Otsuka / Click Therapeutics Approved FDA 510(k)-cleared March 30, 2024 (K231209)
Sleepio / DaylightChronic insomnia (adults 18+) and generalized anxiety disorder (adults 22+); adjunct to usual care Big Health Approved FDA 510(k)-cleared prescription digital CBT: Sleepio (K233577, Aug 5, 2024) and Daylight (K233872, Aug 30, 2024); marketed as SleepioRx and DaylightRx