FDA clears mental‑health digital treatments

The Food and Drug Administration has now cleared one prescription app for anxiety and approved one at-home brain-stimulation device for depression, extending regulated mental-health treatment beyond pills and office visits. (fda.gov; fda.gov) DaylightRx, made by Big Health, was cleared on August 30, 2024, under the Food and Drug Administration’s device pathway for computerized behavioral therapy devices for psychiatric disorders. The clearance allows it to be marketed for generalized anxiety disorder as an adjunct to usual care in adults age 22 and older on the order of a licensed health care provider. (fda.gov; bighealth.com) The depression device, Flow FL-100, won premarket approval on December 8, 2025, for adults 18 and older with moderate to severe major depressive disorder in the current episode who are not considered treatment refractory to medication. The Food and Drug Administration said it can be used either alone or alongside other treatment. (fda.gov) DaylightRx is a software treatment built around cognitive behavioral therapy, a talk-therapy method that teaches patients to challenge worry patterns and change routines that reinforce anxiety. Big Health says the treatment is delivered through video and audio lessons in a mobile app and is prescription-only in the United States. (bighealth.com; psychiatrictimes.com) Flow FL-100 is a headset that sends a low direct electrical current through scalp electrodes to target brain areas involved in mood regulation. The Food and Drug Administration’s summary says the device delivers 2.0 milliamps of transcranial direct current stimulation and connects to a smartphone by Bluetooth. (fda.gov) The evidence packages were not the same. DaylightRx came through the 510(k) clearance process used for many moderate-risk devices, while Flow FL-100 went through premarket approval, the Food and Drug Administration’s stricter route for higher-risk devices. (fda.gov; fda.gov) The Flow decision also came with caveats. The Food and Drug Administration wrote that its review found “a moderate level of uncertainty of benefit” because of unblinding, no prespecified clinically significant change in one depression score, and conflicting results in the literature. (fda.gov) The pivotal Empower trial for Flow enrolled 174 participants in the United States and United Kingdom, with a blinded 10-week phase followed by an open-label phase. ClinicalTrials.gov lists the study as completed, with sites in Houston and London. (clinicaltrials.gov; fda.gov) These products also show how the agency is treating mental-health software and connected devices as medical devices, not wellness apps. The Food and Drug Administration now maintains a Digital Health Center of Excellence and a Digital Health Advisory Committee that in November 2025 discussed generative artificial intelligence-enabled digital mental-health devices. (fda.gov; fda.gov) Neither authorization is specific to pregnancy or postpartum care. The cleared and approved indications cover general adult populations, with DaylightRx starting at age 22 and Flow FL-100 at age 18, so any use in perinatal psychiatry would require separate evidence, labeling, or clinician judgment outside a pregnancy-specific indication. (fda.gov; fda.gov) What happens next is less about a single app or headset than about follow-through: prescriptions, reimbursement, clinician uptake, and postmarket safety reporting. The Food and Drug Administration’s orders let both products be sold, but the real test now is whether patients and clinicians use them in routine care. (fda.gov; fda.gov)