For how we live.
Rejoyn, the first prescription digital therapeutic cleared for major depression, beat a sham app on a backup analysis. Its pre-specified primary endpoint fell just short of significance.
EndeavorRx is a prescription game the FDA cleared in 2020 for children with ADHD. Its pivotal trial moved a computer attention score, but the FDA says it may not help the behaviour parents notice.
In a 64-patient randomised trial, home cardiac rehab monitored by a smart ring improved fitness. But both arms wore the ring; what separated them was a weekly call from a clinician.
RelieVRx is an authorised virtual-reality therapeutic for chronic low back pain. Its trials show real improvement — but in a 1,067-person study the edge over a placebo headset was 0.4 points on a 10-point scale.
In a 230-patient randomised trial, self-guided app hypnotherapy produced a 33% pain response versus 48% with an in-person therapist and 22% with education — falling short of non-inferiority.
A smartphone app delivering CBT cut tinnitus-related distress about 20 points more than a sham app in 60 adults, and the effect held for two months. The trial was small and industry-funded.
A 2025 rule created billing codes for FDA-cleared mental-health software. The 2026 rule adds short-episode remote-monitoring codes but declines to widen the digital-therapy benefit.
In 216 patients with chronic patellofemoral pain across 10 Korean hospitals, an 8-week digital therapeutic beat education and exercise instruction on pain — by 12.5 mm on a 100 mm scale.
Thirty-two interviews across Uruguay, Argentina, Chile and Mexico find implementation turned on governance, not software. A separate patent analysis shows where digital therapeutics are not being built.
In a study of 543,167 cycles, calendar-based apps misclassified a fertile day as safe in two-thirds of cycles. Apps that track a real biological signal do better, but plain calendar apps remain the most common kind.
A new structured dataset finally makes the approvals countable. Two trials published weeks apart show why counting them says little: 0.86 fewer migraine days in one, a 20-point symptom shift in the other.
reSET, Somryst and EndeavorRx cleared a real regulatory bar, on real trial data. The pivotal ADHD game moved an attention score by 0.88 of a point. Clearance is not the obstacle the category keeps hitting — payment is.
Germany's DINKS trial is one of the largest randomised tests of a reimbursable digital therapeutic. The effect is big, the comparator is usual care alone, and the sponsor made the app.
Across 40 trials, self-guided apps moved panic severity modestly and barely touched fear-related cognitions. Clinician-guided versions moved both — which complicates the scalability pitch.
In 311 adults aged 55 to 95, remission rates were 40% and 51% in the two intervention arms at one year, against 16% for online patient education. Adding human support helped a little.