For how we live.
Every article we have published on Software As Medical Device, newest first.
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.
Under Article 6, AI that is or sits inside a device already needing an independent safety check counts as high-risk. A 70-study review finds the trouble is overlap with existing device law.
A final order files AI tools that flag possible cardiovascular disease as class II with special controls, letting similar triage software clear via 510(k). The controls require real-world, subgroup-tested validation.
An autonomous AI for diabetic retinopathy hit 87.2% sensitivity in primary care. A smartphone acuity test agreed with a reference chart to within 0.07 logMAR. Both are triage, not diagnosis.
A predetermined change control plan is the FDA's answer to a model that keeps learning: pre-approve a bounded set of future changes, and the manufacturer can ship them without returning for a fresh review.
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.