For how we live.
A final order published 9 October classifies the over-the-counter infant pulse rate and oxygen saturation monitor as class II, with special controls built around the risk that it fails to detect a pulse.
A final order codifies Class II status for high-throughput DNA sequencing systems that detect germline mutations in cancer genes, built on Invitae's panel. It becomes a predicate other makers can clear against.
A final order codifies a new Class II category for systems that destroy soft tissue with sound rather than heat, built on HistoSonics Edison System. It becomes a predicate other makers can clear against.
A final order published 17 September denies a petition that sought to exempt four classes of computer-aided detection, diagnosis and triage devices from 510(k) clearance. Makers must keep filing before they market.
The FDA logged the recall of 8,939 StatStrip Glucose and B-Ketone meters on 23 September, after a software flaw let a scanned barcode linger and file a reading to the wrong patient. It is the agency's most serious tier.
A final order classifies the flushing and storage solution for vascular autografts as Class II with special controls, codifying a 2023 De Novo decision on Marizyme's DuraGraft and setting the bar for future copies.
A new draft guidance sets out the agency's current thinking on the non-clinical and clinical data it expects in premarket submissions for robotically-assisted surgical devices. Comments are due 24 November.
Since 2024 the FDA has cleared over-the-counter CGMs for people who don't use insulin. The first independent accuracy check in adults without diabetes finds the sensors track the trend but miss the exact number.
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.
Software that interprets cardiotocography in labour lifts clinicians' accuracy in reader studies. The largest randomised trial of computerised interpretation, in 47,062 women, found no benefit for mothers or babies.
The Hypotension Prediction Index warns anaesthetists before blood pressure falls. Three 2026 trials find a plain mean-pressure alarm does the same job, and the algorithm's benefit tracks how hard clinicians treat.
TRICORDER put an AI-enabled stethoscope into UK primary care. Over a year it did not increase heart-failure diagnoses population-wide, even though the device, when actually used, flagged more disease.
Every low-dose CT for lung cancer also images the heart. A 323-scan study found an AI tool matched expert calcium scoring almost exactly — and separate data show why that number carries weight.
Rings and watches sold online promise needle-free glucose readings. The FDA says do not use any of them, and even research-grade non-invasive sensors miss the mark by about a fifth.
A multicentre reader study found AI raised early-career dentists' caries sensitivity from 67% to 82% without more false positives. Independent testing shows the same tools still miss early lesions.
Wrist and body sensors detect roughly 9 in 10 tonic-clonic seizures. A 192-patient validation against video-EEG found the harder focal seizures still slip past, or bury the alarm in false alerts.
Contactless photoplethysmography turns an ordinary camera into a heart-rate monitor, and pooled studies show it tracks pulse well. Oxygen, respiration and the stress scores layered on top rest on far thinner evidence.
Commercial software reads an X-ray for breaks about as well as a radiologist. A prospective paediatric emergency study found that accuracy did not translate into fewer missed-fracture recalls.
Smart rings and watches measure peripheral skin temperature and report drift from your own baseline, not a thermometer reading. That makes them decent trend sensors and poor fever detectors.
A prescribed home apnea test can diagnose clear-cut cases, and one under-mattress sensor flagged severe apnea with 86% sensitivity — but both miss milder disease and events a lab would catch.
Toilet seats and mirrors that read your heart and blood pressure are real engineering. The published validation is mostly small, single-lab or company-run — and outcome evidence is absent.
A meta-analysis of consumer neurofeedback found no benefit for cognition, mindfulness or physical health and only a small effect on distress — even though the headbands do record real brain activity.
Self-testing and self-managing warfarin cut clot events by roughly 40%, and self-management also lowered deaths — one of the few at-home tests with randomised evidence of real benefit.
Out-of-office readings predict heart attacks and death better than a clinic measurement, and guidelines now require them to confirm hypertension — but only a validated upper-arm cuff counts.
Automatic fall alerts are mostly tested on staged laboratory falls, with real-world validation in older people rare. A 2026 meta-analysis of fall prediction found high specificity but only moderate sensitivity.
Green-light pulse sensors raise a real concern about melanin, but independent tests find the skin-tone effect small next to device and movement errors — and the validation studies barely include darker skin.
European hypertension specialists found only two wrist-cuff blood pressure watches with validation studies done to established protocols. A sleep group ran a Galaxy Watch against two nights of polysomnography.
Head-to-head against an ECG chest strap, popular optical wrist devices differed substantially, and one graded test found a smartwatch running a couple of beats low with a 28-bpm spread in its limits of agreement.
In a free-living comparison, three devices counted steps within about 18% of a research monitor but one overestimated active-calorie burn by 139%. A lab study found step counts collapse when walking is slow.
An umbrella review of 42 reviews found only two wearable measures — heart rate and atrial fibrillation — with comparably strong support. Getting any device into a trial is harder than buying it.
Smart-ring studies report flagging COVID nearly three days before symptoms and IBD flares weeks ahead. But two-thirds of that research carries a high risk of bias, and clinical usefulness is largely unproven.
Pooled against the sleep lab, finger-worn devices call sleep versus wake at 87% but fall to the mid-60s on light sleep. An Oura meta-analysis found no significant gap on total sleep time.
A network meta-analysis put pooled accuracy for the fertile window at 0.88, best in the three days around ovulation. A wrist-temperature study hit ovulation within three days about 78% of the time.
A February scientific statement declines to recommend the category for clinical decisions. Six weeks earlier, a journal retracted a validation study of a popular consumer model.
A review found wearables gave valid maximal-oxygen-uptake estimates in most studies of untrained and recreational exercisers. A separate meta-analysis pooled a 0.83 correlation, with high variability.
Against an ECG over 536 nights, Oura's heart-rate-variability error was under 8% and Whoop's acceptable, while Garmin and Polar lagged. The recovery scores layered on top stay proprietary and largely unvalidated.
A smartwatch bioimpedance sensor tracked body-fat percentage against DXA with about 14% average error — but muscle-mass agreement was weak, and even sitting versus standing shifted the reading.
A meta-analysis of 26 studies put pooled sensitivity at 95% and specificity at 97%. Samsung and Withings devices performed comparably to Apple — but the numbers come from people already suspected of arrhythmia.