What your smartwatch is actually cleared to tell you

The short version

For most of the past decade, “health features” on a smartwatch meant step counts and a heart-rate graph with no regulator anywhere near them. That has genuinely changed. In Australia, three categories of wearable health feature now sit on the Australian Register of Therapeutic Goods as software medical devices: electrocardiogram and irregular-rhythm notifications, sleep apnoea risk detection, and — since January 2026 — hypertension notifications.

Everything else your watch shows you — readiness, stress, body composition, antioxidant scores, “vascular load” — is a wellness feature. That is not an insult; some of it is genuinely useful. It just means no regulator has assessed whether the number means what the marketing says it means. Knowing which side of that line a feature sits on is the single most useful thing you can learn before spending money on a health wearable.

1. Hypertension notifications: the newest one, and the most interesting

Apple’s hypertension notification feature was approved by the Therapeutic Goods Administration in December 2025 and switched on for Australian users on 28 January 2026. It needs an Apple Watch Series 9 or later, or an Ultra 2 or later, running watchOS 26 with an up-to-date iPhone.

The important thing to understand is what it does not do: it does not measure your blood pressure. There is no cuff and no number. The optical heart sensor analyses how your blood vessels respond to each heartbeat, passively, across rolling 30-day periods. If that pattern consistently looks like hypertension, you get a notification — and the Health app then asks you to log real cuff readings for seven days and take them to your doctor. Apple says the underlying model was trained on data from more than 100,000 participants and validated in a clinical study of more than 2,000.

The exclusions are as informative as the feature. It is not intended for anyone under 22, anyone already diagnosed with hypertension, or anyone pregnant, and Apple states plainly that it will not detect all instances of hypertension. Professor Garry Jennings, chief medical advisor at the Heart Foundation, welcomed the approval while making the obvious but frequently ignored point: silence from your watch is not evidence that your blood pressure is fine.

Why it matters here specifically: AIHW analysis of the ABS 2023 National Health Survey (2022 reference period) estimates 39% of Australians aged 18 and over — roughly 7.2 million adults — have hypertension, and that 63% of them did not self-report having it. A passive nudge toward a GP is aimed squarely at that awareness gap. Apple has projected the feature will notify more than a million people with undiagnosed hypertension worldwide in its first year.

2. Sleep apnoea: approved here since May 2025

Australia cleared both major implementations within about a week of each other in May 2025 — Samsung’s first, then Apple’s on 29 May. They work differently, and the difference is worth knowing.

• Apple uses the watch’s accelerometer to track small wrist movements associated with breathing disturbances during sleep, then analyses that data on a monthly cycle. Series 9, Series 10 and Ultra 2, users 18 and over.
• Samsung takes the blood-oxygen route, looking for moderate-to-severe obstructive sleep apnoea across a two-night window through Samsung Health Monitor. Galaxy Watch4 and later, users 22 and over.

Neither diagnoses anything. Both are screening prompts, and both companies say so explicitly. That is still valuable: sleep apnoea is common and heavily under-detected, and sleep physicians quoted at the time of approval framed the appeal simply — anything that gets people to a doctor earlier, before the cardiovascular complications arrive, is worth having.

One 2026 development to watch, with a caveat: at its July 2026 Unpacked, Samsung announced that the Galaxy Ring will become the first over-the-counter smart ring with FDA-cleared sleep apnoea risk detection, expected to roll out later this year. That is a US clearance announcement. It says nothing about Australian availability, and TGA approval is a separate process — do not assume the feature will appear here on the same timetable.

3. ECG and blood pressure: the older approvals people forget

ECG is the veteran. Apple’s ECG and irregular-rhythm notifications reached Australian users in May 2021; Samsung’s TGA-approved ECG on the Galaxy Watch4 followed from 10 September 2021, working through the Samsung Health Monitor app when paired with a compatible Galaxy phone.

Samsung’s cuff-calibrated blood pressure feature is the odd one out and the one most often misunderstood. Unlike Apple’s notification approach it does produce a number — but only after calibration against a real cuff, and it drifts, so recalibration is required. Samsung’s own Australian support documentation carries a long list of people it is not for: under-22s, pregnant users, and anyone with arrhythmia, heart failure, a history of heart attack, peripheral vascular or valve disease, cardiomyopathy, end-stage renal disease, diabetes, neurological or clotting disorders, or taking blood thinners. It also warns that a wrist tattoo under the sensor can prevent readings, and asks users to avoid alcohol, caffeine, nicotine, exercise or a bath for 30 minutes beforehand.

Read that list again. It rules out a large share of exactly the population most interested in tracking their blood pressure. This is a genuinely clever feature with a narrow eligible audience.

What is definitively not cleared: blood glucose

If a watch, band or ring claims to measure your blood sugar without piercing the skin, walk away. The FDA has never authorised, cleared or approved any smartwatch or smart ring that measures or estimates blood glucose non-invasively, and issued a public safety communication in February 2024 warning consumers off them after finding dozens of companies selling such devices. False readings used to guide insulin dosing are a serious-harm scenario, not a minor inaccuracy. Legitimate continuous glucose monitors use a skin sensor; a watch may display their data, but it is not the thing doing the measuring.

The grey zone: wellness scores

Between “approved medical device” and “dangerous claim” sits the large and growing category of wellness metrics, which regulators generally leave alone because they are not marketed as diagnosing disease.

Samsung’s Galaxy Watch8 and Watch Ultra, for example, added an Antioxidant Index that uses multi-wavelength absorption spectroscopy to read skin carotenoids in about five seconds and returns a 0–100 score reflecting fruit and vegetable intake, plus a Vascular Load metric derived from overnight PPG waveforms. Oura, meanwhile, has always positioned its ring as a wellness product rather than a medical device — and is now working through the formal pathway for a blood-pressure feature, launching a Blood Pressure Profile study in Oura Labs in December 2025 to validate it.

The honest way to treat these numbers is as trend lines about yourself, not measurements about your body. A carotenoid score going up over a month probably does say something about your diet. A single reading says very little, and none of it has been assessed by the TGA.

How to check a claim yourself

Two practical habits. First, the phrase to look for is not “clinically validated” or “medical-grade” — both are marketing language with no fixed meaning. It is “included in the ARTG” or “TGA-approved”, and you can search the Australian Register of Therapeutic Goods yourself, free, to confirm it. Second, check the exclusion list before the feature list. Every one of these approvals comes with an age floor, a set of conditions it is not for, and an explicit statement that it does not replace diagnosis. Those constraints are the most accurate description of the feature you will find anywhere in the box.

The bottom line

A 2026 smartwatch can plausibly flag an irregular rhythm, nudge you toward a sleep study, and tell you your blood-vessel behaviour looks like hypertension — all of which are real, regulator-assessed capabilities that did not exist on the wrist a few years ago. What it still cannot do is measure your blood sugar, replace a cuff for most people, or tell you that you are healthy. Buy for the screening prompts, ignore the scores, and treat every notification as a reason to book an appointment rather than an answer.

Sources

Facts and dates above are drawn from these primary and reputable sources, captured July 2026:

• Apple Newsroom (AU) — Hypertension notifications available today on Apple Watch (28 January 2026)
• Information Age (ACS) — Apple Watch blood pressure alerts launch in Australia (28 January 2026), including Heart Foundation comment and TGA/ARTG timing
• Information Age (ACS) — Australia approves Apple, Samsung sleep apnoea tech (30 May 2025)
• Samsung Newsroom Australia — Blood pressure tracking and TGA-approved ECG on Galaxy Watch
• Samsung Australia — Restrictions on blood pressure tracking with Samsung Health Monitor
• Australian Institute of Health and Welfare — Hypertension in Australia, summary (ABS National Health Survey, 2022 reference period)
• US FDA — Do not use smartwatches or smart rings to measure blood glucose levels (safety communication, February 2024)
• Samsung Newsroom — how the Galaxy Watch sensor measures skin carotenoids and vascular load
• MedTech Dive — Ōura to pursue FDA clearance of blood pressure feature for smart ring
• Ubergizmo — Galaxy Ring to become first smart ring with FDA-cleared sleep apnoea detection (24 July 2026, US clearance)