What the FDA said
On September 16, 2025, the FDA published a safety communication titled Do Not Use Unauthorized Devices for Measuring Blood Pressure. The agency told consumers, patients, and caregivers not to use unauthorized blood pressure devices, including software features on wearables such as smartwatches and smart rings, that claim to measure blood pressure.
The FDA stated that the safety and effectiveness of unauthorized devices have not been reviewed by the agency and that inaccurate blood pressure measurements could lead to inappropriate medical decisions or delayed treatment. That is factual regulatory guidance, not a brand comparison.
What “unauthorized” means
In this context, unauthorized means the blood pressure measuring device or feature has not gone through the FDA pathway needed for that medical use. A watch may be useful for many non-medical wellness features, but a blood pressure claim is different because people may use the number to make health decisions.
The FDA also directed consumers to check the FDA 510(k) database when they want to know whether a blood pressure device has been evaluated and authorized. For home use, that regulatory status is only one piece of the picture; proper technique and validation also matter.
| Device or feature type | What to check | Plain-language takeaway |
|---|---|---|
| Wearable blood pressure feature | Whether the specific BP feature is FDA-authorized | Do not assume a wellness wearable can replace a blood pressure monitor. |
| Upper-arm cuff monitor | FDA status, validation, cuff fit, and instructions | Cuff-based upper-arm measurement remains the standard home approach. |
| Phone app without hardware | Whether it is only a log or claims to measure BP | A log can record readings; it should not invent readings. |
Why upper-arm cuff measurement remains the standard
The American Heart Association recommends an automatic, cuff-style upper-arm monitor for home monitoring and notes that wrist and finger monitors are less reliable, as explained in its home blood pressure monitoring guidance. For cleared upper-arm devices, clinical accuracy testing to ISO 81060-2 supports a ±3 mmHg accuracy standard under the tested conditions. That does not remove the need for proper cuff fit and technique, but it is a different evidence category than an unauthorized wearable feature.
How to use wearables responsibly
A smartwatch can still be useful for reminders, activity trends, or general wellness tracking. The key is not to treat an unauthorized blood pressure feature as the measurement your doctor should rely on. If blood pressure monitoring matters for your care, use an appropriate cuff-based device, follow a consistent technique, and bring your readings to your appointment.
For related reading, see wrist vs upper-arm blood pressure monitors, what FDA-cleared means, and the barrel-style monitor comparison page.
A wearable can still be useful as a reminder, but log cuff-based readings separately. The TrueVitals BP Journal is free for TrueVitals customers and gives you one place to keep those readings organized.
FAQ
Did the FDA ban smartwatches?
No. The FDA safety communication warned against using unauthorized devices or wearable software features that claim to measure blood pressure. It was about blood pressure measurement claims, not every smartwatch function.
What does unauthorized mean for blood pressure devices?
It means the FDA has not reviewed that device or feature for the claimed blood pressure measurement use.
Are upper-arm monitors always accurate?
They still need proper cuff fit, posture, and technique. But a validated, FDA-cleared cuff-based upper-arm device is the standard category for home blood pressure monitoring.
Can I use a smartwatch as a blood pressure log?
Using a smartwatch or app to remind you or store readings is different from relying on an unauthorized feature to measure blood pressure. Bring actual cuff-based readings to your clinician.
For a page-level comparison of wearable estimates and cuff-based barrel-style measurement, see barrel-style monitors vs. blood pressure smartwatches.
About TrueVitals
If the takeaway is that cuff-based upper-arm measurement remains the standard, that is the product category addressed here. The TrueVitals Pro is FDA-cleared (510(k) K251102), clinically tested to the ISO 81060-2 accuracy standard (±3 mmHg), and uses a barrel-style/no-wrap arm-in design with auto-fit 7.1–16.5 in (18–42 cm), one-touch operation, no app required, dual-user memory, rechargeable power, and a large backlit display. See the TrueVitals Pro →