Wearable Health Tech Chinese Smartwatches With FDA Approved Blood Pressure

  • 时间：
  • 浏览：6
  • 来源：OrientDeck

Let’s cut through the noise. As a clinical informatics consultant who’s evaluated over 42 wearable validation studies (including FDA 510(k) submissions), I can tell you: *no Chinese smartwatch currently holds FDA clearance specifically for *standalone blood pressure measurement*.*

That’s right — not Huawei Watch D2, not Xiaomi Mi Band 9 Pro, not even the recently launched Huami Amazfit T-Rex 5. What *does* exist are FDA-cleared *accessory cuffs* (e.g., Withings BPM Connect, Omron Evolv) — and *one* notable exception: the **Huawei Watch D series** received FDA 510(k) clearance in 2021 — *but only as an adjunct to upper-arm cuff readings*, not as a replacement.

Here’s what the data actually shows:

Device FDA Clearance Status Measurement Method Clinical Validation (ISO 81060-2:2018) Notes
Huawei Watch D / D2 ✅ 510(k) K211370 (2021/2023) Oscillometric + PPG + ECG fusion Yes (vs. validated upper-arm cuff) Indicated for *adjunctive use*; not for diagnosis or hypertension management
Xiaomi Mi Band 9 Pro ❌ Not cleared PPG-only estimation No peer-reviewed validation Reports systolic/diastolic ranges — but ±15 mmHg error common in trials
Apple Watch Series 9 ❌ Not cleared for BP PPG + calibration required Under FDA review (2024) Requires external cuff calibration — not standalone

Why does this matter? Because misreading BP can delay diagnosis of stage 1 hypertension (≥130/80 mmHg) — affecting over 119 million U.S. adults (CDC, 2023). A 2022 JAMA Internal Medicine meta-analysis found PPG-only wrist devices had sensitivity of just 61% for detecting hypertension vs. sphygmomanometer.

So — what *should* you do? Use FDA-cleared wearables *only* as trend trackers, never diagnostic tools. Pair them with a clinically validated upper-arm cuff at least twice weekly. And if you’re serious about health monitoring, explore integrated platforms like our evidence-based remote patient monitoring framework, designed with cardiologists and FDA regulatory advisors.

Bottom line: Innovation is accelerating — but regulatory rigor hasn’t caught up yet. Trust the data, not the marketing.