Samsung says they just got U.S. FDA approval for the Galaxy Watch 3’s ECG monitoring app

Samsung says they just got U.S. FDA approval for the Galaxy Watch 3’s ECG monitoring app

Samsung just announced its latest smartwatch, the Galaxy Watch 3, at its second Galaxy Unpacked event of the year. Once again, Samsung made the best smartwatch for Android users, and it doesn’t even run Google’s Wear OS. The Samsung Galaxy Watch 3 packs loads of fitness features, but three of its best health monitoring features won’t be available in every country at launch. That’s because they require approval from the regulatory agencies of every country, and in a surprise announcement on stage, Samsung says that they just got clearance from the U.S. FDA for the Galaxy Watch 3 and Galaxy Watch Active 2’s ECG monitoring app.


“And I’m excited to announce that we have just received the U.S. FDA clearance for [the] Samsung ECG monitor[ing] app,” said Federico Casalegno, SVP of Experience Planning and SDIC. ECG monitoring will allow users to monitor their heart rhythm for irregularities such as atrial fibrillation (Afib), which is one of the leading causes of strokes. Meanwhile, blood pressure monitoring allows users to check for irregularities such as high blood pressure (hypertension) or low blood pressure (hypotension), which are precursors to many other diseases.

Samsung previously announced that they had received clearance from South Korea’s MFDS for blood pressure and ECG monitoring in the country, but the company today repeatedly showed disclaimers that these two features will not be available in the U.S. until they received clearance from the FDA. Apparently, Samsung just managed to receive that clearance for at least ECG monitoring, so we can expect to see that feature roll out soon for the Galaxy Watch Active 2 and Galaxy Watch 3. We don’t know how far along the FDA approval process Samsung is for blood pressure monitoring, though.

Lastly, one of the other health monitoring features of the new Galaxy Watch 3, blood oxygen monitoring, will not be available in every country. Samsung says that the feature is not supported in Japan, Angola, South Africa, Thailand, Iran, Libya, France, Algeria, or Canada. Sp02 monitoring may be available in the other countries where the Galaxy Watch 3 is sold, though we’re not entirely sure of the full regional availability of this feature.

Specifications Samsung Galaxy Watch 3
Dimensions & Weight
  • 41mm: 41.0 x 42.5 x 11.3 mm, 48g
  • 45mm: 45.0 x 46.2 x 11.1mm, 53g
  • 41mm:
    • 1.2″ Super AMOLED
    • Corning Gorilla Glass DX
  • 45mm:
    • 1.4″ Super AMOLED
    • Corning Gorilla Glass DX
Watchband size
  • Large: 22.0 x 130.0 x 9.4mm
  • Small: 20.0 x 115.0 x 9.4mm
Memory 1GB RAM, 8GB internal storage
  • LTE
  • Wi-Fi 802.11 b/g/n, 2.4GHz
  • Bluetooth v5.0
Other features
  • 2 physical buttons
  • Rotating bezel
  • Mic
  • Linear Motor
  • Speaker
  • 8 LED photoplethysmography (PPG)
  • Electrocardiogram (ECG)
  • Accelerometer (up to 32G)
  • Gyroscope
  • Barometer
  • Ambient light
NFC Payments Yes, Samsung Pay
  • 41mm: 247mAh
  • 45mm: 340mAh
Durability 5ATM + IP68/ MIL-STD-810G
OS Tizen Based Wearable OS 5.5
  • 41mm: Mystic Bronze, Mystic Silver
  • 45mm: Mystic Silver, Mystic Black
  • Band: Black Leather, Pink Leather (41mm only)

About author

Mishaal Rahman
Mishaal Rahman

I am the former Editor-in-chief of XDA. In addition to breaking news on the Android OS and mobile devices, I used to manage all editorial and reviews content on the Portal.

We are reader supported. External links may earn us a commission.