Years ago, when people heard the term “smartwatches”, they could only think of step trackers. Now, these wearable devices have transformed into EGC monitors, blood oxygen scanners, AFib detectors and even early blood pressure estimators, all at your fingertips (quite literally).
With companies such as Apple, Samsung, Google, Oura and Withings steering more into the health territory, the line between “wellness gadgets” and “medical devices” is getting blurred.
In this new era of wearables, one question matters more than ever: Does your wearable device meet medical standards or should you upgrade?
What’s the Difference Between FDA-Approved Wearables and Consumer Smartwatches?
Consumer smartwatches and other wearable devices measure your metrics such as sleep, activity, recovery, HRV, stress levels, etc., but they are not designed to diagnose or treat medical conditions. Because of this, they largely operate outside of the FDA’s regulatory scope.
The moment a device’s intended use crossed over to medical territory, things change. If a smartwatch claims it can detect AFib, sleep apnea risk or blood pressure estimates, the device is subject to medical regulations.
While the FDA does not have to approve the whole device, it does have to approve these medical features. This is why the Apple Watch is not FDA-approved, but the ECG sensor and AFib detection algorithm had to be cleared by the FDA before launch.
FDA-Approved
FDA approval is the highest level of regulatory scrutiny that requires extensive clinical trials to prove its safety and effectiveness. This is mostly required for high-risk Class III devices.
FDA-Cleared
FDA clearance is the most common category required for wearable devices. It uses the 510(k) pathway and manufacturers must be able to prove that their device meets existing medical device standards.
FDA-cleared features include ECG, hypertension alerts, AFib detection features on Apple Watch, Samsung, Fitbit, etc.
Consumer Wellness Devices
Consumer wellness devices, such as other smartwatches, track every metric that does not fall into a medical category, such as step tracking, calorie tracking, HRV, stress, basic heart rate, etc.
These devices neither claim to diagnose nor treat a disease or medical condition. As long as a device does not make medical claims, it does not require FDA clearance.
How FDA Clearance Works and Why Most Wearables Don’t Have It
Getting FDA clearance is a tedious and expensive task and it is not as simple as filing paperwork. As a result, only a small percentage of consumer wearables today are FDA-cleared.
For most wearable devices, the approval pathway is the 510(k) process. This is the simpler route that requires the manufacturers to show clinical data, safety and prove that the device and its claims are substantially equivalent to a medical grade device.
The most rigorous pathway is the Premarket Approval (PMA), which is used for higher-risk devices. PMA requires robust clinical trials, scientific evidence and long-term safety data because these devices claim to diagnose or treat a person.
FDA-Approved Wearables You Can Buy Today
| Device | FDA Status | Medical Features |
|---|---|---|
| Apple Watch Series 4–9 / Ultra | FDA-cleared | ECG, fall detection, AFib detection, and hypertension detection features |
| Samsung Galaxy Watch | FDA-cleared | ECG, Blood Pressure (USA limited), Irregular Heart Rhythm Notification, Sleep Apnea |
| Fitbit Sense / Google Pixel Watch 3 | FDA-cleared | ECG, AFib detection |
| Omron HeartGuide | FDA-cleared | Clinically validated blood pressure monitoring |
| Withings ScanWatch | FDA-cleared | ECG, SpO2, AFib |
| AliveCor KardiaMobile / KardiaBand | FDA-cleared | Single-lead ECG |
| Biostrap Vital Signs Platform | FDA-cleared | ECG |
There are also a few devices under study, such as the Google Pixel Watch Blood Pressure Screening and Fitbit Labs experimental features.
What Consumer Smartwatches Offer
Most smartwatches stay in the wellness category in order to avoid FDA regulations. These smartwatches typically offer wellness-only features such as:
- HRV
- Sleep stage estimations
- Stress scores
- Readiness scores
- SpO2
- Activity zones
- VO2 max
These features are estimates based on your baseline and rely on the device’s algorithm. The placement of these sensors, light, skin tone, tattoos, temperature and movement also play a big role in these readings.
A high HRV score on a restless night does not require medical attention, but an FDA-cleared ECG report that shows signs of AFib absolutely does.
Accuracy: Are FDA-Cleared Devices Always Better?
This might come as a shock to you, but surprisingly, FDA-cleared devices are not always better.
Jaw-dropping, I know. So here’s the thing: why I say this is because while these FDA-cleared devices undergo rigorous testing, these readings are still limited by movement, the temperature of your skin, skin tone and tattoos.
While these devices will outperform regular devices in long-term trends, they are still subject to external factors that may affect these readings.
But for diagnosing arrhythmias, monitoring blood pressure or making any clinical decisions, FDA-cleared devices are the way to go!
Should You Upgrade to an FDA-Cleared Wearable?
So now that you have a full picture of the benefits and the limitations of an FDA-cleared device as opposed to a consumer smartwatch, should you upgrade?
Let me give you a few facts:
- 67% of the doctors see value in wearable data and recommend them for monitoring your symptoms.
- Remote Patient Monitoring (RPM) programs reduce hospital re-admissions by 38%.
- Wearables can help you cut down healthcare costs by up to 30%.
- Out of these, smartwatches dominate the wearable market with around half or more of the total market share.
The data divides the medical community: while wearable devices help countless people detect medical conditions they never knew they had, screening and obsessing over the data can lead to overdiagnosis of healthy people.
Consider Upgrading if:
- You have a heart condition.
- Have a medical family history.
- You are 50+ and want to monitor your health better.
- You are in an RPM program.
You May Not Need FDA-level Accuracy if:
- You want general health insights.
- You use wearables and smartwatches for fitness goals.
- You don’t have a health condition that requires continuous monitoring.
Wrap Up
Smartwatches have FDA-cleared metrics, smart rings are entering the clinic space, sweat sensors, metabolic monitors and AI-driven health prediction models are already in development. This suggests more and more wearables are moving towards seeking FDA approvals.
For now, stick with your smartwatches if you don’t have a medical condition to monitor, but definitely look into upgrading to an FDA-cleared device if you do. It will be an investment in your health that will be worth making.
