Is Apple Watch medically approved?

Asked by: Prof. Aniyah Swift IV  |  Last update: April 28, 2025
Score: 4.5/5 (2 votes)

The FDA approves Apple Watch's heart monitoring tool for use in clinical trials. The Agency has qualified Apple's atrial fibrillation history feature as a medical device development tool, allowing it to be used in clinical trials.

Can Apple Watch be used as a medical device?

Apple Watch checks for unusually high or low heart rates in the background, which could be signs of a serious underlying condition. This could help you and your patients identify situations that may warrant further evaluation.

Can Apple Watch be used as a medical alert?

After the call ends, your watch sends a message to your emergency contacts with your location letting them know that your watch detected a hard fall and dialed emergency services. Your watch gets your emergency contacts from your Medical ID. You can't set emergency services as an emergency contact.

Is an Apple Watch a qualified medical expense?

While your Apple Watch, Garmin, or other tracker may offer you some insight—and maybe even some encouragement—to stay on top of your fitness routine, they are not typically considered medical devices for purposes of FSA and HSA funds.

Do cardiologists recommend Apple watches?

It allows them to understand lifestyle choices may impact their health. And from my perspective, it allows me to monitor my patients long term, remotely, no matter where they are in the world, to understand what's going on with their heart rhythm, simply by doing an EKG from the watch itself," Passman told CBS News.

The Apple Watch ECG found something unexpected about my heart

15 related questions found

Is Apple Watch ECG medically approved?

Modern mobile ECG recording devices that can monitor patients' heart activities around the clock have made this a reality. The Apple Watch is one of these portable ECG devices that can detect heart rhythms and is approved by the American FDA for screening and detecting AF.

Can a doctor prescribe an Apple Watch?

That would require regulatory approval from the Food and Drug Administration, not to mention a prescription from your doctor to get one. The Apple Watch, therefore, is positioned as a handy way to oversee various aspects of daily activities, but not as a way to treat medical conditions.

Is Apple Watch medically certified?

The Apple Watch is the first-ever digital health technology to qualify for the program, which means it can be used in clinical trials, for a start. According to My Healthy Apple, the qualification means that the Watch is recognized “to provide a non-invasive way to check estimates of AFib burden.”

Can nurses claim Apple Watch on tax?

Be warned, Apple watches or similar are considered “ordinary timepieces” and can't be claimed. Also, if your special nursey fob watch cost more than $300, then you can't claim the whole cost, just the “depreciation.” If you don't know what that means, check with your accountant.

Why is Apple discontinuing the Apple Watch?

Apple pulls online sales of Apple Watches

Both watches will disappear from Apple's brick-and-mortar stores after December 24th. The ban is the result of a patent dispute with medical device maker Masimo. The ITC has ruled that the SpO2 sensor in Apple's smartwatches infringes upon Masimo's patents.

Are Apple watches medically accurate?

In our study, it was shown that in patients with cardiovascular disease, the Apple Watch measures HR during exercise with clinically acceptable accuracy: there was no systematic error and bias was small compared to ranges of HR recommended in rehabilitation programs.

Will the Apple Watch call 911 if your heart stops?

: Even though Apple Watch can send alerts for irregular heart rhythms, it won't initiate an emergency call on its own if your heart stops or slows to dangerous levels.

Is the Apple Smart watch FDA approved?

Apple has received FDA approval for the sleep apnea detection feature on the newest version of the software for its smartwatches.

Is Apple Watch a good medical alert system?

Bottom Line. The Apple Watch has top-notch software and hardware, but it isn't designed to be a medical alert device. It's an option for tech-savvy users who are familiar with the Apple ecosystem. The $499 hardware cost for the Series 9 GPS + Cellular device is high compared to other systems.

Can surgeons wear Apple Watch?

Traditional monitoring methods, like using Holter electrocardiogram monitors, are impractical in the operating room, limiting the assessment of physicians' health. Wrist-worn heart rate monitors, like the Apple Watch, offer promise but are restricted in surgeries due to sterility issues.

Is the Apple Watch registered as a medical device?

The FDA certified Apple Watch is still not a medical device.

Can Apple Watch detect illness?

The Vitals app establishes a typical range for each of your health metrics collected as you sleep. If multiple metrics are outside your typical range, you receive a notification along with context for factors that may be involved—like medications, elevation changes, or illness, for example.

What is the FDA approved smart watch for blood pressure?

Omron HeartGuide – Best watch overall

Omron HeartGuide is the first FDA-approved watch that can monitor blood pressure. It can track your sleep patterns and fitness data like calories burned and steps taken. Its FDA clearance means you can be sure of clinically accurate blood pressure measurements.

Do cardiologists recommend Apple Watch?

If you have an abnormal heart rhythm, over time your risk of stroke may increase. If you experience palpitations or fluttering, your doctor might recommend you use the Apple Watch or another wearable to track your heart.

Do doctors recommend smart watches?

Dr Alcock believes smart watches help motivate people to be more active. "Every day use for the general public, they're great … I think it's getting people exercising simply by having the watch."

Can an Apple Watch be a medical expense?

“The new Apple Watch Series 4 was approved by the FDA as an electrocardiogram or ECG. Does this mean someone can purchase the new Apple Watch and those funds count as a medical expense?” The answer is no.

How accurate is the Apple Watch ECG?

Previous studies assessed the ability of the Apple Watch to identify AF and found that it has a sensitivity of 98% versus standard 12-lead ECG [3]. The positive predictive value (PPV) of Apple Watch notifications was 84% [8]. The fact that the ECG on the smartwatch was of such great quality was also fascinating.

Can an Apple Watch measure blood pressure?

Gurman suggests the Apple Watch Series 11 and Watch Ultra 3 will not actually be used to spit out diastolic and systolic readings, as a $30 cuff solution from Amazon can, but will instead notify you when it looks as though your blood pressure is elevated.

Which Apple Watch is best for heart patients?

Apple Watch Series 4 and later and all models of Apple Watch Ultra also have built-in electrodes in the Digital Crown and the back of Apple Watch, which can measure the electrical signals across your heart when used with the Heart Rate app or the ECG app.