The Fastest FDA-Approved Product on the Market

Each September, Apple announces new products in a live broadcast event. Last week during the announcement apple revealed its Apple Watch Series 4. You’re probably thinking, wow great, another smart watch with some new mundane features. Not so fast. The Series 4 Apple Watch boasts ECG features. Apple COO, Jeff Williams, explained at the event that Apple has received FDA clearance for both “an atrial fibrillation-detecting algorithm and an ECG that will be build into the new watch. “

During the announcement, Williams went on to say: "I’m also pleased to say we’ve received clearance from the FDA." Williams also stated, "This is a De Novo clearance, so it’s the first of its kind. The irregular heart rhythm alert has also received FDA clearance.

The watch will now screen your heart rhythm and will send you a notification if an irregular rhythm is detected. Williams explained, “it won’t catch every instance of a-fib, but this is going to help a lot of people who didn’t realize they had an issue.” In addition to screening heart rhythms the watch can alert users with low or high heart rates.

The ECG is by far the biggest feature on the new watch. In addition to the optical heat sensor, Apple designed an electrical heart sensor that will allow you take an electrocardiogram (or ECG), and allow you to share it with your doctor or nurse.

It will take about 30 seconds for the user to take an ECG. Once completed, the information is stored on Apple’s Health App. This will allow some users the ability to send the readings directly over to their doctors.

Another notable feature of the Series 4 watch is fall detection. During the announcement, Williams explained that, "[Apple] collected data on thousands of people and captured data on real-world falls and we learned something. ... When you trip, your body will naturally pitch forward and your arms will go forward to brace yourself. However, if you slip, there’s a natural upward motion in the arms. These are motions Series 4 is ideally suited to recognize. With a new accelerometer and gyroscope, the watch analyzes wrist trajectory and impact acceleration to determine when a fall occurs. And from that it issues an alert."

If the watch has detected a fall, it will give the watch user the opportunity to call for emergency help. However, if the user is immobile for one minute after a fall is detected, it will automatically call for emergency help.  If the user has provided emergency contact information, the watch will also send a message to those designated persons.

The Apple Health App holds a lot of your personal data, but is only a portion of the full picture. Extract’s HealthyData Platform ensures data from other valuable sources such as faxes or scans is captured accurately, and made quickly available for healthcare providers.

If you are interested in learning more please reach out today.

The watch is available on September 21.





About the Author: Taylor Genter

Taylor is the Marketing Specialist at Extract with experience in data analytics, graphic design, and both digital and social media marketing.  She earned her Bachelor of Business Administration degree in Marketing at the University of Wisconsin- Whitewater. Taylor enjoys analyzing people’s behaviors and attitudes to find out what motivates them, and then curating better ways to communicate with them.