Apple Watch 4 Is Now An FDA Class 2 Medical Device: Detects Falls, Irregular Heart Rhythm

(Source: www.forbes.com)

Cleared by the Food and Drug Administration (FDA), the new Apple Watch Series 4 that was unveiled on Wednesday is turning into a serious medical device with fall detection and 3 new heart monitoring capabilities: low heart rate alert, heart rhythm detection, and a personal electrocardiogram (ECG) monitor.

“I was not in the market for a watch and actually I haven’t used one for more than 10 years,” confides Marco Graziano, CEO of Palo Alto startup Visible Energy. “But the ECG capability would be very useful for me to help track my overall heart condition because of my hypertension.”

Fall detection

According to Apple COO Jeff Williams, the leading causes of injuries worldwide are falls and “whether you slip off a stepladder or you trip on a curve, a hard fall can be serious and it can be difficult to get immediate help.”

The new Apple Watch can detect a fall thanks to a new accelerometer and gyroscope which measures up to 32 g-forces and can now analyze the wrist trajectory and impact acceleration to determine when a fall occurs.

“And after detecting a fall, series 4 delivers an alert and from that alert, you can initiate an emergency call,” said Williams. “However if the watch senses you are immobile for 1 minute, it will start the call automatically and it also sends a message with your locations to your emergency contacts using the SOS feature that is already built into Apple Watch.”

3 new heart monitoring capabilities

The built-in optical heart sensor, that was present since the launch of the first Apple Watch, currently allows to calculate the calorie burn during workouts, determine the resting heart rate and powers the high heart rate notification.

With its second-generation electrical heart sensor, the Apple Watch can now notify you if your heart rate appears to be too low – if it’s too low it

might mean that your heart isn’t pumping enough blood to the body and that could be a sign of something serious – and screen your heart

rhythm in the background for irregular rhythm that appears to be atrial fibrillation which can lead to serious complications (decreased blood pressure, light-headedness, weakness or shortness of breath) that needs to be monitored closely.

“It won’t catch every instance of afib but we believe this is going to help a lot of people who didn’t otherwise know they had an issue,” noted Williams.

The third heart monitor feature is the ECG and allows you to take an electrocardiogram anytime, anywhere, right from your wrist and in just 30 seconds. You just need to open the app and you put your finger on the digital crown and the watch will start detecting the electrical impulses from your heartbeat and at the completion of the ECG recording you will receive a heart rhythm classification: If your heart is beating in a normal rhythm the app will classify the measurement as sinus rhythm and the app will also classify atrial fibrillation.

“This is the first ECG product offered over-the-counter directly to consumers,” disclosed Williams. “I’m also pleased to say we’ve received clearance from the FDA.”

Atherton Research’s Take

Although the Apple Watch 4 had not received FDA approval – which involves a more rigorous review process for class 3 devices that usually sustain or support life or present potential unreasonable risk of illness or injury – the FDA “clearance” is already a great step towards Apple’s vision to make its watch the “guardian” of your health and we expect the watch to be a hot seller during the holiday season.

Some other FDA-cleared consumer ECG devices available include AliveCor’s KardiaBand and KardiaMobile that work with an Apple Watch or a smartphone/tablet (Android or iOS), respectively, and QuardioCore (only outside of the U.S.) which does continuous ECG monitoring.

More Info: www.forbes.com

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