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The new Apple Watch Series 4 is now an FDA-approved Class 2 medical device that can detect falls and add advanced cardiac monitoring features. (Photo by NOAH BERGER / AFP / Getty Images)
Unveiled by the Food and Drug Administration (FDA), the new Apple Watch Series 4, unveiled Wednesday, turns into a serious medical device with fall detection and 3 new cardiac monitoring capabilities: low heart warning, heart rate detection and monitor electrocardiogram (ECG) staff.
"I was not in the market for a watch, and in fact I have not used it for more than 10 years," says Marco Graziano, CEO of start-up Palo Alto Visible Energy. "But the ability of the ECG would be very helpful in helping to track my overall heart condition because of my high blood pressure."
Fall detection
According to Apple's chief operating officer, Jeff Williams, the leading causes of injury in the world are falls and "whether you fall off a stepladder or you fall on a curve, a fall brutal can be serious and get immediate help. "
The new Apple Watch can detect a fall thanks to a new accelerometer and a gyroscope that measures up to 32 g forces and can now analyze the wrist trajectory and the acceleration of impact to determine the when a fall occurs.
"And after detecting a fall, Series 4 issues an alert and from this alert, you can initiate an emergency call," Williams said. "However, if the watch detects that you are still for 1 minute, the call starts automatically and also sends a message with your locations to your emergency contacts using the SOS feature already built into Apple Watch."
3 new cardiac monitoring capabilities
The integrated optical heart rate sensor, which has been around since the launch of the first Apple Watch, currently calculates calorie consumption during workouts, determines resting heart rate, and enables high heart rate reporting. .
Thanks to its second-generation electric heart sensor, the Apple Watch can now inform you if your heart rate seems too low – if it's too weak
It could mean that your heart does not pump enough blood for the body and that this could be a sign of something serious – and filter your heart
rhythm in the background for an irregular rhythm that appears to be atrial fibrillation that can lead to serious complications (low blood pressure, lightheadedness, weakness or shortness of breath) that need to be closely monitored.
"He's not going to catch every instance of afib, but we think that will help a lot of people who did not know otherwise that they had a problem," Williams noted.
The third function of the heart monitor is the ECG and allows you to take an electrocardiogram anytime, anywhere, directly from your wrist and in just 30 seconds. Just open the app and put your finger on the digital crown. The watch will detect the electrical impulses of your heart rate and at the end of the ECG recording you will receive a heart rate classification: if your heart beats a normal rhythm the app will rank the measurement as sinus rhythm and the application will also classify atrial fibrillation.
"This is the first nonprescription ECG product available directly to consumers," Williams said. "I am also happy to say that we have received clearance from the FDA."
Atherton Research & # 39; s Take
Although the Apple Watch 4 has not received FDA approval – this involves a more rigorous review process for Class 3 devices that generally maintain or support life. or present a potential risk of illness or injury – the FDA's "clearance" is already a big step forward in making his watch the "guardian" of your health and we expect the watch to be a seller hot during the holidays.
Other FDA-approved consumer ECG devices include AliveCor's KardiaBand and KardiaMobile, which operate with an Apple Watch or smartphone / tablet (Android or iOS) respectively, and QuardioCore (outside the US only). ).
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The new Apple Watch Series 4 is now an FDA-approved Class 2 medical device that can detect falls and add advanced cardiac monitoring features. (Photo by NOAH BERGER / AFP / Getty Images)
Unveiled by the Food and Drug Administration (FDA), the new Apple Watch Series 4, unveiled Wednesday, turns into a serious medical device with fall detection and 3 new cardiac monitoring capabilities: low heart warning, heart rate detection and monitor electrocardiogram (ECG) staff.
"I was not in the market for a watch, and in fact I have not used it for more than 10 years," says Marco Graziano, CEO of start-up Palo Alto Visible Energy. "But the ability of the ECG would be very helpful in helping to track my overall heart condition because of my high blood pressure."
Fall detection
According to Apple's chief operating officer, Jeff Williams, the leading causes of injury in the world are falls and "whether you fall off a stepladder or you fall on a curve, a fall brutal can be serious and get immediate help. "
The new Apple Watch can detect a fall thanks to a new accelerometer and a gyroscope that measures up to 32 g forces and can now analyze the wrist trajectory and the acceleration of impact to determine the when a fall occurs.
"And after detecting a fall, Series 4 issues an alert and from this alert, you can initiate an emergency call," Williams said. "However, if the watch detects that you are still for 1 minute, the call starts automatically and also sends a message with your locations to your emergency contacts using the SOS feature already built into Apple Watch."
3 new cardiac monitoring capabilities
The integrated optical heart rate sensor, which has been around since the launch of the first Apple Watch, currently calculates calorie consumption during workouts, determines resting heart rate, and enables high heart rate reporting. .
Thanks to its second-generation electric heart sensor, the Apple Watch can now inform you if your heart rate seems too low – if it's too weak
It could mean that your heart does not pump enough blood for the body and that this could be a sign of something serious – and filter your heart
rhythm in the background for an irregular rhythm that appears to be atrial fibrillation that can lead to serious complications (low blood pressure, lightheadedness, weakness or shortness of breath) that need to be closely monitored.
"He's not going to catch every instance of afib, but we think that will help a lot of people who did not know otherwise that they had a problem," Williams noted.
The third function of the heart monitor is the ECG and allows you to take an electrocardiogram anytime, anywhere, directly from your wrist and in just 30 seconds. Just open the app and put your finger on the digital crown. The watch will detect the electrical impulses of your heart rate and at the end of the ECG recording you will receive a heart rate classification: if your heart beats a normal rhythm the app will rank the measurement as sinus rhythm and the application will also classify atrial fibrillation.
"This is the first nonprescription ECG product available directly to consumers," Williams said. "I am also happy to say that we have received clearance from the FDA."
Atherton Research & # 39; s Take
Although the Apple Watch 4 has not received FDA approval – this involves a more rigorous review process for Class 3 devices that generally maintain or support life. or present a potential risk of illness or injury – the FDA's "clearance" is already a big step forward in making his watch the "guardian" of your health and we expect the watch to be a seller hot during the holidays.
Other FDA-approved consumer ECG devices include AliveCor's KardiaBand and KardiaMobile, which operate with an Apple Watch or smartphone / tablet (Android or iOS) respectively, and QuardioCore (outside the US only). ).
