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MDA approves ECG app on Apple Watch in Malaysia
The ECG app and the irregular rhythm notification feature received regulatory approval from the MDA in Malaysia as Class B software medical devices. - Photo courtesy of Apple
KUALA LUMPUR: The Ministry of Health's Medical Device Authority (MDA) has given regulatory approval for the ECG app and the irregular rhythm notification feature on the Apple Watch to be able to be used in Malaysia.
MDA has classified the Apple Watch as a Class B software medical device.
The ECG app on Apple Watch Series 4, 5, and 6 is now available in Malaysia with iOS 14.6 and watchOS 7.5.
MDA has classified the Apple Watch as a Class B software medical device.
The ECG app on Apple Watch Series 4, 5, and 6 is now available in Malaysia with iOS 14.6 and watchOS 7.5.
Consistent Across Nations
Prior to receiving the MDA approval in Malaysia, the Apple Watch's ECG app is already made available in a host of countries including the United States and Singapore.
Apple first introduced the ECG app on the Apple Watch in their September 2018 Keynote address, with the US as the first country that has given regulatory approval for usage in the general public.
Since then, over twenty nations have given its approval for use.
Prior to receiving the MDA approval in Malaysia, the Apple Watch's ECG app is already made available in a host of countries including the United States and Singapore.
Apple first introduced the ECG app on the Apple Watch in their September 2018 Keynote address, with the US as the first country that has given regulatory approval for usage in the general public.
Since then, over twenty nations have given its approval for use.
First DTC To Take ECG
The feature marks the first direct-to-consumer product that enables users to take an electrocardiogram right from their wrist, capturing heart rhythm the moment they want to know more about their heart health and share this critical information with their doctors.
The irregular rhythm notification feature on Apple Watch Series 3 and later will also occasionally check heart rhythms in the background and send a notification if an irregular heart rhythm that appears to be atrial fibrillation (AFib) is identified.
The feature marks the first direct-to-consumer product that enables users to take an electrocardiogram right from their wrist, capturing heart rhythm the moment they want to know more about their heart health and share this critical information with their doctors.
The irregular rhythm notification feature on Apple Watch Series 3 and later will also occasionally check heart rhythms in the background and send a notification if an irregular heart rhythm that appears to be atrial fibrillation (AFib) is identified.
ECG App
Electrodes built into the back crystal and Digital Crown on Apple Watch Series 4, 5, and 6 work together with the ECG app to enable users to take an ECG similar to a single-lead reading.
To take an ECG recording at any time, users launch the ECG app on Apple Watch Series 4, 5, and 6, and hold their finger on the Digital Crown.
As the user touches the Digital Crown, the circuit is completed, and electrical signals across their heart are measured.
After 30 seconds, the heart rhythm is classified as either AFib, AFib with high heart rate, sinus rhythm, low or high heart rate, inconclusive, or poor recording.
All recordings, their associated classifications, and any noted symptoms are stored securely in the Health app on iPhone. Users can share a PDF of the results with physicians.
Electrodes built into the back crystal and Digital Crown on Apple Watch Series 4, 5, and 6 work together with the ECG app to enable users to take an ECG similar to a single-lead reading.
To take an ECG recording at any time, users launch the ECG app on Apple Watch Series 4, 5, and 6, and hold their finger on the Digital Crown.
As the user touches the Digital Crown, the circuit is completed, and electrical signals across their heart are measured.
After 30 seconds, the heart rhythm is classified as either AFib, AFib with high heart rate, sinus rhythm, low or high heart rate, inconclusive, or poor recording.
All recordings, their associated classifications, and any noted symptoms are stored securely in the Health app on iPhone. Users can share a PDF of the results with physicians.
Irregular Rhythm Notification
Using the optical heart sensor in Apple Watch Series 3 and later, the irregular rhythm notification feature will occasionally check the user’s heart rhythm in the background for signs of AFib.
This would alert the user with a notification if an irregular rhythm is detected on five rhythm checks over a minimum of 65 minutes.
“The ECG app on Apple Watch will certainly bring a new dimension to patient care as a very accessible initial indicator of heart health,” said Dr. Mohamed Ezani Taib, cardiothoracic surgeon at the National Heart Institute (IJN) in Kuala Lumpur.
“AFib cases account for approximately one-third of our 200,000 cases annually here at the National Heart Institute, of which 40 percent are undiagnosed. Therefore, having an early warning system will be of immense benefit that will enable healthcare providers to better diagnose and treat heart rhythm issues earlier and potentially reduce the risk of complications, such as stroke, in the longer term,” added Dr. Ezani.
Using the optical heart sensor in Apple Watch Series 3 and later, the irregular rhythm notification feature will occasionally check the user’s heart rhythm in the background for signs of AFib.
This would alert the user with a notification if an irregular rhythm is detected on five rhythm checks over a minimum of 65 minutes.
“The ECG app on Apple Watch will certainly bring a new dimension to patient care as a very accessible initial indicator of heart health,” said Dr. Mohamed Ezani Taib, cardiothoracic surgeon at the National Heart Institute (IJN) in Kuala Lumpur.
“AFib cases account for approximately one-third of our 200,000 cases annually here at the National Heart Institute, of which 40 percent are undiagnosed. Therefore, having an early warning system will be of immense benefit that will enable healthcare providers to better diagnose and treat heart rhythm issues earlier and potentially reduce the risk of complications, such as stroke, in the longer term,” added Dr. Ezani.
Clinically Tested
The ability of the ECG app to accurately classify an ECG recording as AFib or sinus rhythm was validated in a clinical trial of around 600 participants.
Rhythm classification from a standard 12-lead ECG by a cardiologist was compared to the rhythm classification of a simultaneously collected recording from the ECG app.
The study found the ECG app on Apple Watch demonstrated 99.3 percent specificity in classifying sinus rhythm and 98.5 percent sensitivity in classifying AFib for the classifiable recordings.
In the study, 87.8 percent of recordings could be classified by the ECG app.
The irregular rhythm notification feature was studied in the Apple Heart Study. With over 400,000 participants, the Apple Heart Study was the largest screening study on atrial fibrillation ever conducted, also making it one of the largest cardiovascular trials to date.
The ability of the ECG app to accurately classify an ECG recording as AFib or sinus rhythm was validated in a clinical trial of around 600 participants.
Rhythm classification from a standard 12-lead ECG by a cardiologist was compared to the rhythm classification of a simultaneously collected recording from the ECG app.
The study found the ECG app on Apple Watch demonstrated 99.3 percent specificity in classifying sinus rhythm and 98.5 percent sensitivity in classifying AFib for the classifiable recordings.
In the study, 87.8 percent of recordings could be classified by the ECG app.
The irregular rhythm notification feature was studied in the Apple Heart Study. With over 400,000 participants, the Apple Heart Study was the largest screening study on atrial fibrillation ever conducted, also making it one of the largest cardiovascular trials to date.
How To?
To enable these new heart features, customers proceed through an onscreen setup.
This includes details about who can use these features, what the features can and cannot do, what results users may get, how to interpret those results.
It would also provide instructions for what to do if users are feeling symptoms that require immediate medical attention.
To enable these new heart features, customers proceed through an onscreen setup.
This includes details about who can use these features, what the features can and cannot do, what results users may get, how to interpret those results.
It would also provide instructions for what to do if users are feeling symptoms that require immediate medical attention.
#MDA
#Medical Device Authority
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#electrocardiogram
#AFib
#Atrial
#IJN
#heart
#medical device
#software
#Apple
#iPhone
#Singapore
#United States
#Kuala Lumpur
#health
#study
#Malaysia