CardiacSense Medical Watch, capable of sharing ECG in real-time, gets approval from regulator
After this approval, the watch will be available in the Indian markets as well.
MedTech solutions provider Xplore Health has received approval from the Indian Regulatory Authority CDSCO (Central Drug Standard Control Organization) for its aspirational medical watch CardiacSense. The watch has already got approval from the USA’s Food and Drug Administration (FDA) and is the only device to demonstrate accuracies higher than the FDA's set thresholds, making it one of the only approved medical watches.
After this approval, the watch will be available in the Indian markets as well. The Indian regulatory authorities have given a green signal for its sale in India by issuing a registration certificate and license for its sales.
Emphasising the importance of knowing your heart health at an early stage, Pankaj Balwani, founder & CEO of Xplore Health, said that CardiacSense technology is designed to ensure that one is able to continuously monitor their vital sign.
“As India and the world over, there has been a big surge in Cardiac related deaths, and most deaths are attributed to people not being able to understand the early warning signs. Most people ignore these signs and move on with their lives taking those signs as normal discomforts. There is no life-threatening cardiac event that happens suddenly. Our body starts to give early signals. One should be aware and watchful,"
CardiacSense sends a notification when there are increased or decreased heart rates or Arrhythmias. This prompts the user to take an ECG and share it instantly with the doctor for immediate advice.
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Timely advice by doctors can make a huge difference in getting the right and timely treatments and avoiding unnecessary hospitalisation or delays which lead to life-threatening events.
CardiacSense can enable doctors and hospitals to monitor the health of patients who have recently undergone major surgeries or those suffering from chronic heart disease or organ failure 24/7.
CardiacSense Medical Watch also can help people who are at risk of suffering from STROKE. It's a known fact that Atrial Fibrillation also called as Afib ( A kind of Arrhythmia ), is responsible for increasing the risk of Ischemic Stroke by over 5 times.
CardiacSense is able to monitor Atrial Fibrillation ( AFib ) 24/7 creating a record of Afib load with time logs of the start and end of Afib events while patients wear the watch. This helps doctors identify the risks to these patients and advise on treatments accordingly.
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