INDIA – MedTech solutions provider Xplore Health has received authorization from the Indian Regulatory Authority Central Drug Standard Control Organization (CDSCO) to market its wearable cardiac device in India.
Following the licensing agreement, Xplore Health is set to commercially launch its medical watch in collaboration with Israeli MedTech company CardiacSense Ltd.
The company is the distributor of the medical smartwatch product of Israeli medical device developer CardiacSense.
The wearable device has been approved by the US Food and Drug Administration (FDA) for medical use allowing device owners to remotely monitor unusually high or low heart rates and irregular heart rhythms.
In an official statement, Xplore Health said: “The product is the only medical watch to demonstrate accuracies higher than FDA set thresholds, making it the only approved Medical Watch.”
The MedTech solutions provider announced that the CardiacSense Medical Watch will be available in the Indian markets for continuous long-term vital signs monitoring.
India joins the United State, all European countries, Australia, New Zealand, and multiple South American countries in the list of Xplore Health’s product markets in the world.
With its approval from CDSCO, device owners and suppliers in India will be able to verify if their smartwatches are genuine or counterfeit at a time when unauthentic certificates flood the medical devices market.
CardiacSense technology allows device owners to continuously record their vital signals and to share the data with their doctors for medical assistance.
The wearable device will prompt the user to collect electrocardiogram (ECG) measurements and to share the data instantly with the doctor for immediate advice.
Without the use of the CardiacSense Medical Watch, patients can receive appropriate, timely treatment while avoiding unnecessary hospitalisation or delays which often lead to life-threatening events.
“CardiacSense is a wearable device that will enable doctors and hospitals to monitor patients who have recently undergone major surgeries or those suffering from chronic heart disease or organ failure,” the digital healthcare company claimed.
Countries around the world are experiencing a big surge in cardiovascular disease-related deaths, with most deaths attributed to people not being able to understand the early warning signs.
“There is no life-threatening cardiac event that happens suddenly. Our body starts to give early signals. One should be aware and watchful,” said Pankaj Balwani, Founder and Chief Executive Officer (CEO) of Xplore Health.
He pointed out that the CardiacSense watch features Live ECG and advanced vital signs monitoring solutions that will enable doctors and patients to effectively monitor patient’s cardiac health.
“Xplore Health in collaboration with CardiacSense is ensuring that the CardiacSense Medical Watch is available for everyone,” added CEO Balwani.
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