Medical watch CardiacSense gets approval from Indian regulatory authority CDSCO

The approval came ahead of its commercial launch in collaboration with Israeli Medtech company CardiacSense Ltd.

New Delhi: Homegrown MedTech solutions provider Xplore Health on Thursday announced that it received approval from the Indian Regulatory Authority CDSCO (Central Drug Standard Control Organization) under the Health Ministry of India for its aspirational medical smartwatch “CardiacSense”.

The approval came ahead of its commercial launch in collaboration with Israeli Medtech company CardiacSense Ltd.

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The product has already been approved by the US Food and Drug Administration (FDA) and is the only medical watch to demonstrate accuracies higher than FDA-set Thresholds, making it one of the only approved Medical Watch, according to the company.

“CardiacSense technology is designed to ensure that one is able to continuously monitor their Vital signs and whenever there is a notification raised by the watch for increased or decreased heart rates or for Arrhythmias, the watch prompts the user to take an ECG and shares it instantly with the doctor for immediate advise,” Pankaj Balwani, Founder & CEO of Xplore Health, said in a statement.

“CardiacSense is one such device that will enable doctors and hospitals to monitor patients 24/7 who have recently undergone major surgeries or those suffering from chronic heart disease or organ failure,” he added.

After receiving approval from India, CardiacSense is now available in over 40 countries, including the US, all European countries, Australia, New Zealand, and many other South American countries, said the company.