New Delhi: Homegrown Medical technology solution provider explore health announced on Thursday that it has received approval from the Indian Regulatory Authority CDSCO (Central Drug Standards Control Organization) under the Ministry of Health from India for his aspirational medical smart watch “cardiac sense“.
The approval came ahead of its commercial launch in collaboration with the Israeli company Medtech CardiacSense Ltd. The product has already been approved by the US Food and Drug Administration (FDA) and is the only medical watch to demonstrate accuracies above thresholds set by the FDA, making it one of the only approved medical watches, according to the company.
“CardiacSense technology is designed to ensure that one can continuously monitor their vital signs and whenever the watch issues a notification of increased or decreased heart rate or arrhythmias, the watch prompts the user to take an ECG and shares it instantly . with the doctor for immediate advice,” said Pankaj Balwani, founder and CEO of Xplore Health, in a statement.
“CardiacSense is one such device that will allow doctors and hospitals to monitor patients 24/7 who have recently had major surgeries or who have chronic heart disease or organ failure,” added.
After receiving approval from India, CardiacSense is now available in more than 40 countries, including the US, all European countries, Australia, New Zealand and many other South American countries, the company said.
