The Central Drug Standard Control Organization (CDSCO), India’s regulatory authority under the Health Ministry of India, approved the wearable medical-grade smartwatch CardiacSense made by Israel’s Medtech company CardiacSense Ltd.
Medtech solutions provider Xplore Health, which has a presence in Pune, Mumbai, Delhi and Bangalore, also received approval from the CDSCO to commercialize this medical device in the Indian market in collaboration with the Israeli company.
CardiacSense technology ensures the continuous monitoring of a person’s vital signs. Whenever heart rates are increased or decreased, or there are arrhythmias, the watch prompts the user to take an ECG and share it instantly with the doctor for immediate advice. This feature will enable doctors and hospitals to monitor patients round the clock.
The product has already been approved by U.S. Food and Drug Administration and is the only medical watch to demonstrate accuracies higher than FDA’s thresholds, according to the company. CardiacSense is now available in over 40 countries, including the U.S. all European countries, Australia, New Zealand, and many other South American countries.
