The product has already been approved by USFD
Medtech solutions provider Xplore Health receives approval from the Indian Regulatory Authority CDSCO (Central Drug Standard Control Organization) under the Health Ministry of India for its medical watch CardiacSense. The approval came ahead of its commercial launch in collaboration with Israeli Medtech company CardiacSense.
The product has already been approved by USFDA. With its approval from CDSCO, the CardiacSense 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.
CardiacSense technology is designed to ensure that one is able to continuosly monitor their vital signs and whenever there is a notification raised by watch for increased or decresed heart rates or for Arrhythmias, watch prompts the user to take an ECG and share it instanly with the doctor for immediate advise. It will enable doctors and hospitals to monitor patients 24/7.
It comprises of features like live ECG and advanced vitals signs monitoring solutions that will make patient monitoring for doctors and hospitals very effective. It can also monitor Atrial Fibrillation (AFib) 24/7 creating a record of Afib load with time logs of 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.
Having received approval from India, CardiacSense is now available in over 40 countries, including the USA, all European countries, Australia, New Zealand, and many other South American countries.
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