Last Updated on December 31, 2023 by The Health Master
The Indian Regulatory Authority, the Central Drug Standard Control Organization (CDSCO), which is part of the Health Ministry of India, has given the go-ahead for Xplore Health, a provider of medtech solutions, to market 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
The product has already been approved by USFDA. The CardiacSense will be accessible in Indian markets as well after receiving CDSCO approval.
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 intended to ensure that one’s vital signs are continuously monitored, and whenever the watch raises a notification for increased or decreased heart rates or arrhythmias, the watch prompts the user to take an ECG and immediately share it with the doctor for immediate advice.
It will enable doctors and hospitals to monitor patients 24/7.
It has features like live ECG monitoring and sophisticated vital sign monitoring systems, which will make patient monitoring for doctors and hospitals very efficient.
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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