MedTech solutions provider Xplore Health on Thursday announced that it has received approval from the Indian Regulatory Authority Central Drug Standard Control Organization (CDSCO) 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 Ltd.
“The product has already been approved by USA’s FDA and is the only medical watch to demonstrate accuracies higher than FDA set Thresholds, making it one of the only approved Medical Watch. With its approval from CDSCO, the CardiacSense will be available in the Indian markets as well,” the company announced on Thursday.
The Indian regulatory authorities have given a green signal for its sale in India by issuing a registration certificate and license for its sales, it said.
“As India and the world over, there has been a big surge in Cardiac relaed deaths, and most deaths are attributed to people not being able to understand the early warning signs. Most people ignore these signs and move on with their lives taking those signs as normal discomforts. There is no life threatening cardiac event that happens suddenly. Our body starts to give early signals. One should be aware and watchful,” Pankaj Balwani, Founder & CEO of Xplore Health, said in a statement.
According to the company, 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.
Timely advise by doctors can make huge difference in getting the right and timely treatments and avoid unneccesary hospitalisation or delays which lead to life threatening events, it said.
CardiacSense is one such device that will enable doctors and hospials to monitor patients 24/7 who have recently undergone major surgeries or those suffering from chronic heart disease or organ failure, the company claimed.
“CardiacSense medical watch, comprises the very advanced features of Live ECG and advanced Vitals SIgns monitoring solutions that will make patient monitoring for doctors and hospitals very effective. Specially patients who have been discharged from hospital, its very important to be able to monitor those patients and check improvements or detrioration of their health. CardiacSense advanced Vitals monioring solution gives unique flexibility and convenienece to doctors and care givers to monitor their patients. The most prominent feature of this medical watch is its capability to conduct Live ECG even remotely, which is being launched in India soon, it added.
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. Xplore Health in collaboration with CardiacSense is ensuring that CardiacSense Medical Watch is available for everyone and is making the device available for sale on easy EMI and through various other schemes so that patients from all walks of life can benefit by using this MEdical Watch, it stated.
