Medical-grade Smartwatch CardiacSense receives approval from US-FDA & CDSCO India: Achieves major milestones ahead of launch in India

• CardiacSense Medical Watch receives approval from the Indian regulatory authority CDSCO

• CardiacSense also received US-FDA-approvals for its medical watch.

• CardiacSense is now selling in over 40+ countries across the globe including India

• In the coming few months, CardiacSense will be also able to show real-time Live ECGs to doctors.

• Currently patients can share ECG instantly with doctors and seek immediate advice.

• CardiacSense packs live Vital Signs Monitoring Features which are constantly recorded and can be viewed for further analysis by doctors or caregivers. This 24/7 Vitals monitoring and recording is very unique to CardiacSense Technology.

NEW DELHI: Leading and futuristic 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 aspirational 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 Watches. 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.

Citing the importance of knowing your heart health at the initial level, Mr. Pankaj Balwani, Founder & CEO of Xplore Health, said, “ As India and the world over, there has been a big surge in Cardiac related 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.

CardiacSense technology is designed to ensure that one is able to continuously monitor their Vital signs and whenever there is a notification raised by the watch for increased or decreased heart rates or for Arrhythmias, the watch prompts the user to take an ECG and shares it instantly with the doctor for immediate advice.

Timely advise by doctors can make a huge difference in getting the right and timely treatments and avoiding unnecessary hospitalization or delays which lead to life-threatening events.

CardiacSense is one such device that will enable doctors and hospitals to monitor patients 24/7 who have recently undergone major surgeries or those suffering from chronic heart disease or organ failure.

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. Especially for patients who have been discharged from the hospital, it’s very important to be able to monitor those patients and check improvements or deterioration of their health. CardiacSense advanced Vitals monitoring solution gives unique flexibility and convenience to doctors and caregivers 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.

CardiacSense Medical Watch also can help people who are at risk of suffering from STROKE. It’s a known fact that Atrial Fibrillation also called Afib ( A kind of Arrhythmia ), is responsible for increasing the risk of Ischemic Stroke by over 5 times.

CardiacSense is able to monitor Atrial Fibrillation ( AFib ) 24/7 creating a record of Afib load with time logs of the 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. 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.

One must understand the difference between a Medical Watch and a Fitness Tracker Watch. Fitness trackers are not designed for Medical Use, while MedTech product Solutions like CardiacSense which are beat-by-beat and breath-by-breath monitoring solutions are rigorously tested and approved by CE MDR in European Union, US-FDA, CDSCO, India, TGA, Australia and Medsafe, New Zealand. When it comes to patients with serious heart or other medical conditions, should rely only on medically approved products.