CDSCO India and US FDA Approved Medical-Grade Smartwatch CardiacSense


The Indian regulatory body that falls under the Health Ministry of India, the Central Drug Standard Control Organization (CDSCO), has granted approval to the medical watch from Xplore Health called CardiacSense. The company said in a press release that CardiacSense is the only medical watch that has accuracy that is higher than the thresholds set by the FDA, making it one of the only approved medical watches.

CardiacSense will be available on the Indian market once CDSCO grants it approval, but the approval comes before the product’s commercial launch in collaboration with Israeli medical technology company CardiacSense Ltd. Pankaj Balwani, the founder and chief executive officer of Xplore Health, emphasized the significance of early cardiac health assessment in light of the rising number of heart disease-related deaths in India and around the world.

CardiacSense is designed to continuously monitor vital signs, according to Pankaj Balwani. The watch prompts the wearer to take an electrocardiogram (ECG) and immediately send it to a doctor for immediate guidance whenever a notification is raised for arrhythmias or increased or decreased heart rates.

READ  CVS to Acquire Signify Health in $8-Billion Deal

With prompt advice from doctors, getting the right treatments at the right time and avoiding unnecessary hospitalization or delays that can lead to life-threatening events can be greatly improved. The CardiacSense is one such device, and it will enable hospitals and doctors to continuously monitor patients with chronic heart disease, organ failure, or recent major surgeries.

The company asserts that hospitals and physicians can effectively monitor patients, particularly those who have been discharged from the hospital, thanks to the advanced vital signs monitoring solutions provided by CardiacSense. The medical watch’s ability to perform live ECGs even from a distance is its most notable feature. India will soon have access to it.

CardiacSense is now available in over forty countries, with approval from India, according to the release. The United States, all European nations, Australia, New Zealand, and numerous South American nations are included in this group. The CardiacSense Medical Watch is also available for purchase through a variety of other programs and simple EMI options to make it accessible to all.

READ  Cipla, Strides Pharma, and Glenmark Recall Products in the US