We are filing 510K US FDA notification in association with our US FDA counterpart FDASmart http://www.fdasmart.com/
Expected date for obtaining US FDA is end of 2017
We will keep you posted on this more more updates.
Agatsa manufactures easy-to-use, connected medical device SanketLife which is capable to take medical grade/ diagnostic 12-Lead ECG and share the report to doctors/ family/friends via smartphone. The device acquires medical data (like 12-Lead ECG) through sensors and send it to a smartphone for displaying and to the cloud for processing. The results are processed and displayed in readable format so that the report/results can be shared/reviewed and actioned in timely manner. Along with this SanketLife app provides an accurate Heart Rate, HRV, and other ECG parameters like PR, QTc R-R intervals etc.
Agatsa offers its users to purchase the device at a very small price and a monthly subscription package as per his usage needs to pay as per their usage.
Anybody can use it at his home, generate a report, share it to our doctor platform for review and quick advise/online consultation.
The device serves/ helpful for people who may be at risk of heart disease because there is a family history of heart disease, or because they smoke, are overweight, or have diabetes, high cholesterol or high blood pressure.
Also, the physicians can use to quickly screen their patients for any possible heart problem.Cardiologists use it to monitor and track their patients remotely and provide remote/home healthcare Very useful device for remote/rural monitoring
It gives a very accurate Heart rate and heart rate variability which gives an accurate picture of how healthy is one's heart; the ultimate indicator on one's Fitness.