China Approves EKG Glove from iNeedMD

New York, N.Y.-based iNeedMD Holdings Inc., a medical device development company, has received its China Food and Drug Administration (CFDA) registration certificate for the EKG (electrocardiogram) Glove.

The CFDA is the main administrative authority charged with the regulation and control of medical devices in China. With CFDA approval, iNeedMD can solidify relationships with local Chinese distribution and sales organizations to promote The EKG Glove, especially in the rapidly emerging telemedicine market.

The company reports that China’s primary care system is underfunded with basic medical services often absent outside of highly taxed public hospitals located in Tier 1 cities such as Beijing or Shanghai. As a result, telemedicine may offer China an opportunity to create an easily accessible point-of-care healthcare system in the other Tier 2 through Tier 7 cities that make up 98 percent of China’s aggregate population.

According to the World Health Organization (WHO), cardiovascular disease impacts approximately 230 million Chinese citizens, which equates to one-in-five Chinese adults. In addition, the WHO estimates that between 2010 and 2030, annual cardiovascular events are projected to “increase by 50 percent based on population aging and growth alone.” As a result, iNeedMD expects that the widespread availability of diagnostic 12-lead EKGs, the mainstay of universal cardiac care, will be integral to the diagnosis or rule-out of cardiac events or conditions in any comprehensive telemedicine system.

EKGs assess the electrical activity of an individual’s heart and traditionally require a trained professional to place a complicated system of 10 electrodes and 10 corresponding lead wires in a specific configuration on an individual’s chest to obtain an EKG tracing. The EKG Glove integrates a standardized system of electrodes and lead wire circuitry into a one-piece, disposable glove-like sheath that can be easily positioned on an individual’s chest to acquire a diagnostic, 12-lead EKG. Its peel-and-stick format can be deployed in less than 60 seconds with minimal instruction making it appropriate for use in clinic, pre-hospital, and remote testing environments where access to highly-skilled technicians may be a challenge, the company claims. A single cable connects The EKG Glove to a variety of portable Bluetooth-enabled EKG acquisition devices or more stationary EKG machines.

“The company has been tracking the various guidance documents issued by the National Health and Family Planning Commission of the People’s Republic of China (NHFPC),” said iNeedMD’s President and CEO Thomas Nicolette. “In early 2015, the NHFPC outlined a plan to build a uniform national telemedicine service network throughout the country’s vast geography given the shortage of primary care providers and facilities. We believe remote electrocardiograms are built into the framework of China’s evolving healthcare system. As a result of the CFDA’s approval of The EKG Glove and the device’s ability to be paired with a variety of portable EKG acquisition devices, iNeedMD is now able to begin forging partnerships with well-established distributors within the Chinese medical device market. We anticipate further announcements as to these agreements within the fourth quarter of this year.”

iNeedMD Holdingsmakes medical device solutions for the acquisition, storage and export of health- and wellness-related data in convenient, portable platforms.