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FDA Approves Medtronic’s Remote Monitoring Pacemaker App

by Fred Pennic 11/18/2015 1 Comment

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FDA Approves Medtronic's Remote Monitoring Pacemaker AppThe U.S. Food and Drug Administration (FDA) has cleared approval and U.S. commercial availability of Medtronic’s MyCareLink Smart(TM) Monitor, an app-based remote monitoring system for patients with implantable pacemakers. The app-based system makes it easy for heart device patients to stay connected to their doctor.

How It Works

Prescribed by a physician, The MyCareLink Smart Monitor is comprised of a handheld portable device reader and the MyCareLink Smart mobile app, available for free on both Android(TM) and Apple® platforms. When the MyCareLink Smart Monitor is connected to cellular or Wi-Fi service, patient data is securely transmitted from their pacemakers to their physicians between clinic visits or whenever a patient is not feeling well. The physician can then interpret the data to make treatment decisions.

In addition to sending information from their pacemakers to their physicians or clinics, patients using the MyCareLink Smart Monitor can:

– Confirm the date of their most recent transmission of pacemaker information

– Create a personalized profile on the MyCareLink Connect Website to manage their pacemaker information and data transmissions

– Receive email or text reminders, confirmations and notifications of their data transmissions

By connecting patients and physicians, remote cardiac monitoring provides many clinical and economic benefits. These include:

– faster time to treatment if the physician detects a problem with the pacemaker based on the transmitted data

– less time spent at a doctor’s office or clinic for regular checks of the pacemaker

– reduced time spent in the hospital if the physician quickly detects and treats a medical problem

– potential increase in patient survival rates

“Remote monitoring of pacemakers and other cardiac devices is now the standard of care, as studies have established how it benefits patients – including faster diagnoses and increased survival – as well as how it helps physicians manage their pacemaker patients through increased efficiency and convenience,” said George Crossley, III, M.D., associate professor of medicine and electrophysiologist at Vanderbilt Heart and Vascular Institution in Nashville, Tennessee in on official statement.

“Because the MyCareLink Smart Monitor is integrated into existing mobile platforms like smartphones and tablets, it is easy for patients to transmit data from their pacemakers to their doctors via the technology that they are using every day. This innovation will serve as the foundation for future advances using smart technology to support cardiac patients.”

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Tagged With: Cardiac Devices, Medtronic, Pacemakers

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