FDA Approves World’s First App-Based Remote Monitoring System for Pacemakers

Medtronic plc has gained U.S. FDA approval for the world’s first app-based remote monitoring system for patients with implantable pacemakers.


Medtronic will be making its MyCareLink Smart(TM) Monitor available right away following news of its approval.  The system means patients with a Medtronic pacemaker can use their own smartphone or tablet technology, with cellular or Wi-Fi service, to securely transmit data from their pacemakers to their physicians, who can then interpret the data to make treatment decisions.

The MyCareLink Smart Monitor is comprised of a handheld portable device reader, prescribed by a physician, 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, patients can initiate a transmission of pacemaker data by securely uploading the information to the Medtronic CareLink® Network, the world’s leading remote monitoring service for cardiac device patients, currently being used by more than 1 million patients.

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;i less time spent at a doctor’s office or clinic for regular checks of the pacemaker;ii,iiireduced time spent in the hospital if the physician quickly detects and treats a medical problem and a potential increase in patient survival rates.

Physician comments

“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. “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.”

Company comments

“The use of smart technology continues to grow among people of all ages, and especially among people over 65 which is the age range of the majority of our pacemaker patients,” said Darrell Johnson, vice president and general manager of the Connected Care business in the Cardiac and Vascular Group at Medtronic. “As a leader in remote cardiac monitoring, Medtronic is committed to providing cardiac patients with the latest technology to improve their health and make their lives easier, while helping to reduce the costs of healthcare. The MyCareLink Smart Monitor is just the first of many innovative solutions we are developing that leverage smart technology to increase patient engagement.”

Source: Medtronic plc

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