Medtronic’s MyCareLink smart monitor for pacemakers gets FDA approval

17 November 2015 (Last Updated November 17th, 2015 18:30)

The US Food and Drug Administration (FDA) has granted approval for Irish medical technology firm Medtronic's MyCareLink smart monitor, an app-based remote monitoring system for patients with implantable pacemakers.

The US Food and Drug Administration (FDA) has granted approval for Irish medical technology firm Medtronic's MyCareLink smart monitor, an app-based remote monitoring system for patients with implantable pacemakers.

MyCareLink allows Medtronic pacemaker patients to use their own smartphone or tablet technology with cellular or Wi-Fi service to securely transmit data from their pacemakers to their physicians, who will interpret data to make treatment decisions.

The system features a handheld portable device reader and smart mobile app, which is free on both Android and Apple platforms.

Patients can start transmission of pacemaker data by securely uploading information to the Medtronic CareLink network, when the MyCareLink smart monitor is connected to cellular or Wi-Fi service.

Vanderbilt Heart and Vascular Institution associate professor of medicine George Crossley said: "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.

"This innovation will serve as the foundation for future advances using smart technology to support cardiac patients."

"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."

MyCareLink Smart Monitor will confirm the date of their most recent transmission of pacemaker information.

The system will also create a personalised profile on the MyCareLink Connect website to manage their pacemaker information and data transmission, and receives email or text reminders, confirmations and notifications of their data transmissions.

Medtronic in collaboration with leading clinicians, researchers and scientists worldwide offers a range of new medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias.