Medtronic launch newly-FDA approved MyCareLink Smart app-based monitor


Medtronic has announced that the US Food and Drug Administration (FDA) has approved MyCareLink Smart monitor, which has now been launched commercially in the USA. According to Medtronic, this is the world’s first app-based remote monitoring system for patients with implantable pacemakers.

Patients with a Medtronic pacemaker can use the MyCareLink smart monitor, in conjunction with their own smartphone or tablet, to transmit data from their pacemakers to their physicians.

“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,” says George Crossley, III, 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 via the technology that they are using every day.”

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 and Apple platforms. According to Medtronic, 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.

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 personalised 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

According to Medtronic, 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, and a potential increase in patient survival rates.