The Food and Drug Administration has approved a Medtronic product that can transform a personal smartphone into a medical device capable of sending critical data from a person's pacemaker to their doctor in near-real time.
FDA approves Medtronic's MyCareLink Smart Monitor that links to cellphone
The handheld device syncs with smartphones for remote data-sharing.
November 18, 2015 at 2:13AM
This month the FDA approved Medtronic's new MyCareLink Smart Monitor, which includes a handheld sensor that reads data from pacemakers plus a smartphone app that securely transmits information from the sensor to a Medtronic database. Doctors can log on to the system and read data on heart health and device functionality once a patient sends it.
The concept of remote monitoring of patients with pacemakers is not new — Medtronic already has more than 1 million users on its CareLink Network who transmit data from their cardiac devices. The network gathers encrypted data on health events, like arrhythmia episodes, and performance diagnostics on the heart device.
On Tuesday, the Minnesota-run, Ireland-based medical device-maker announced FDA approval for the Smart Monitor, which can be waved over the chest to read data from the implanted pacemaker and then synced to a Bluetooth-enabled smartphone or tablet computer for uploading. The prescription-only monitor syncs with Apple or Android-based devices via the free Medtronic Smart Monitor app.
Older devices could only transmit over a land line, which was difficult for patients who traveled frequently or didn't have a hard-wired line at home, Medtronic spokesman Ryan Mathre said.
Nashville electrophysiologist and Medtronic researcher Dr. George Crossley III said in a news release that remote monitoring has been shown to speed up diagnoses and increase patient survival while making care of pacemaker patients more efficient.
The Smart Monitor is part of a larger migration of medical-device functions into personal electronics, driven by wide adoption — 64 percent of American adults own a smartphone, and 42 percent have a tablet computer, according to the Pew Research Center.
In September, Medtronic announced availability of a device called the MiniMed Connect, which displays data from an implanted Medtronic insulin pump and continuous glucose monitor on a smartphone. In July, St. Jude Medical in Little Canada got FDA approval to sell a spinal-cord stimulator trial system that can be controlled with a smartphone.
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