Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech

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

November 17, 2015 By Medtronic

Medtronic plc today announced U.S. Food and Drug Administration (FDA) approval and U.S. commercial availability of the MyCareLink Smart Monitor, the world’s first app-based remote monitoring system for patients with implantable pacemakers. With the MyCareLink Smart Monitor, 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.

“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.”

The MyCareLink Smart reader with cell phone and tablet

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. 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 CareLinkNetwork, 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;1 less time spent at a doctor’s office or clinic for regular checks of the pacemaker;2,3 reduced time spent in the hospital if the physician quickly detects and treats a medical problem;4,5 and a potential increase in patient survival rates.6,7,8

The MyCareLink Smart Reader

“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.”

In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world.

References
1Crossley GH, et al. J Am Coll Cardiol. 2011;57:1181-1189.
2Cronin EM, et al. Heart Rhythm. 2012;9:1947-1951.
3Varma N, et al. Am Heart J. 2007;154:1029-1034
4Crossley GH, et al. J Am Coll Cardiol. 2011;57:1181-1189.
5Akar J, et al. LB03-03 Presented at HRS 2014.
6Saxon LA, et al. Circulation. 2010;122:2359-2367.
7Mittal S, et al. LB01-05 Presented at HRS 2014.
8Akar J, et al. LB03-03 Presented at HRS 2014.

Related Articles Read More >

A portrait of Dr. Philip Adamson
Expect more heart and lung failure years after COVID, Abbott’s heart failure CMO says
iRhythm stays silent on federal grand jury subpoenas
iRhythm stock soars on Street-beating Q1
A Medtronic HVAD pump opened up to show the inner workings
Medtronic investigates HVAD pump welds after patient deaths

DeviceTalks Weekly.

May 13, 2022
Our Pre-Post-DeviceTalks Boston episode, also MedtronicTalks replay with Gastro CMO Austin Chiang
See More >

MDO Digital Edition

Digital Edition

Subscribe to Medical Design & Outsourcing. Bookmark, share and interact with the leading medical design engineering magazine today.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
DeviceTalks

DeviceTalks is a conversation among medical technology leaders. It's events, podcasts, webinars and one-on-one exchanges of ideas & insights.

DeviceTalks

New MedTech Resource

Medical Tubing

Enewsletter Subscriptions

Enewsletter Subscriptions

MassDevice

Mass Device

The Medical Device Business Journal. MassDevice is the leading medical device news business journal telling the stories of the devices that save lives.

Visit Website
MDO ad
Medical Design and Outsourcing
  • MassDevice
  • DeviceTalks
  • MedTech 100 Index
  • Medical Tubing + Extrusion
  • Drug Delivery Business News
  • Drug Discovery & Development
  • Pharmaceutical Processing World
  • R&D World
  • About Us/Contact
  • Advertise With Us
  • Subscribe to Print Magazine
  • Subscribe to E-newsletter
  • Attend our Monthly Webinars
  • Listen to our Weekly Podcasts
  • Join our DeviceTalks Tuesdays Discussion

Copyright © 2022 WTWH Media, LLC. All Rights Reserved. Site Map | Privacy Policy | RSS

Search Medical Design & Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech