Implantable Cardioverter Defibrillators (ICD)

The Unify ICD is one of the SJM devices in an FDA warning letter
Feature | Implantable Cardioverter Defibrillators (ICD) | April 14, 2017 | Dave Fornell

April 14, 2017 — The U.S. Food and Drug Administration (FDA) sent a warning letter to Abbott/St. Jude Medical (SJM)...

An electrophysiology EP ablation procedure to treat a heart arrhythmia
Feature | HRS | April 14, 2017

April 14, 2017 — The Heart Rhythm Society (HRS) has announced its late-breaking clinical trials at its annual...

Biotronik Launches New ICD Lead With Helical Design in Europe
News | Leads Implantable Devices | April 12, 2017

April 12, 2017 — Biotronik announced the European launch of a new lead for...

Videos | EP Lab | April 10, 2017

A discussion with Heart Rhythm Society (HRS) President Michael Gold, M.D., Ph.D., director of cardiology and...

Biotronik, ProMRI Configurator tool, MR-conditional cardiac devices, ProMRI SystemCheck
Technology | Implantable Cardiac Monitor (ICM) | February 14, 2017

February 14, 2017 — Biotronik has developed an online tool that streamlines the workflow for physicians selecting...

NCDR, ACC, JACC, American College of Cardiology, national trends, heart disease treatments, trends in cardiovascular care
News | Cath Lab | January 23, 2017

January 23, 2017 — Over 93 percent of heart attack patients are receiving stents within the guideline-recommended...

ICDs, implantable cardioverter defibrillators, survival rate, elderly patients, JACC study
News | Implantable Cardioverter Defibrillators (ICD) | January 17, 2017

January 17, 2017 — Of patients over age 65 who received an...

cybersecurity of ICDs, cyber security of medical devices, cybersecurity vulnerability of pacemakes, implantable cardioverter defibrillators
Feature | EP Lab | January 09, 2017 | Dave Fornell

January 9, 2017 — The U.S. Food and Drug Administration (FDA) issued a safety communication today concerning patient...

cybersecurity of ICDs, cyber security of medical devices

The FDA has concerns about the cybersecurity of implantable medical devices with wireless connections for patient monitoring or adjustments to how the device functions. Changing the function of an implantable cardioverter defibrillator (ICD) using wireless access to the device could present a major patient safety issue.

News | Information Technology | December 29, 2016 | Dave Fornell

As wearable and implantable patient monitoring or therapy devices become more sophisticated with advanced wireless...

Medtronic, Claria MRI Quad CRT-D SureScan, FDA approval
Technology | Cardiac Resynchronization Therapy Devices (CRT) | November 15, 2016

November 15, 2016 — Medtronic plc  has received U.S. Food and Drug Administration (FDA) approval for the Claria MRI ...

SJM, st. Jude Medical, FDA recall, Battery depletion, Recalls ICDs and CRT-D
Feature | Implantable Cardioverter Defibrillators (ICD) | October 25, 2016 | Dave Fornell

October 25, 2016 — St. Jude Medical is recalling 251,346 of its Fortify, Unify and Assura implantable cardioverter...

Medtronic, FDA approval, MRI, MR-conditional scanning, cardiac devices
Technology | EP Lab | October 13, 2016

October 13, 2016 — Medtronic plc is the first company to receive U.S. Food and Drug Administration (FDA) approval...

EP device cyber security, SJM, St. Jude Medical
News | EP Lab | September 07, 2016

September 7, 2016 — St. Jude Medical Inc. (SJM) has filed a lawsuit against Muddy Waters Consulting LLC, Muddy...

Merlin, Merlin@home, SJM, St. Jude Medical Merlin, cybersecurity

St. Jude Medical said recent claims of the cyber attack vulnerability of its [email protected] remote monitoring system and its implantable EP devices are not true.

Feature | EP Lab | August 29, 2016 | Dave Fornell

August 29, 2016 — Investment research firm Muddy Waters Capital released a report Aug. 25 saying it believes St....

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