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Safety Alerts
Safety Advisories Notice: Medtronic Reveal LINQ with TruRhythm (LNQ11) and LINQ II (LNQ22)
Medtronic has announced a medical device correction for the LINQ and LINQ II insertable cardiac monitors (ICMs).
June 22, 2021
Safety Alerts
Medical Device Advisories Regarding Certain Boston Scientific Pacemakers
Boston Scientific (BSC) recently announced two distinct, unrelated medical device advisories related to certain pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps).
June 21, 2021
Guidelines & Protocols
National Coverage Determination for ICD
Medicare's updated coverage policy for ICD and an overview of the revisions.
May 23, 2021
Safety Alerts
FDA Issues Communication on CIEDs and Certain Consumer Devices
The U.S. Food and Drug Administration (FDA) issued a communication on potential interactions between certain cell phones and smart watches.
May 13, 2021
Guidelines & Protocols
HRS Supports Use of New Code for Remote Programming of SCRM
HRS and ACC recommend that all Medicare Administrative Contractors (MACs), state Medicaid plans, and private health insurance companies provide coverage for remote programming of subcutaneous…
April 23, 2021
Guidelines & Protocols
HRS Outreach On Regional Payment for Remote Monitoring
April 21, 2021 – HRS has been in communication with industry regarding…
April 21, 2021
Safety Alerts
BIOTRONIK Safety Communication Regarding a Subset of ICDs and CRT-Ds
Earlier this month, BIOTRONIK announced a field safety notice that some ICDs and CRT-Ds are exhibiting premature battery depletion.
March 22, 2021
Safety Alerts
Abbott Safety Notification Regarding a Subset of Assurity and Endurity Pacemakers
Abbott announced a safety notification that some Assurity and Endurity pacemakers manufactured between 2015 and 2018 have experienced moisture ingress into the header of the…
March 19, 2021
Safety Alerts
Medtronic Safety Communication Regarding a Subset of ICDs and CRT-Ds
Medtronic has issued a follow-up to its Product Performance Note relating to battery performance for a subset of Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization…
February 8, 2021
Comment Letter
HRS Comments on Plans to Improve Medicare Access to New Technologies
April 14, 2021