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News Opinion Off Script

Evoque and Patisiran: A Tale of Two Regulatory Journeys

Sanjay Kaul, MD

March 29, 2024

News Daily News

Abiomed Recalls Labeling for Left-Sided Impella Pumps: FDA

Caitlin E. Cox

March 21, 2024

News Daily News

FDA Scolds Abiomed for Not Seeking a PMA for Its Web-Based User Portal

Caitlin E. Cox

October 17, 2023

News Daily News

CMS Issues Proposed Coverage Decision to Broaden Access for Carotid Stenting

L.A. McKeown

July 12, 2023

News Daily News

Medical Devices Cleared on Faulty Predicates More Likely to be Recalled

Michael O'Riordan

January 17, 2023

News Daily News

Impella RP Mortality Rate No Longer a Concern, FDA Says

Caitlin E. Cox

December 05, 2022

News Daily News

FDA: Class I Recall of Cobalt and Crome ICDs and CRT-Ds Due to Reduced-Energy Shock

L.A. McKeown

August 19, 2022

News Daily News

Lotus Edge TAVR Device Recalled and Discontinued Worldwide

Michael O'Riordan

November 18, 2020

News Daily News

Medtronic Recalls Parts of Its HeartWare VAD System

Todd Neale

May 29, 2020

News Daily News

European Regulators Approve First Transcatheter MV Replacement Device

Michael O'Riordan

January 30, 2020

News Daily News

FDA Expands TAVR Indication to Low-Risk Patients

Michael O'Riordan

August 16, 2019

News Daily News

New Recall for Maquet/Datascope IABPs Due to Potential Battery Failure

Marcus A. Banks

July 24, 2019

News Daily News

FDA Provides Update on Poorer Survival With Impella RP in Postmarket Setting

Todd Neale

May 21, 2019

News Daily News

TCTMD’s Top 10 Most Popular Stories for April 2019

Shelley Wood

May 01, 2019

News Daily News

FDA Warns Against Off-label Use of Wingspan Stent System

Todd Neale

April 25, 2019

News Daily News

FDA Warns Healthcare Providers of Potential Rise in Death Rate With Impella RP

Caitlin E. Cox

February 04, 2019

News Opinion Editor's Corner

TCTMD’s Top 10 Most Popular Stories for January 2019

Caitlin E. Cox

January 31, 2019

News Daily News

FDA Alerts Doctors to Potential Late Risks With Paclitaxel-Coated Balloons and Stents in PAD

Michael O'Riordan

January 17, 2019

News Daily News

FDA Touts Increased Oversight of Medical Device Makers

Michael O'Riordan

November 22, 2018

FDA Warns of Deaths, Stroke With Latest-Generation Total Artificial Heart

News Daily News

FDA Warns of Deaths, Stroke Due to Power System Problems With Total Artificial Heart System

Lucy Hicks

August 17, 2018

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Evoque and Patisiran: A Tale of Two Regulatory Journeys

Abiomed Recalls Labeling for Left-Sided Impella Pumps: FDA

FDA Scolds Abiomed for Not Seeking a PMA for Its Web-Based User Portal

CMS Issues Proposed Coverage Decision to Broaden Access for Carotid Stenting

Medical Devices Cleared on Faulty Predicates More Likely to be Recalled

Impella RP Mortality Rate No Longer a Concern, FDA Says

FDA: Class I Recall of Cobalt and Crome ICDs and CRT-Ds Due to Reduced-Energy Shock

Lotus Edge TAVR Device Recalled and Discontinued Worldwide

Medtronic Recalls Parts of Its HeartWare VAD System

European Regulators Approve First Transcatheter MV Replacement Device

FDA Expands TAVR Indication to Low-Risk Patients

New Recall for Maquet/Datascope IABPs Due to Potential Battery Failure

FDA Provides Update on Poorer Survival With Impella RP in Postmarket Setting

TCTMD’s Top 10 Most Popular Stories for April 2019

FDA Warns Against Off-label Use of Wingspan Stent System

FDA Warns Healthcare Providers of Potential Rise in Death Rate With Impella RP

TCTMD’s Top 10 Most Popular Stories for January 2019

FDA Alerts Doctors to Potential Late Risks With Paclitaxel-Coated Balloons and Stents in PAD

FDA Touts Increased Oversight of Medical Device Makers

FDA Warns of Deaths, Stroke Due to Power System Problems With Total Artificial Heart System

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