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Andexanet Alfa Pulled From US Market

Todd Neale

December 22, 2025

News Daily News

FDA Drops REMS Requirement for Antihypertensive Aprocitentan

Michael O'Riordan

April 09, 2025

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

European Regulators Investigating CV Safety of Weight-Loss Drug Mysimba

Michael O'Riordan

September 15, 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

Papers Probe Temporal Link Between COVID-19 Vaccines and Myocarditis

Michael O'Riordan

June 17, 2021

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

FDA: Obesity Drug Lorcaserin Exits US Market Over Cancer Concerns

Shelley Wood

February 14, 2020

News Daily News

European Regulators Approve First Transcatheter MV Replacement Device

Michael O'Riordan

January 30, 2020

News Daily News

FDA Advisors Recommend CVD Event Reduction Claim for Icosapent Ethyl

Michael O'Riordan

November 14, 2019

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

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Andexanet Alfa Pulled From US Market

FDA Drops REMS Requirement for Antihypertensive Aprocitentan

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

European Regulators Investigating CV Safety of Weight-Loss Drug Mysimba

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

Papers Probe Temporal Link Between COVID-19 Vaccines and Myocarditis

Lotus Edge TAVR Device Recalled and Discontinued Worldwide

Medtronic Recalls Parts of Its HeartWare VAD System

FDA: Obesity Drug Lorcaserin Exits US Market Over Cancer Concerns

European Regulators Approve First Transcatheter MV Replacement Device

FDA Advisors Recommend CVD Event Reduction Claim for Icosapent Ethyl

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

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