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Andexanet Alfa Pulled From US Market

News Daily News

Andexanet Alfa Pulled From US Market

December 22, 2025

FDA Drops REMS Requirement for Antihypertensive Aprocitentan

News Daily News

FDA Drops REMS Requirement for Antihypertensive Aprocitentan

Michael O'Riordan

April 09, 2025

Evoque and Patisiran: A Tale of Two Regulatory Journeys

News Opinion Off Script

Evoque and Patisiran: A Tale of Two Regulatory Journeys

Sanjay Kaul, MD

March 29, 2024

Abiomed Recalls Labeling for Left-Sided Impella Pumps: FDA

News Daily News

Abiomed Recalls Labeling for Left-Sided Impella Pumps: FDA

March 21, 2024

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

News Daily News

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

October 17, 2023

Medical Devices Cleared on Faulty Predicates More Likely to be Recalled

News Daily News

Medical Devices Cleared on Faulty Predicates More Likely to be Recalled

Michael O'Riordan

January 17, 2023

Impella RP Mortality Rate No Longer a Concern, FDA Says

News Daily News

Impella RP Mortality Rate No Longer a Concern, FDA Says

December 05, 2022

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

News Daily News

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

August 19, 2022

Lotus Edge TAVR Device Recalled and Discontinued Worldwide

News Daily News

Lotus Edge TAVR Device Recalled and Discontinued Worldwide

Michael O'Riordan

November 18, 2020

Medtronic Recalls Parts of Its HeartWare VAD System

News Daily News

Medtronic Recalls Parts of Its HeartWare VAD System

May 29, 2020

FDA: Obesity Drug Lorcaserin Exits US Market Over Cancer Concerns

News Daily News

FDA: Obesity Drug Lorcaserin Exits US Market Over Cancer Concerns

February 14, 2020

European Regulators Approve First Transcatheter MV Replacement Device

News Daily News

European Regulators Approve First Transcatheter MV Replacement Device

Michael O'Riordan

January 30, 2020

FDA Advisors Recommend CVD Event Reduction Claim for Icosapent Ethyl

News Daily News

FDA Advisors Recommend CVD Event Reduction Claim for Icosapent Ethyl

Michael O'Riordan

November 14, 2019

FDA Expands TAVR Indication to Low-Risk Patients

News Daily News

FDA Expands TAVR Indication to Low-Risk Patients

Michael O'Riordan

August 16, 2019

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

News Daily News

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

Marcus A. Banks

July 24, 2019

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

News Daily News

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

May 21, 2019

TCTMD’s Top 10 Most Popular Stories for April 2019

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TCTMD’s Top 10 Most Popular Stories for April 2019

May 01, 2019

FDA Warns Against Off-label Use of Wingspan Stent System

News Daily News

FDA Warns Against Off-label Use of Wingspan Stent System

April 25, 2019

FDA: Some Tainted Losartan Must Remain on US Market to Maintain Adequate Access for Patients

News Daily News

FDA: Some Tainted Losartan Must Remain on US Market to Maintain Adequate Access for Patients

March 21, 2019

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

News Daily News

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

February 04, 2019

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