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Andexanet Alfa Pulled From US Market

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Andexanet Alfa Pulled From US Market

December 22, 2025

Another Issue Shelves Some Impella Blood Pump Controllers: FDA

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Another Issue Shelves Some Impella Blood Pump Controllers: FDA

August 27, 2025

Reduced Shock Efficacy With Some Boston Scientific Defibrillation Leads

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Reduced Shock Efficacy With Some Boston Scientific Defibrillation Leads

August 06, 2025

FDA Warns of Issue with Impella Blood Pump Controllers

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FDA Warns of Issue with Impella Blood Pump Controllers

July 02, 2025

Coronary CTA Reimbursement for US Hospitals to Double in 2025

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Coronary CTA Reimbursement for US Hospitals to Double in 2025

Yael L. Maxwell

November 08, 2024

Biden White House Delays Decision on Menthol Ban

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Biden White House Delays Decision on Menthol Ban

Michael O'Riordan

December 07, 2023

‘Overwhelming Reduction’ in Bleeding With Abelacimab vs Rivaroxaban in AF

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‘Overwhelming Reduction’ in Bleeding With Abelacimab vs Rivaroxaban in AF

September 18, 2023

European Regulators Investigating CV Safety of Weight-Loss Drug Mysimba

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European Regulators Investigating CV Safety of Weight-Loss Drug Mysimba

Michael O'Riordan

September 15, 2023

Label for Impella RP Flex Catheters Recalled to Address Anticoagulant Confusion: FDA

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Label for Impella RP Flex Catheters Recalled to Address Anticoagulant Confusion: FDA

August 18, 2023

FDA: Class I Recall for Left-Sided Impella Pumps Due to TAVI Interaction

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FDA: Class I Recall for Left-Sided Impella Pumps Due to TAVI Interaction

July 27, 2023

Class I Recall for 350,000 Medtronic Defibrillators: FDA

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Class I Recall for 350,000 Medtronic Defibrillators: FDA

Michael O'Riordan

July 19, 2023

Generic Dabigatran Lots Pulled for Nitrosamine Impurity

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Generic Dabigatran Lots Pulled for Nitrosamine Impurity

Michael O'Riordan

March 28, 2023

Medical Devices Cleared on Faulty Predicates More Likely to be Recalled

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Medical Devices Cleared on Faulty Predicates More Likely to be Recalled

Michael O'Riordan

January 17, 2023

FDA: Endologix AAA Grafts Get New Labeling That Addresses Endoleak Potential

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FDA: Endologix AAA Grafts Get New Labeling That Addresses Endoleak Potential

December 06, 2022

Impella RP Mortality Rate No Longer a Concern, FDA Says

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Impella RP Mortality Rate No Longer a Concern, FDA Says

December 05, 2022

A Simple Nudge Moves the Needle on Statin Prescribing

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A Simple Nudge Moves the Needle on Statin Prescribing

Michael O'Riordan

December 02, 2022

FDA Safety Communication Updates Stance on Endologix AAA Grafts

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FDA Safety Communication Updates Stance on Endologix AAA Grafts

January 13, 2022

Class I Recall of Batteries for Cardiosave Hybrid/Rescue IABPs: FDA

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Class I Recall of Batteries for Cardiosave Hybrid/Rescue IABPs: FDA

October 29, 2021

FDA Investigating Possible Sex Differences in LAAO Outcomes

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FDA Investigating Possible Sex Differences in LAAO Outcomes

September 27, 2021

Papers Probe Temporal Link Between COVID-19 Vaccines and Myocarditis

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Papers Probe Temporal Link Between COVID-19 Vaccines and Myocarditis

Michael O'Riordan

June 17, 2021

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