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Another Issue Shelves Some Impella Blood Pump Controllers: FDA

News Daily News

Another Issue Shelves Some Impella Blood Pump Controllers: FDA

August 27, 2025

FDA Warns of Issue with Impella Blood Pump Controllers

News Daily News

FDA Warns of Issue with Impella Blood Pump Controllers

July 02, 2025

Coronary CTA Reimbursement for US Hospitals to Double in 2025

News Daily News

Coronary CTA Reimbursement for US Hospitals to Double in 2025

Yael L. Maxwell

November 08, 2024

FDA Expresses Continuing Concerns About Getinge/Maquet CV Devices

News Daily News

FDA Expresses Continuing Concerns About Getinge/Maquet CV Devices

May 08, 2024

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

Biden White House Delays Decision on Menthol Ban

News Daily News

Biden White House Delays Decision on Menthol Ban

Michael O'Riordan

December 07, 2023

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

European Regulators Investigating CV Safety of Weight-Loss Drug Mysimba

News Daily News

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

News Daily News

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

August 18, 2023

Cardiosave IABPs—Yet Again—the Subject of a Class I Recall: FDA

News Daily News

Cardiosave IABPs—Yet Again—the Subject of a Class I Recall: FDA

August 17, 2023

Cardiosave IABPs Recalled Again, This Time Due to Potential Electrical Problems: FDA

News Daily News

Cardiosave IABPs Recalled Again, This Time Due to Potential Electrical Problems: FDA

Michael O'Riordan

August 10, 2023

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

News Daily News

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

July 27, 2023

Abiomed Recalls Certain Impella 5.5 Devices Due to Risk of Purge-Fluid Leaks

News Daily News

Abiomed Recalls Certain Impella 5.5 Devices Due to Risk of Purge-Fluid Leaks

June 05, 2023

Another Recall Warns of Unheralded Shutdowns With Cardiosave IABPs

News Daily News

Another Recall Warns of Unheralded Shutdowns With Cardiosave IABPs

March 31, 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

A Simple Nudge Moves the Needle on Statin Prescribing

News Daily News

A Simple Nudge Moves the Needle on Statin Prescribing

Michael O'Riordan

December 02, 2022

FDA: New Fix Available for Medtronic’s Troubled HeartWare VADs

News Daily News

FDA: New Fix Available for Medtronic’s Troubled HeartWare VADs

Michael O'Riordan

October 17, 2022

Dragonfly OpStar OCT Catheter Recalled for Loose Marker Band

News Daily News

Dragonfly OpStar OCT Catheter Recalled for Loose Marker Band

May 26, 2022

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