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April 04, 2025

News Daily News

FDA Issues Safety Communication for Some Accolade Pacemakers

December 16, 2024

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

March 21, 2024

News Daily News

FDA: No Signs of Link Between GLP-1s and Suicidal Thoughts, Actions

Todd Neale

January 12, 2024

News Daily News

Asundexian’s Lack of Efficacy Sinks OCEANIC-AF

November 20, 2023

News Daily News

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

October 17, 2023

News Daily News

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

September 18, 2023

News Daily News

European Regulators Investigating CV Safety of Weight-Loss Drug Mysimba

September 15, 2023

News Daily News

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

August 18, 2023

News Daily News

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

July 27, 2023

News Daily News

Class I Recall for 350,000 Medtronic Defibrillators: FDA

July 19, 2023

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CMS Issues Proposed Coverage Decision to Broaden Access for Carotid Stenting

July 12, 2023

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FDA: All Restrictions on Paclitaxel Devices for PAD Are Removed

July 11, 2023

News Daily News

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

June 05, 2023

News Daily News

Generic Dabigatran Lots Pulled for Nitrosamine Impurity

March 28, 2023

News Daily News

Medical Devices Cleared on Faulty Predicates More Likely to be Recalled

January 17, 2023

News Daily News

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