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Little Pre- and Postmarket Testing for Most Recalled CV Devices

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Little Pre- and Postmarket Testing for Most Recalled CV Devices

Michael O'Riordan

September 16, 2024

FDA Approves First Extravascular ICD

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FDA Approves First Extravascular ICD

Yael L. Maxwell

October 23, 2023

Aveir DR Dual-Chamber Leadless Pacemaker Wins FDA Approval

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Aveir DR Dual-Chamber Leadless Pacemaker Wins FDA Approval

July 06, 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

CV Devices in the Fast Lane: FDA’s Approval Often Rests on Early Evidence

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CV Devices in the Fast Lane: FDA’s Approval Often Rests on Early Evidence

September 05, 2018

‘The Bleeding Edge’ Documentary, Tackling Medical Device Regulation, Spurs Diverse Cardiology Reactions

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‘The Bleeding Edge’ Documentary, Tackling Medical Device Regulation, Spurs Diverse Cardiology Reactions

Yael L. Maxwell

August 17, 2018

FDA Clears Sentinel Cerebral Protection Device for Use During TAVR

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FDA Clears Sentinel Cerebral Protection Device for Use During TAVR

June 05, 2017

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