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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 Approves Portico TAVI Valve, Paving the Way for Third US Device

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FDA Approves Portico TAVI Valve, Paving the Way for Third US Device

September 20, 2021

FDA Approves Harmony TPV for Pulmonary-Valve Regurgitation in Congenital HD

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FDA Approves Harmony TPV for Pulmonary-Valve Regurgitation in Congenital HD

Yael L. Maxwell

March 26, 2021

FDA Approves Rivaroxaban for CV Event Reduction in CAD and PAD Patients

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FDA Approves Rivaroxaban for CV Event Reduction in CAD and PAD Patients

October 12, 2018

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

News Daily News

FDA Approves Sapien XT and Sapien 3 for Intermediate-Risk Patients

Yael L. Maxwell

August 18, 2016

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