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Presentation TCT 2025

European Transition from Medical Device Director (MDD) to Medical Device Regulation (MDR): Roadmap for the Future of Global AF Studies

Presenter: Philippe PM Garot

October 28, 2025

News Daily News

SAFE-AAA Flags Ongoing EVAR Device Risk and Urges More Surveillance

L.A. McKeown

March 16, 2023

News Daily News

FDA Alert: Possible Early Deterioration of Abbott Trifecta SAVR Valves

Todd Neale

February 27, 2023

News Daily News

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

L.A. McKeown

December 06, 2022

News Daily News

FDA Safety Communication Updates Stance on Endologix AAA Grafts

L.A. McKeown

January 13, 2022

News Daily News

New Medical Device Regulations Take Effect in Europe

Todd Neale

June 02, 2021

News Daily News

Mortality Data ‘Inadvertently Omitted’ From IN.PACT Analysis of Paclitaxel-Coated Balloons

L.A. McKeown

February 19, 2019

News Daily News

FDA: All AFX Endovascular AAA Systems Now Under Class I Recall

L.A. McKeown

October 16, 2018

News Daily News

FDA Identifies Culprit in Endovascular Graft Type III Endoleaks

L.A. McKeown

June 19, 2018

News Daily News

FDA Warns of Rising Endoleak Rates After Endovascular Aneurysm Repair

L.A. McKeown

October 02, 2017

News Daily News

Not Following NOAC Dosing Instructions Tied to Worse Clinical Outcomes

Todd Neale

December 12, 2016

News Daily News

FDA Warns of Potentially Serious Problems With Intravascular Device Coatings

Shelley Wood

November 22, 2015

News Industry News

Abiomed Announces FDA Submission of Impella 2.5, Impella CP & Impella 5.0-LD Pre-Market Approval Supplements

August 18, 2015

News Daily News

PCI前肾功能评估的方法选择很重要

L.A. McKeown

June 29, 2015

News Daily News

Method Chosen to Estimate Pre-PCI Kidney Function Matters

L.A. McKeown

June 29, 2015

News Daily News

El Método Elegido para Calcular la Función Renal Pre-PCI es Relevante

L.A. McKeown

June 29, 2015

News Industry News

Abiomed Impella 2.5 Receives FDA Approval for Elective and Urgent High Risk Percutaneous Coronary Intervention (PCI) Procedures

March 23, 2015

Video

» On Record

On Record: Does Device Regulation Need More Crosstalk to Improve Access, Safety?

July 19, 2019

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European Transition from Medical Device Director (MDD) to Medical Device Regulation (MDR): Roadmap for the Future of Global AF Studies

SAFE-AAA Flags Ongoing EVAR Device Risk and Urges More Surveillance

FDA Alert: Possible Early Deterioration of Abbott Trifecta SAVR Valves

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

FDA Safety Communication Updates Stance on Endologix AAA Grafts

New Medical Device Regulations Take Effect in Europe

Mortality Data ‘Inadvertently Omitted’ From IN.PACT Analysis of Paclitaxel-Coated Balloons

FDA: All AFX Endovascular AAA Systems Now Under Class I Recall

FDA Identifies Culprit in Endovascular Graft Type III Endoleaks

FDA Warns of Rising Endoleak Rates After Endovascular Aneurysm Repair

Not Following NOAC Dosing Instructions Tied to Worse Clinical Outcomes

FDA Warns of Potentially Serious Problems With Intravascular Device Coatings

Abiomed Announces FDA Submission of Impella 2.5, Impella CP & Impella 5.0-LD Pre-Market Approval Supplements

PCI前肾功能评估的方法选择很重要

Method Chosen to Estimate Pre-PCI Kidney Function Matters

El Método Elegido para Calcular la Función Renal Pre-PCI es Relevante

Abiomed Impella 2.5 Receives FDA Approval for Elective and Urgent High Risk Percutaneous Coronary Intervention (PCI) Procedures

On Record: Does Device Regulation Need More Crosstalk to Improve Access, Safety?

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