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Andexanet Alfa Pulled From US Market

Todd Neale

December 22, 2025

News Daily News

FDA Warns of Air Embolism Risk With Watchman LAAO Access Systems

Todd Neale

August 06, 2025

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

Caitlin E. Cox

March 21, 2024

News Daily News

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

Caitlin E. Cox

October 17, 2023

News Daily News

FDA: All Restrictions on Paclitaxel Devices for PAD Are Removed

L.A. McKeown

July 11, 2023

News Daily News

Another Recall Warns of Unheralded Shutdowns With Cardiosave IABPs

Shelley Wood

March 31, 2023

News Daily News

FDA, Abbott Warn of Potential MitraClip Locking Malfunctions

L.A. McKeown

September 09, 2022

News Daily News

Medtronic Recalls TurboHawk Plus Atherectomy System

Todd Neale

March 09, 2022

News Daily News

HawkOne Directional Atherectomy System Recalled Due to Risk of Tip Breakage

L.A. McKeown

January 21, 2022

News Daily News

FDA Safety Communication Updates Stance on Endologix AAA Grafts

L.A. McKeown

January 13, 2022

News Daily News

Uptick in ‘Implausible’ Cancers Reported After ARB Recalls

L.A. McKeown

August 20, 2021

News Daily News

FDA: Another Class I Recall for HeartWare VAD

Shelley Wood

April 16, 2021

News Daily News

FDA: Class I Recall for Seven Models of Medtronic ICDs and CRT-Ds

Yael L. Maxwell

April 12, 2021

News Features

Hydroxychloroquine: No Help, Clear Harm in COVID-19 RCT and Cohort Studies

Shelley Wood

May 20, 2020

News Daily News

FDA: New Concerns Surface With Endologix Grafts for AAA

L.A. McKeown

October 28, 2019

News Daily News

FDA: Class I Recall for Burst Balloons With Sapien 3 Ultra Delivery System

Michael O'Riordan

August 22, 2019

News Opinion Editor's Corner

TCTMD’s Top 10 Most Popular Stories for May 2019

Caitlin E. Cox

May 31, 2019

News Daily News

FDA Tallies Cases of Fournier Gangrene in Patients Taking SGLT2 Inhibitors

Michael O'Riordan

May 08, 2019

News Daily News

FDA Warns of Premature Battery Depletion With Certain Medtronic Pacemakers

Michael O'Riordan

May 07, 2019

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Andexanet Alfa Pulled From US Market

FDA Warns of Air Embolism Risk With Watchman LAAO Access Systems

Evoque and Patisiran: A Tale of Two Regulatory Journeys

Abiomed Recalls Labeling for Left-Sided Impella Pumps: FDA

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

FDA: All Restrictions on Paclitaxel Devices for PAD Are Removed

Another Recall Warns of Unheralded Shutdowns With Cardiosave IABPs

FDA, Abbott Warn of Potential MitraClip Locking Malfunctions

Medtronic Recalls TurboHawk Plus Atherectomy System

HawkOne Directional Atherectomy System Recalled Due to Risk of Tip Breakage

FDA Safety Communication Updates Stance on Endologix AAA Grafts

Uptick in ‘Implausible’ Cancers Reported After ARB Recalls

FDA: Another Class I Recall for HeartWare VAD

FDA: Class I Recall for Seven Models of Medtronic ICDs and CRT-Ds

Hydroxychloroquine: No Help, Clear Harm in COVID-19 RCT and Cohort Studies

FDA: New Concerns Surface With Endologix Grafts for AAA

FDA: Class I Recall for Burst Balloons With Sapien 3 Ultra Delivery System

TCTMD’s Top 10 Most Popular Stories for May 2019

FDA Tallies Cases of Fournier Gangrene in Patients Taking SGLT2 Inhibitors

FDA Warns of Premature Battery Depletion With Certain Medtronic Pacemakers

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