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FDA Expresses Continuing Concerns About Getinge/Maquet CV Devices

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FDA Expresses Continuing Concerns About Getinge/Maquet CV Devices

May 08, 2024

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

News Daily News

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

October 17, 2023

Generic Dabigatran Lots Pulled for Nitrosamine Impurity

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Generic Dabigatran Lots Pulled for Nitrosamine Impurity

Michael O'Riordan

March 28, 2023

A Simple Nudge Moves the Needle on Statin Prescribing

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A Simple Nudge Moves the Needle on Statin Prescribing

Michael O'Riordan

December 02, 2022

FDA: New Fix Available for Medtronic’s Troubled HeartWare VADs

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FDA: New Fix Available for Medtronic’s Troubled HeartWare VADs

Michael O'Riordan

October 17, 2022

Class I Recall for Cordis’ Super Torque Catheters with Radiopaque Markers

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Class I Recall for Cordis’ Super Torque Catheters with Radiopaque Markers

Michael O'Riordan

September 23, 2021

Uptick in ‘Implausible’ Cancers Reported After ARB Recalls

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Uptick in ‘Implausible’ Cancers Reported After ARB Recalls

August 20, 2021

Medtronic Vascular Recalls Angiographic Guidewire Components

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Medtronic Vascular Recalls Angiographic Guidewire Components

July 02, 2021

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

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

Yael L. Maxwell

April 12, 2021

FDA Issues Class I Recall for Emblem S-ICD Over Electrode Fractures

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FDA Issues Class I Recall for Emblem S-ICD Over Electrode Fractures

Michael O'Riordan

February 12, 2021

CMS Releases Proposed Updates for Coverage of Transcatheter MV Repair

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CMS Releases Proposed Updates for Coverage of Transcatheter MV Repair

July 01, 2020

European Regulators Approve First Transcatheter MV Replacement Device

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European Regulators Approve First Transcatheter MV Replacement Device

Michael O'Riordan

January 30, 2020

FDA Warns of Potential Medical Device Shortage Due to Sterilization Woes

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FDA Warns of Potential Medical Device Shortage Due to Sterilization Woes

Yael L. Maxwell

October 25, 2019

FDA Class I Recall for PTA Catheters Due to Unexpected Balloon Bursting

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FDA Class I Recall for PTA Catheters Due to Unexpected Balloon Bursting

Yael L. Maxwell

June 18, 2019

FDA Warns of Premature Battery Depletion With Certain Medtronic Pacemakers

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FDA Warns of Premature Battery Depletion With Certain Medtronic Pacemakers

Michael O'Riordan

May 07, 2019

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

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

February 19, 2019

FDA Touts Increased Oversight of Medical Device Makers

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FDA Touts Increased Oversight of Medical Device Makers

Michael O'Riordan

November 22, 2018

FDA’s ‘Medical Device Safety Action Plan’ Focuses on Product Life Cycles and Preventing Cyberattacks

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FDA’s ‘Medical Device Safety Action Plan’ Focuses on Product Life Cycles and Preventing Cyberattacks

April 20, 2018

Inferior Vena Cava Filter Use Fell After FDA Warning but Remains High

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Inferior Vena Cava Filter Use Fell After FDA Warning but Remains High

July 12, 2017

News Daily News

Under Surveillance: Ballooning Numbers, Better Survival, Lower-Risk Patients in Latest TVT Registry Data

December 13, 2016

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