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Andexanet Alfa Pulled From US Market

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Andexanet Alfa Pulled From US Market

December 22, 2025

Abiomed Recalls Labeling for Left-Sided Impella Pumps: FDA

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Abiomed Recalls Labeling for Left-Sided Impella Pumps: FDA

March 21, 2024

FDA: No Signs of Link Between GLP-1s and Suicidal Thoughts, Actions

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FDA: No Signs of Link Between GLP-1s and Suicidal Thoughts, Actions

January 12, 2024

Biden White House Delays Decision on Menthol Ban

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Biden White House Delays Decision on Menthol Ban

Michael O'Riordan

December 07, 2023

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

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

October 17, 2023

GLP-1 Meds Linked to 265 Reports to FDA of Suicidal Ideation: Reuters

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GLP-1 Meds Linked to 265 Reports to FDA of Suicidal Ideation: Reuters

September 28, 2023

Label for Impella RP Flex Catheters Recalled to Address Anticoagulant Confusion: FDA

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Label for Impella RP Flex Catheters Recalled to Address Anticoagulant Confusion: FDA

August 18, 2023

Impella RP Mortality Rate No Longer a Concern, FDA Says

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Impella RP Mortality Rate No Longer a Concern, FDA Says

December 05, 2022

FDA: Class I Recall of Cobalt and Crome ICDs and CRT-Ds Due to Reduced-Energy Shock

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FDA: Class I Recall of Cobalt and Crome ICDs and CRT-Ds Due to Reduced-Energy Shock

August 19, 2022

HawkOne Directional Atherectomy System Recalled Due to Risk of Tip Breakage

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HawkOne Directional Atherectomy System Recalled Due to Risk of Tip Breakage

January 21, 2022

Lotus Edge TAVR Device Recalled and Discontinued Worldwide

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Lotus Edge TAVR Device Recalled and Discontinued Worldwide

Michael O'Riordan

November 18, 2020

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

FDA Advisors Recommend CVD Event Reduction Claim for Icosapent Ethyl

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FDA Advisors Recommend CVD Event Reduction Claim for Icosapent Ethyl

Michael O'Riordan

November 14, 2019

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

TCTMD’s Top 10 Most Popular Stories for May 2019

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TCTMD’s Top 10 Most Popular Stories for May 2019

May 31, 2019

FDA Provides Update on Poorer Survival With Impella RP in Postmarket Setting

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FDA Provides Update on Poorer Survival With Impella RP in Postmarket Setting

May 21, 2019

FDA: Some Tainted Losartan Must Remain on US Market to Maintain Adequate Access for Patients

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FDA: Some Tainted Losartan Must Remain on US Market to Maintain Adequate Access for Patients

March 21, 2019

FDA Provides Update on Tainted ARB Investigation, With New Impurity Found

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FDA Provides Update on Tainted ARB Investigation, With New Impurity Found

March 04, 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’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

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