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Andexanet Alfa Pulled From US Market

News Daily News

Andexanet Alfa Pulled From US Market

December 22, 2025

Reduced Shock Efficacy With Some Boston Scientific Defibrillation Leads

News Daily News

Reduced Shock Efficacy With Some Boston Scientific Defibrillation Leads

August 06, 2025

DETECT-AS: Alert System Increases AV Replacement in Eligible Patients

News Conference News ACC 2025

DETECT-AS: Alert System Increases AV Replacement in Eligible Patients

Michael O'Riordan

April 04, 2025

Coronary CTA Reimbursement for US Hospitals to Double in 2025

News Daily News

Coronary CTA Reimbursement for US Hospitals to Double in 2025

Yael L. Maxwell

November 08, 2024

Device Correction Issued for HeartMate Monitor Due to Potential Pump Stoppage

News Daily News

Device Correction Issued for HeartMate Monitor Due to Potential Pump Stoppage

June 28, 2024

FDA Expresses Continuing Concerns About Getinge/Maquet CV Devices

News Daily News

FDA Expresses Continuing Concerns About Getinge/Maquet CV Devices

May 08, 2024

EMA: No Evidence of Link Between GLP-1 Receptor Agonists and Suicidal Thoughts

News Daily News

EMA: No Evidence of Link Between GLP-1 Receptor Agonists and Suicidal Thoughts

April 12, 2024

Class I Recall for 330,000 Radial Artery Catheterization Kits: FDA

News Daily News

Class I Recall for 330,000 Radial Artery Catheterization Kits: FDA

Yael L. Maxwell

April 03, 2024

Evoque and Patisiran: A Tale of Two Regulatory Journeys

News Opinion Off Script

Evoque and Patisiran: A Tale of Two Regulatory Journeys

Sanjay Kaul, MD

March 29, 2024

Abiomed Recalls Labeling for Left-Sided Impella Pumps: FDA

News Daily News

Abiomed Recalls Labeling for Left-Sided Impella Pumps: FDA

March 21, 2024

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

News Daily News

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

January 12, 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

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

News Daily News

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

September 28, 2023

European Regulators Investigating CV Safety of Weight-Loss Drug Mysimba

News Daily News

European Regulators Investigating CV Safety of Weight-Loss Drug Mysimba

Michael O'Riordan

September 15, 2023

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

News Daily News

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

August 18, 2023

Cardiosave IABPs—Yet Again—the Subject of a Class I Recall: FDA

News Daily News

Cardiosave IABPs—Yet Again—the Subject of a Class I Recall: FDA

August 17, 2023

Cardiosave IABPs Recalled Again, This Time Due to Potential Electrical Problems: FDA

News Daily News

Cardiosave IABPs Recalled Again, This Time Due to Potential Electrical Problems: FDA

Michael O'Riordan

August 10, 2023

FDA: Class I Recall for Left-Sided Impella Pumps Due to TAVI Interaction

News Daily News

FDA: Class I Recall for Left-Sided Impella Pumps Due to TAVI Interaction

July 27, 2023

Class I Recall for Amplatzer LAAO's Steerable Delivery Sheath

News Daily News

Class I Recall for Amplatzer LAAO's Steerable Delivery Sheath

July 26, 2023

Class I Recall for 350,000 Medtronic Defibrillators: FDA

News Daily News

Class I Recall for 350,000 Medtronic Defibrillators: FDA

Michael O'Riordan

July 19, 2023

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