FDA

FDA Announces Recalls of Abbott/Thoratec Corp. Heartmate II and Heartmate 3 Left Ventricular Assist System (LVAS) Due to Long-term Buildup of biological material Causing an Obstruction
April 15, 2024 — The U.S. Food and Drug Administration (FDA) announced Abbott/Thoratec Corp. is recalling HeartMate II and HeartMate 3 Left Ventricular Assist System (LVAS) due to an issue called ...
FDA Announces Medos International Sàrl Recall of Cerenovus CEREBASE DA Guide Sheath due to Cracking of the Distal Catheter Shaft
April 4, 2024 — The U.S. Food and Drug Administration (FDA) announced that Medos International Sàrl is recalling Cerenovus CEREBASE DA Guide Sheath due to a crack found in the far end of the catheter ...
Top 10: What Viewers Were Reading in March
Here is a Top 10 look at the content that was trending during the month of March on dicardiology.com: 1. CLS Health Cardiologists Achieve Historic First with Transcarotid TAVR in Southeast Houston 2 ...
FDA Announces Teleflex and Arrow International Recall of ARROW QuickFlash Radial Artery and Radial Artery/Arterial Line Catheterization Kits for Increased Resistance That May Lead to Vessel Injuries, Narrowing, or Blockage
April 3, 2024 — The U.S. Food and Drug Administration (FDA) announced that Teleflex and Arrow International are recalling the ARROW QuickFlash Radial Artery and Radial Artery/Arterial Line ...

Groundbreaking technology for the precise, automatic measurement of peripheral blood vessels to optimize treatment strategies

Provisio Medical Announces FDA Clearance of the Provisio SLT IVUS System

April 25, 2024 — Provisio Medical announced FDA 510(k) clearance of the Provisio SLT IVUS System. Sonic Lumen Tomography ...

April 25, 2024

Patent covers use of AI-ECG for any echo measure of diastolic function, which is crucial for heart screening and early detection of heart disease

News | FDA

Innovative Aspiration Thrombectomy System by Expanse ICE Receives FDA Clearance for Vessels of the Peripheral Arterial and Venous Systems

April 24, 2024 — Expanse ICE announced today the ICE Aspiration System has received 510(k) clearance from the U.S. Food ...

April 24, 2024

RCE Technologies, Inc. (RCE) is an innovative artificial intelligence (AI) based medical technology company dedicated to early heart attack detection.

News | FDA

RCE Technologies, Inc. Announces First-In-Human Transdermal Continuous Cardiac Biomarker Monitoring

April 22, 2024 — At the annual American College of Cardiology conference (ACC.24) in Atlanta last week, RCE Technologies ...

April 22, 2024

AB-1002 is being studied for the treatment of adults with non-ischemic cardiomyopathy and New York Heart Association (NYHA) Class III heart failure symptoms

News | FDA

AskBio Receives FDA Fast Track Designation for AB-1002 Investigational Gene Therapy Program in Congestive Heart Failure

April 18, 2024 — Bayer AG and Asklepios BioPharmaceutical, Inc., a gene therapy company wholly owned and independently ...

April 18, 2024

Abbott/Thoratec Corp. is recalling HeartMate II and HeartMate 3 Left Ventricular Assist System (LVAS) due to an issue called Extrinsic Outflow Graft Obstruction, (EOGO).

News | FDA

FDA Announces Recalls of Abbott/Thoratec Corp. Heartmate II and Heartmate 3 Left Ventricular Assist System (LVAS) Due to Long-term Buildup of biological material Causing an Obstruction

April 15, 2024 — The U.S. Food and Drug Administration (FDA) announced Abbott/Thoratec Corp. is recalling HeartMate II ...

April 15, 2024

The Acolyte System is intended to provide interventional cardiologists with a more reliable and predictable tool to facilitate revascularization of chronic total occlusion (CTO)

News | FDA

Simpson Interventions Receives FDA Breakthrough Device Designation for Acolyte Image Guided Crossing and Re-Entry Catheter System

April 12, 2024 — Simpson Interventions, Inc., a pioneering medical technology company specializing in cardiovascular ...

April 12, 2024

UC Davis is one of the first sites nationwide to treat tricuspid regurgitation using a minimally invasive catheter system

News | Structural Heart

Cardiology Team Performs Novel Heart Artery Repair with Newly Approved Device

April 9, 2024 — UC Davis Health cardiology team members are among the first in the country to treat patients with tricus ...

April 09, 2024

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

News | Balloon Catheter

FDA Announces Medos International Sàrl Recall of Cerenovus CEREBASE DA Guide Sheath due to Cracking of the Distal Catheter Shaft

April 4, 2024 — The U.S. Food and Drug Administration (FDA) announced that Medos International Sàrl is recalling Cerenov ...

April 04, 2024

Here is a look at the most-read content during the month of March on dicardiology.com

Feature | Cardiovascular Business | By Melinda Taschetta-Millane

Top 10: What Viewers Were Reading in March

Here is a Top 10 look at the content that was trending during the month of March on dicardiology.com:

1. CLS Health ...

April 04, 2024

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries, serious health consequences, or death

News | Catheters

FDA Announces Teleflex and Arrow International Recall of ARROW QuickFlash Radial Artery and Radial Artery/Arterial Line Catheterization Kits for Increased Resistance That May Lead to Vessel Injuries, Narrowing, or Blockage

April 3, 2024 — The U.S. Food and Drug Administration (FDA) announced that Teleflex and Arrow International are ...

April 03, 2024

Concept Medical has received FDA IDE Approval for a US Clinical Study of its MagicTouch AVF, its Sirolimus drug-coated balloon (DCB) catheter..

News | FDA

Concept Medical Receives FDA IDE Approval for US Clinical Study of MagicTouch AVF Indication

April 2, 2024 — Medical device technology developer Concept Medical has announced it has been granted Investigational ...

April 02, 2024

Abbott has announced U.S Food and Drug Administration (FDA) approval of its TriClip, a first-of-its-kind device to repair leaky tricuspid heart valve.

News | FDA

Abbott Announces FDA Approval of First-of-its-kind Device to Repair Leaky Tricuspid Heart Valve, TriClip

April 2, 2024 — Abbott announced that the U.S. Food and Drug Administration (FDA) approved the company's first-of-its ...

April 02, 2024

News | FDA

U.S. FDA Approves Broad New Labels for NEXLETOL and NEXLIZET to Prevent Heart Attacks and Cardiovascular Procedures in Both Primary and Secondary Prevention Patients, Regardless of Statin Use

April 1, 2024 — Esperion announced that the United States Food and Drug Administration (FDA) has approved broad new ...

April 01, 2024

The Evolut FX+ TAVR system leverages market-leading valve performance with addition of larger windows to facilitate coronary access

News | FDA

Medtronic Announces FDA Approval of Newest-generation Evolut TAVR System for Treatment of Symptomatic Severe Aortic Stenosis

March 28, 2024 — Medtronic plc, a global leader in healthcare technology, announced that the United States Food and Drug ...

March 28, 2024

Findings from the admIRE study – freedom from atrial arrhythmia recurrence at 12 months – support the submission of the VARIPULSE Platform among U.S. patients

News | Atrial Fibrillation

Biosense Webster Submits Application to U.S. FDA Seeking Approval of the VARIPULSE Platform for the Treatment of Paroxysmal Atrial Fibrillation

March 28, 2024 — Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson ...

March 28, 2024