FDA

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

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

News | FDA

FDA Approves Johnson & Johnson OPSYNVI (macitentan and tadalafil) Single-Tablet Combination for Patients with Pulmonary Arterial Hypertension (PAH)

March 27, 2024 — Johnson & Johnson has announced that the U.S. Food and Drug Administration (FDA) has approved OPSYNVI – ...

March 27, 2024

Elixir Medical has announced it has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its DynamX BTK System, a novel, adaptive implant for use in the treatment of narrowed or blocked vessels below-the-knee (BTK) in patients with chronic limb-threatening ischemia (CLTI). The company reports this broadens the use of the novel bioadaptor platform technology beyond the treatment of coronary artery disease.

News | FDA

Elixir Medical Receives FDA Breakthrough Device Designation for DynamX BTK System for Below-The-Knee Arterial Disease

March 27, 2024 — Elixir Medical has announced it has been granted Breakthrough Device Designation by the U.S. Food and ...

March 27, 2024

The largest prospective registry of its kind will build upon clinical data supporting the use of plaque insights to empower clinical decision making for patients with suspected coronary artery disease

News | Artificial Intelligence

HeartFlow Initiates DECIDE Registry to Evaluate Utility of HeartFlow AI-Enabled Plaque Analysis for Patients with Suspected Coronary Artery Disease

March 27 2024 — HeartFlow, Inc., a leader in AI-driven healthcare technology, announced the launch of the DECIDE ...

March 27, 2024

WINREVAIR on top of background therapy significantly improved exercise capacity and multiple important secondary outcome measures compared to background therapy alone

News | FDA

FDA Approves Merck’s WINREVAIR, a First-in-Class Treatment for Adults with Pulmonary Arterial Hypertension

March 27, 2024 — Merck, known as MSD outside of the United States and Canada, announced that the U.S. Food and Drug ...

March 27, 2024

Medical imaging AI company receives approval for algorithms enabling incidental detection of pulmonary embolism and automatic assessment of stroke severity

News | FDA

Avicenna.AI Secures FDA Clearance for Two Healthcare AI Solutions

March 26, 2024 — Medical imaging AI company Avicenna.AI announced that it has received 510(k) clearance from the US Food ...

March 26, 2024

VIDEOS

ON-DEMAND Webinar: Maximizing Structural Heart Workflows: Harnessing the Power of CVIS and AI

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ON-DEMAND WEBINAR: Maximizing Structural Heart Workflows