FDA

Magenta Medical, developer of the Elevate heart pump system, an FDA Designated Breakthrough Device, recently announced the completion of its FDA-approved Early Feasibility Study for the high-risk percutaneous coronary intervention (HR-PCI) indication.

Magenta Medical Completes Enrollment to Early Feasibility Study for World’s Smallest Heart Pump

September 6, 2023 — Magenta Medical, developer of the Elevate heart pump system, an FDA Designated Breakthrough Device ...

September 06, 2023

Abiomed is recalling the labeling for Impella RP Flex with Smart Assist System Catheter

News | FDA

Abiomed Recalls the Labeling for Impella RP Flex with SmartAssist for Risk of Blood Clots

August 18, 2023 — The U.S. Food and Drug Administration (FDA) announced that Abiomed is recalling the labeling for ...

August 18, 2023

News | FDA

Argus Cognitive Receives FDA Clearance for 3D Echocardiographic Right Ventricular Analysis Tool

August 15, 2023 — Argus Cognitive, Inc., a digital health company that develops software medical devices, announced ...

August 15, 2023

The FDA has announced that Datascope/Maquet/Getinge is recalling the Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) because they may shutdown unexpectedly due to electrical failures in the Power Management Board and/or Solenoid Board (Power Source Path).

News | Intra-Aortic Balloon Pumps (IABP)

Datascope/Maquet/Getinge Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for Unexpected Shutdowns

August 14, 2023 — The FDA has announced that Datascope/Maquet/Getinge is recalling the Cardiosave Hybrid and Rescue ...

August 14, 2023

Partnership makes AI4MedImaging’s AI4CMR solution available on the Blackford Platform

News | Artificial Intelligence

Blackford and AI4MedImaging Announce Partnership to enhance AI solutions offering for Cardiac MRI

August 10, 2023 — Blackford, the pioneering strategic imaging AI platform and solutions provider, and AI4MedImaging, a ...

August 10, 2023

News | Artificial Intelligence

AI Breakthrough Award Presented to Cleerly CCTA Digital Care Platform

August 10, 2023 — Cleerly, an artificial intelligence (AI) digital healthcare company, recently announced it was named ...

August 10, 2023

Game-changing potential for drug testing and cardiovascular disease treatments - Tiny Heart Model carries massive implications

News | Cardiovascular Clinical Studies

Tiny, Multichambered Human Heart Model Developed by Hebrew University Researchers Could Transform Cardiovascular Research and Drug Evaluation

August 9, 2023 — A team of researchers, led by the Hebrew University of Jerusalem (HU), has developed a tiny human heart ...

August 09, 2023

Novo Nordisk A/S: Semaglutide 2.4 mg reduces the risk of major adverse cardiovascular events by 20% in adults with overweight or obesity in the SELECT trial

News | Cardiovascular Clinical Studies

Major Adverse Cardiovascular Events Reduced in Overweight/Obese Patients with Wegovy, per SELECT Trial

August 9, 2023 — Novo Nordisk announced the headline results from the SELECT cardiovascular outcomes trial. The double ...

August 09, 2023

First-of-its-kind expandable cryoballoon catheter advances cryoablation therapy, addresses key limitations with traditional systems

News

Boston Scientific Receives FDA Approval for the POLARx Cryoablation System

August 9, 2023 — Boston Scientific Corporation announced it has received U.S. Food and Drug Administration (FDA) ...

August 09, 2023

The 510(k) application covers Evie Ring’s pulse oximeter that includes heart rate and SpO2 data, and is expected to make it one of the first consumer wearables that is also cleared for clinical use

News | Wearables

Movano Health Achieves Major Milestone with First FDA Filing for Evie Ring’s Pulse Oximeter

August 7, 2023 — Movano Health, a purpose-driven healthcare solutions company at the intersection of medical and ...

August 07, 2023

News | Wearables

Biosense Webster Receives FDA Approval for Multiple Atrial Fibrillation Ablation Products to be Used in a Workflow Without Fluoroscopy

August 7, 2023 — Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson M ...

August 07, 2023

Merit’s WAVE study is a prospective, randomized, controlled, multicenter study

News | Cardiovascular Clinical Studies

Merit Medical’s WRAPSODY Arteriovenous Access Efficacy (WAVE) Pivotal Study Completes Enrollment

August 3, 2023 — Merit Medical Systems, a leading global manufacturer and marketer of healthcare technology, today ...

August 03, 2023

the U.S Food and Drug Administration (FDA) has cleared the QuikClot Control+ Hemostatic Device to include mild and moderate bleeding in cardiac surgical procedures and bone surface bleeding following a sternotomy

News | Cath Lab

Teleflex Receives FDA Clearance for Expanded Indication for QuikClot Control+ Hemostatic Device Usage in Cardiac Surgical Procedures

August 2, 2023 — Teleflex Incorporated, a leading global provider of medical technologies, announced the U.S Food and ...

August 02, 2023

LX2020 preclinical studies demonstrated proof-of-concept with treatment restoring desmosomal integrity, reducing arrhythmias, and extending survival in a clinically relevant murine model

News | Pharmaceuticals

LEXEO Therapeutics Announces FDA Clearance of IND for LX2020, an AAV-based Gene Therapy Candidate for PKP2 Arrhythmogenic Cardiomyopathy

August 1, 2023 —LEXEO Therapeutics, a clinical-stage gene therapy company advancing adeno-associated virus (AAV)-based ...

August 01, 2023

Here is a look at what DAIC viewers were reading during the month of July

Feature | Cardiovascular Business | By Melinda Taschetta-Millane

What Viewers Were Reading in July

Here is a look at what DAIC viewers were reading during the month of July:

1. Lessons Learned from World’s First ...

August 01, 2023