FDA

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

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

The U.S. Food and Drug Administration (FDA) is providing an update to the February 27, 2023 Letter to Health Care Providers about the potential risk of early structural valve deterioration (SVD) with Abbott Trifecta valves, including the Trifecta Valve and Trifecta Valve with Glide Technology (GT)

News | Heart Valve Technology

FDA Issues Update on Abbott Trifecta Valves: Potential Risk of Early Structural Valve Deterioration

July 31, 2023 — Today, the U.S. Food and Drug Administration (FDA) is providing an update to the February 27, 2023 ...

July 31, 2023

AI demonstrated high accuracy, reduced non-diagnostic outputs, and identified HFpEF patients with worse outcomes.

News | Cardiovascular Clinical Studies

Study Confirms Ultromics' AI Can Improve HFpEF Detection Using a Single Echocardiogram View

July 31, 2023 — Applying AI to a single apical four chamber (A4C) view echocardiogram provides accurate information to ...

July 31, 2023

GE HealthCare is recalling malfunctioning TruSignal sensors that may reduce the amount of energy sent to the heart during defibrillation without any notification to the care provider

News | Defibrillator Monitors

GE HealthCare Recalls TruSignal SpO2 Sensors for Issues That May Reduce Defibrillation Energy, Expose Patients to Unintended Voltage, or Give Inaccurate Readings

July 28, 2023 — GE HealthCare is recalling malfunctioning TruSignal sensors that may reduce the amount of energy sent to ...

July 28, 2023

Primary endpoints across three studies underscore the importance of accuracy, utility, and efficiency in coronary artery disease diagnostics and clinical decision making

News | Cardiovascular Clinical Studies

HeartFlow to Announce New Data at SCCT23

July 28, 2023 — Respective results from the REVEALPLAQUE, DECODE, and SMART-CT clinical studies demonstrate the accuracy ...

July 28, 2023