All

AI Can Ease Cardiology Workflows, But Patient Trust Gap Remains, Report Finds

New global findings show cardiac care professionals are optimistic about AI's potential to save time and improve diagnoses, while patients remain cautious.

All

AI-Driven Coronary Physiology Software Gains FDA Clearance

The software, powered by artificial intelligence and deep learning, assesses angiography-derived coronary physiology in patients with ischemic coronary artery disease.

All

HeartBeam Arrhythmia Assessment System Earns FDA Clearance

HeartBeam announced that the FDA has granted 510(k) clearance of the HeartBeam system for comprehensive arrhythmia assessment.

All

AI Can Ease Cardiology Workflows, But Patient Trust Gap Remains, Report Finds

New global findings show cardiac care professionals are optimistic about AI's potential to save time and improve diagnoses, while patients remain cautious.

AliveCor Unveils AI-Powered Portable ECG Systems

Jun 25, 2024

AliveCor has launched the FDA-cleared KAI 12L AI technology and the Kardia 12L ECG System portable ECG solutions.

FDA Clears QT Medical PCA 500 for Acute Care

Feb 16, 2024

QT Medical announced that it has received 510(k) clearance from the FDA for PCA 500 use in an acute care setting.

FDA Clears CorVista System With CAD Add-On

Sep 18, 2023

The FDA cleared the CorVista System with CAD Add-On to evaluate the presence of significant coronary artery disease as an aid in diagnosis.

FDA Grants J-Valve TF System Breakthrough Device Designation

Aug 1, 2023

Genesis MedTech announced that its J-Valve Transfemoral (TF) System has been granted Breakthrough Device designation by the FDA.

FDA OKs AccurKardia AccurECG Analysis System

Jul 21, 2023

AccurKardia’s AccurECG Analysis System, a cloud-based and fully automated ECG interpretation software platform, has received U.S. FDA 510(k) clearance, offering customizable outputs and integration with clinical workflows.