Novel ICE System for Intracardiac Echocardiography Receives US FDA Clearance
By MedImaging International staff writers Posted on 20 Jan 2016 |
A novel catheter-based ultrasound system that provides ultrasound images of cardiac anatomy around the tip of the catheter has received US Food and Drug Administration (FDA) 510(k) clearance.
The system is intended for use in intracardiac and intraluminal ultrasound imaging of the anatomy of the heart and associated great vessel anatomy. The system is the first catheter-based ultrasound system that can provide both 2D and 3D images of cardiac anatomy around the catheter’s tip.
The Foresight ICE system is made by Conavi Medical, formerly Colibri Technologies (Toronto, Canada), and includes Conavi’s dual-display Hummingbird imaging console, and the Foresight ICE catheter. The system supports minimally invasive cardiovascular procedures, for example ablations, that may require access to targeted areas of the heart.
"FDA clearance of the Foresight ICE System represents a major milestone for Conavi's team and our customers in the US healthcare system," says Brian Courtney, CEO of Conavi Medical Inc. "We look forward to working with physicians in the United States by providing them with new visualization tools to support existing and emerging minimally invasive procedures for patients with a broad range of cardiac conditions. The Foresight ICE system represents Conavi's lead product in its commercialization pipeline. The advanced technology in this system provides us with a remarkable platform from which we will be able to expand in the future to help physicians, healthcare systems, and industry partners better address a large number of clinical needs."
Related Links:
Conavi Medical (Colibri Technologies)
The system is intended for use in intracardiac and intraluminal ultrasound imaging of the anatomy of the heart and associated great vessel anatomy. The system is the first catheter-based ultrasound system that can provide both 2D and 3D images of cardiac anatomy around the catheter’s tip.
The Foresight ICE system is made by Conavi Medical, formerly Colibri Technologies (Toronto, Canada), and includes Conavi’s dual-display Hummingbird imaging console, and the Foresight ICE catheter. The system supports minimally invasive cardiovascular procedures, for example ablations, that may require access to targeted areas of the heart.
"FDA clearance of the Foresight ICE System represents a major milestone for Conavi's team and our customers in the US healthcare system," says Brian Courtney, CEO of Conavi Medical Inc. "We look forward to working with physicians in the United States by providing them with new visualization tools to support existing and emerging minimally invasive procedures for patients with a broad range of cardiac conditions. The Foresight ICE system represents Conavi's lead product in its commercialization pipeline. The advanced technology in this system provides us with a remarkable platform from which we will be able to expand in the future to help physicians, healthcare systems, and industry partners better address a large number of clinical needs."
Related Links:
Conavi Medical (Colibri Technologies)
Latest Ultrasound News
- Diagnostic System Automatically Analyzes TTE Images to Identify Congenital Heart Disease
- Super-Resolution Imaging Technique Could Improve Evaluation of Cardiac Conditions
- First AI-Powered POC Ultrasound Diagnostic Solution Helps Prioritize Cases Based On Severity
- Largest Model Trained On Echocardiography Images Assesses Heart Structure and Function
- Groundbreaking Technology Enables Precise, Automatic Measurement of Peripheral Blood Vessels
- Deep Learning Advances Super-Resolution Ultrasound Imaging
- Novel Ultrasound-Launched Targeted Nanoparticle Eliminates Biofilm and Bacterial Infection
- AI-Guided Ultrasound System Enables Rapid Assessments of DVT
- Focused Ultrasound Technique Gets Quality Assurance Protocol
- AI-Guided Handheld Ultrasound System Helps Capture Diagnostic-Quality Cardiac Images
- Non-Invasive Ultrasound Imaging Device Diagnoses Risk of Chronic Kidney Disease
- Wearable Ultrasound Platform Paves Way for 24/7 Blood Pressure Monitoring On the Wrist
- Diagnostic Ultrasound Enhancing Agent to Improve Image Quality in Pediatric Heart Patients
- AI Detects COVID-19 in Lung Ultrasound Images
- New Ultrasound Technology to Revolutionize Respiratory Disease Diagnoses
- Dynamic Contrast-Enhanced Ultrasound Highly Useful For Interventions