ICUS urges FDA to Remove Boxed Warnings
on Ultrasound Contrast Agents;

Cites compelling scientific data demonstrating
their safety and life-saving potential.

Business Wire, August 31, 2020

To read full media release, click here.

To read the ICUS Citizen Petition, click here.



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covid 19 ceus

The global COVID-19 pandemic presents unprecedented challenges for the ultrasound community, which often finds itself on the front lines of the battle against this deadly virus. Infected patients are often critically ill and require urgent bedside imaging of their lungs, heart and other organ systems. In this setting, ultrasound is uniquely capable of providing a safe, reliable and relatively inexpensive means of imaging these vulnerable patients, and the addition of an ultrasound enhancing agent may be essential for evaluating heart function.


ICUS is supporting the ultrasound community and patients worldwide by gathering the latest medical literature and training resources addressing the safe and optimal delivery of ultrasound services during this rapidly evolving global crisis. These resources include protocols for protecting personnel, disinfecting equipment, safely administering ultrasound contrast or enhancing agents, and appropriately imaging the heart, lungs and other organ systems in highly vulnerable patients.


CLICK HERE to learn more. Additional submissions may be sent to info@icus-society.org


The ICUS family extends heartfelt wishes for your safety and health as we come together to defeat this deadly virus.


Global Contrast-Enhanced Ultrasound (CEUS)

Click on any country shaded in orange to see the commercially available agent(s). Zoom to see smaller countries.
 

(Agent(s) commercially available)

 

 

(No agent commercially available at this time)

 

* See package inserts for approved indications. Note that this “Global CEUS” map lists certain ultrasound contrast agents under different product names (i.e., Lumason/SonoVue and Definity/Luminity). ICUS will update this map as additional agents are approved throughout the world.

 

ICUS does not endorse or recommend the use of any ultrasound contrast agent or other medical product. In addition, ICUS does not warrant the accuracy of information provided in package inserts or herein. Medical decisions are the sole responsibility of health care providers and their patients, who are encouraged to carefully evaluate all potential risks and benefits associated with the use of any medical product or procedure including ultrasound contrast agents and (CEUS).


 

Enhanced ultrasound bests CT, MR for diagnosing some liver cancers

Enhanced ultrasound bests CT, MR for diagnosing some liver cancers

September 20, 2020 — Health Imaging Oncology Imaging
By Julie Ritzer Ross
Contrast-enhanced ultrasound (CEUS) helps physicians accurately diagnose some forms of liver cancer more safely and less expensively than computed tomography (CT) and magnetic resonance (MR), according to a report published earlier this month in Hepatoma Research.
CEUS shows “comparable performance with CT and MR for liver mass characterization and prediction of malignancy,” lead author Stephanie Wilson, M.D., head of the Department of Radiology at the University of Calgary, et al., said (read more…)

Vascular Imaging of Pulmonary Disorders

Vascular Imaging of Pulmonary Disorders

Qualitative color Doppler sonography shows varied and partly characteristic findings in the presence of various types of lung consolidations
September 17, 2020 — Imaging Technology News Radiology Imaging
By Robert Bard, M.D. PC, DABR, FASLM
Abstract
COVID-19 is routinely studied using lung ultrasound and quantifying the disease by the “white lung” appearance of multiple B-lines targeting the pulmonary parenchyma. All modern sonographic equipment offers color Doppler features, which have not been fully utilized in the differential diagnosis of inflammatory and malignant lesions. In addition (read more…)

Contrast-Enhanced Ultrasound in Pediatric Imaging

Contrast-Enhanced Ultrasound in Pediatric Imaging

Springer Publishing
Introduction
This book is a comprehensive guide to the rapidly evolving field of contrast-enhanced ultrasound (CEUS) in the child. The uses and interpretation of CEUS are clearly explained with the aid of numerous illustrations. The coverage encompasses both established indications, such as focal liver lesions, abdominal solid organ injury, and vesicoureteral reflux, and a range of newer applications. Extensive information is also provided on microbubble agents and their use in the pediatric age group, as well as on practical aspects (read more…)

Identification of Need for Ultrasound Enhancing Agent Study (the IN-USE study)

Identification of Need for Ultrasound Enhancing Agent Study (the IN-USE study)

September 9, 2020 — Journal of the American Society of Echocardiography (JASE)
Background
Ultrasound enhancing agents (UEAs) are routinely used to improve transthoracic echocardiographic (TTE) image quality, yet anticipation of UEA need is a barrier to their use.
Methods
Structured report data from 171,509 consecutive TTE studies in 97,515 patients who underwent TTE imaging from January 26, 2000, to September 20, 2018, were analyzed. Trends in UEA use and suboptimal image quality were examined. Among outpatients (92,291 TTE examinations, n = 56,479), the data (read more…)

Review of ultrasound contrast agents in current clinical practice with special focus on DEFINITY® in cardiac imaging

Review of ultrasound contrast agents in current clinical practice with special focus on DEFINITY® in cardiac imaging

September 8, 2020 — Future Medicine
Abstract
Echocardiography is the most widely used noninvasive modality to evaluate the structure and function of the cardiac muscle in daily practice. However, up to 15–20% of echocardiograms are considered suboptimal. To enable accurate assessment of cardiac function and wall motion abnormality, the use of ultrasound microbubble contrast has shown substantial benefits in cases of salvaging nondiagnostic studies and enhancing the diagnostic accuracy in daily practice. DEFINITY® is a perflutren based, lipid shelled microbubble contrast agent, (read more…)

Diagnostic Value of Contrast-Enhanced Ultrasound for Differential Diagnosis of Malignant and Benign Soft Tissue Masses: A Meta-Analysis

Diagnostic Value of Contrast-Enhanced Ultrasound for Differential Diagnosis of Malignant and Benign Soft Tissue Masses: A Meta-Analysis

Ultrasound in Medicine and Biology – September 6, 2020
Abstract
This meta-analysis was aimed at investigating the value of using contrast-enhanced ultrasound (CEUS) in the differential diagnosis of benign and malignant soft tissue masses (STMs). Relevant studies published before March 24, 2020 were identified through a comprehensive search of PubMed, Ovid, Cochrane and Web of Science. According to the inclusion criteria, five studies were selected comprising 746 patients. In the differential diagnosis of benign and malignant STMs, the pooled sensitivity and specificity (read more…)

A Survey of CEUS Education in Sonographer Training Programs: The Well-Opacified and Delineated Road Less Travelled, and Ready to be Taken

A Survey of CEUS Education in Sonographer Training Programs: The Well-Opacified and Delineated Road Less Travelled, and Ready to be Taken

September 2, 2020 — Journal of the American Society of Echocardiology (JASE)
Extract
Contrast enhanced ultrasound (CEUS) is a safe, portable, radiation-free imaging tool that produces high resolution, real-time images of the cardiovascular system, tumors, and organ blood vessels. When used during transthoracic echocardiography, CEUS can dramatically improve the detection of functional or structural abnormalities of the left and right ventricles, and enables detection and characterization of cardiac masses. Indeed, for over two decades contrast echocardiogra-phyhas been considered an essential component for (read more…)

Contrast-enhanced ultrasound of focal liver masses

Contrast-enhanced ultrasound of focal liver masses

September 1, 2020 — Hepatoma Research
Abstract
Non-invasive imaging is the current method of choice for the characterization of frequently discovered focal liver disease. Although historically, contrast-enhanced computed tomography (CT) and magnetic resonance (MR) scans have been selected for this purpose, contrast-enhanced ultrasound (CEUS) now offers a less expensive and safer method to acquire the same information. Performed with the intravenous injection of a microbubble contrast agent, CEUS provides some unique advantages that make it a valuable addition to an imaging toolbox. (read more…)

Contrast group asks FDA to pull ‘black box’ warning

Contrast group asks FDA to pull ‘black box’ warning

September 1, 2020 — AuntMinnie.com
By AuntMinnie.com staff writers
A group representing users of ultrasound contrast agents on August 31 asked the U.S. Food and Drug Administration (FDA) to pull its longstanding “black box” warning on the label of contrast agents.
The International Contrast Ultrasound Society (ICUS) filed a citizens petition with the FDA asking for the removal of the warning. The group claims that recently published clinical studies indicate that the warning is outdated and that ultrasound contrast is extremely (read more…)

Ultrasound society urges FDA to eliminate ‘outdated’ contrast label warnings

Ultrasound society urges FDA to eliminate ‘outdated’ contrast label warnings

September 1, 2020 — Health Imaging
By Matt O’Connor
A nonprofit medical society on Monday urged the U.S. Food and Drug Administration to eliminate “black box” warnings on ultrasound contrast agent labels.
The International Contrast Ultrasound Society made that appeal in a Citizens Petition submitted to the FDA. The Chicago-based organization—which represents cardiologists, radiologists and other imaging experts—pointed to clinical evidence supporting the safety and value of such contrasts.
“It is now abundantly clear that UCAs are extremely safe, and that they may save (read more…)