dismiss

Clean Sweep Live Auction on Wed. May 1st. Click to view the full inventory

DOTmed Home MRI Oncology Ultrasound Molecular Imaging X-Ray Cardiology Health IT Business Affairs
News Home Parts & Service Operating Room CT Women's Health Proton Therapy Endoscopy HTMs Pediatrics
SEARCH
Ubicación actual:
>
> This Story


Conexión o Registro to rate this News Story
Forward Printable StoryPrint Comment
advertisement

 

advertisement

 

Ultrasound Homepage

Purchasing insights for cardiac ultrasound Guidance from the market experts at MD Buyline

Trice Imaging connects imaging devices of large chain healthcare provider Aleris Patients and physicians can view images on laptops, cell phones

New ultrasound tech could help detect pediatric congenital heart disease Visualizes structure and blood flow of babies' hearts

Getting to the heart of cardiac ultrasound technology From premium systems to point of care, an expanding market

Echocardiogram should play role in patient selection for transcatheter mitral valve repair, says study New study highlighted at ACC

Emerging applications of contrast-enhanced ultrasound in pediatric imaging Discussing the benefits of an emerging technology

Hitachi unveils new CT and ultrasound solutions at ECR Standard version of SCENARIA VIEW and three new Arietta ultrasound solutions

Probo Medical acquires Trisonics Now offers an extensive ultrasound service division

Handheld ultrasound finds its way into new hands Insights from Rob Walton, global general manager of primary & affordable care, GE Healthcare

With reimbursement at stake, ACR wants ultrasound equipment receipts CMS poised to slash payments by $112 million

A new petition is calling on the FDA
to remove the 'black box' designation
for ultrasound contrast agents

Petition calls for removal of 'black box' designation for ultrasound contrast agents

por John R. Fischer , Staff Reporter
Ultrasound societies across America and worldwide are calling for the FDA to remove its “black box” designation for ultrasound contrast agent labels.

Expressing their reasoning in a Citizen Petition filed by the International Contrast Ultrasound Society (ICUS), the groups argue that scientific research and studies support UCAs as safe diagnostic imaging products and that the black box misrepresents risks, leading providers to refrain from using the agents in situations where they are medically necessary and making patients apprehensive about using them.

Story Continues Below Advertisement

Servicing GE Nuclear Medicine equipment with OEM trained engineers

We offer full service contracts, PM contracts, rapid response, time and material,camera relocation. Nuclear medicine equipment service provider since 1975. Click or call now for more information 800 96 NUMED



“When the black box was put on the ultrasound contrast agent, there wasn’t enough data to understand their safety,” a spokesperson for ICUS told HCB News. “Since that time, there has been a considerable amount of data that’s been produced worldwide, and a significant amount of clinical experience and growth in the field. It all points to a very strong safety profile for ultrasound contrast agents. As a result of that, the black box misrepresents the level of risk and deters use of agents by some physicians.”

An indicator of the highest level of risk associated with products approved by it, the FDA introduced the "black box" for UCAs in 2007. It has since downgraded packaged insert contraindications three times, as well as removed a 30-minute monitoring requirement for patients with pulmonary hypertension or unstable cardiac cardiopulmonary conditions, and approved new indications for use in adults and children, according to the petition.

The societies claim that UCAs reduce the need for unnecessary downstream tests and related costs by improving the reliability of real-time ultrasound scans, as well as speed up diagnosis and access to appropriate therapy, reduce lengths of stay in the hospital and improve patient care, outcomes and experiences.

They also say that safety studies and independent, peer-reviewed journal trials undertaken after 2007 have since validated the safe use of UCAs. In addition, the agents contain no radioactive material or dye, present no known risk of kidney or liver damage, do not require sedation, and can be metabolized and expelled from body within minutes.

“Our collective experience shows that UCAs are exceedingly safe and beneficial, and they can change patient outcomes and improve patient experiences,” said the Society of Radiologists in Ultrasound in a statement, adding that contrast-enhanced ultrasound is often “equivalent to or superior to CT and MRI, yet it is less expensive, more patient-friendly, more widely available, and completely radiation-free.”
  Pages: 1 - 2 >>

Ultrasound Homepage


You Must Be Logged In To Post A Comment

Anuncie
Aumente su conciencia de marca
Subastas + ventas Privadas
Consigue el mejor precio
Comprar Equipo/Piezas
Encuentra El Precio Más Bajo
Noticias diarias
Lee las últimas noticias
Directorio
Examina todos los usuarios DOTmed
Ética en DOTmed
Ver nuestro programa de ética
El oro parte programa del vendedor
Recibir las solicitudes de PH
Programa de distribuidor con servicio gold
Recibe solicitudes
Proveedores de atención de salud
Ver todos los HCP (abreviatura de asistencia médica) Herramientas
Trabajos/Entrenamiento
Encontrar/rellenar un trabajo
Parts Hunter +EasyPay
Obtener presupuestos para piezas
Certificado recientemente
Ver usuarios certificados recientemente
Recientemente clasificado
Ver usuarios certificados recientemente
Central de alquiler
Alquila equipos por menos
Vende equipos/piezas
Obtén más dinero
Mantenga el foro de los técnicos
Buscar ayuda y asesoramiento
Petición sencilla de propuestas
Obtén presupuestos para equipos
Feria comercial virtual
Encuentra servicio para el equipo
El acceso y el uso de este sitio está conforme a los términos y a las condiciones de nuestro AVISO LEGAL & AVISO DE LA AISLAMIENTO
Característica de y propietario DOTmeda .com, inc. Copyright ©2001-2019 DOTmed.com, Inc.
TODOS LOS DERECHOS RESERVADOS