dismiss

Clean Sweep Live Auction on Thur. March 28th. 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 Mobile Imaging
SEARCH
Posição atual:
>
> This Story


Início de uma sessão ou Registo to rate this News Story
Forward Printable StoryPrint Comment
advertisement

 

advertisement

 

Ultrasound Homepage

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

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

Probo Medical acquires Trisonics Now offers an extensive ultrasound service division

Prestige Medical Imaging partners with Esaote and Glassbeam Expands portfolio to include MR, ultrasound and analytical software

Konica Minolta adds new features to SONIMAGE HSI Ultrasound with software upgrade Enhances point-of-care MSK procedures

Ohio State to treat epilepsy patients with focused ultrasound in world's first clinical trial For when seizures can't be controlled with medication

Dennis Durmis MITA names chair of board of directors

Capitol acquires network of radiology clinics in Australia Offer CT, MR, mammography, ultrasound and OPG services

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

THE (LEADER) IN MEDICAL IMAGING TECHNOLOGY SINCE 1982. SALES-SERVICE-REPAIR

Special-Pricing Available on Medical Displays, Patient Monitors, Recorders, Printers, Media, Ultrasound Machines, and Cameras.This includes Top Brands such as SONY, BARCO, NDS, NEC, LG, EDAN, EIZO, ELO, FSN, PANASONIC, MITSUBISHI, OLYMPUS, & WIDE.



“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 a Sua Perceção da Marca
Leilões + Vendas Privadas
Comece
O mais melhor preço
Comprar Equipamento/Peças
Encontre
O preço o mais baixo
Notícia diária
Leia
A notícia a mais atrasada
Diretório
Browse tudo
DOTmed Usuários
Ética no DOTmed
Veja o nosso
Programa das éticas
O ouro parte o programa do vendedor
Receba PH
Pedidos
Programa do negociante do serviço do ouro
Receba RFP/PS
Pedidos
Fornecedores de Healthcare
Veja tudo
Ferramentas de HCP
Trabalhos/Treinamento
Achado/suficiência
Um trabalho
Parts Hunter +EasyPay
Comece as peças
Citações
Certificado recentemente
Vista recentemente
Usuários certificados
Recentemente Rated
Vista recentemente
Usuários certificados
Central Rental
Equipamento do aluguel
Para menos
Vender Equipamentos/Peças
Comece
A maioria de dinheiro
Preste serviços de manutenção ao Forum dos técnicos
Ajuda do achado
E conselho
Simples RFP
Comece o equipamento
Citações
Mostra de comércio virtual
Serviço do achado
Para o equipamento
O acesso e o uso deste local são sujeitos aos termos e às condições do nosso OBSERVAÇÃO LEGAL & OBSERVAÇÃO DA PRIVACIDADE
Propriedade de e proprietário DOTmeda .com, Inc. Copyright ©2001-2019 DOTmed.com, Inc.
TODOS OS DIREITOS RESERVADOS