Policy & Regulations

This channel includes news coverage of healthcare policy and regulations set by Congress, the states, Centers for Disease Control and Prevention (CDC), the Department of Health and Human Services (HHS), U.S. Food and Drug Administration (FDA), and medical associations and societies. 

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USPSTF stops short of recommending supplemental imaging for women with dense breast tissue

Experts, medical organizations and advocates alike are coming forward saying that the new guidelines “do not go far enough,” particularly when it comes to addressing the screening needs of certain patients. 

Take Care of Maya johns hopkins attorneys seek retrial

Reads completed on 'less sophisticated' monitors have radiology group refuting claims of billing fraud in court

The suit claims the group wrongfully billed CMS for over $6 million in image reads that did not qualify for Medicare reimbursement due to the subpar computer monitors used to view the studies.

Sectra receives FDA approval for use of DICOM in digital pathology

Sectra receives FDA's first clearance for use of DICOM pathology images

The clearance covers the use of Sectra’s digital review application in conjunction with Leica’s Aperio GT 450 DX scanner.

Philips Headquarters

Philips tackling radiology-related manufacturing issues after FDA warning

The Amsterdam-based industry giant has extended its inspection window to ensure that no additional imaging equipment recalls are missed.

Imaging platform that illuminates residual breast cancer in real-time gets 'historic' FDA approval

LumiSystem enables surgeons to intraoperatively illuminate residual cancerous tissue in the breast cavity during lumpectomy surgery.

the words "FDA recall" on a board

Boston Scientific recalls premixed embolic agent after two deaths

There have been a total of 11 incidents so far, including seven injuries and two deaths. Boston Scientific said the agent can still be used if operators follow specific instructions during lower GI bleed embolization procedures.  

Imaging agent that targets deadly brain tumors given FDA's Fast Track designation

Fast Track designations are typically granted to drugs that target an unmet medical need. 

SIR releases new guidance on the use of interventional radiology in pediatric trauma care

Interventional procedures play an integral role in managing traumatic pediatric injuries nonoperatively, though specific guidelines for the use of endovascular interventions in this setting have not been fully defined prior to these latest recommendations.

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Around the web

Cardiovascular Business
A closer look at how FDA's flurpiridaz approval will impact nuclear cardiology

The newly approved PET radiotracer is expected to improve patient care significantly. “We have been able to reach the pinnacle of myocardial perfusion imaging with flurpiridaz," one expert said.

Cardiovascular Business
'This could be a paradigm shift': How PET with newly approved flurpiridaz compares to SPECT

GE HealthCare's flurpiridaz, the PET radiotracer that recently received FDA approval, offers several key benefits over SPECT. Jamshid Maddahi, MD, discussed the details in an exclusive interview. 

Cardiovascular Business
Ultrafast myocardial contrast echocardiography shows early potential to evaluate CAD

Ultrafast MCE could go on to become a go-to treatment option for obstructive coronary artery disease, according to the authors of a new first-in-human clinical study.

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