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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United Imaging's 5T whole body MRI receives FDA clearance

First 5T MRI to offer whole-body imaging scores FDA clearance

Houston, Texas-based United Imaging announced the clearance of its uMR Jupiter 5T MRI system, the first to offer an 8-channel whole-body multi-transmit system. 

breast cancer mammography screening mammogram scheduling

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. 

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Around the web

Cardiovascular Business
Global shortage of nuclear imaging isotopes may be over

The nuclear imaging isotope shortage of molybdenum-99 may be over now that the sidelined reactor is restarting. ASNC's president says PET and new SPECT technologies helped cardiac imaging labs better weather the storm.

Cardiovascular Business
‘A huge win’: CMS significantly increases Medicare payments for cardiac CT

CMS has more than doubled the CCTA payment rate from $175 to $357.13. The move, expected to have a significant impact on the utilization of cardiac CT, received immediate praise from imaging specialists.

Cardiovascular Business
FDA clears AI tool that flags signs of heart disease in chest CT scans

The newly cleared offering, AutoChamber, was designed with opportunistic screening in mind. It can evaluate many different kinds of CT images, including those originally gathered to screen patients for lung cancer. 

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