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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FDA clears AI-powered brain MRI evaluation software

The newly approved system was designed to assist clinicians with the detection of Alzheimer's disease and other forms of dementia.

FDA announces recall of Abbott neurostimulation devices after MRI-related issues lead to 73 injuries

The new recall, which includes more than 155,000 implantable pulse generators, is due to ongoing issues with the devices being unable to exit MRI mode and return to normal use. 

IGAR surgical robot. Image courtesy of Insight Medbotics.

FDA clears new MRI-compatible robot for breast biopsies

The newly cleared device from Insight Medbotics represents a collaboration between robotics experts and surgeons. 

Video of Denise Garris, ASE regulatory consultant and principal of the Korris Group, explaining how reimbursements from insurance andMedicare work to pay or cardiac ultrasound exams. #ASE #ASE360 #ASE23 #ASE2023 #healthcarereimbursment

Understanding reimbursements and coding for echocardiography

"I think everyone would agree that the current fee-for-service model is not working appropriately and there needs to be a fix," regulatory consultant Denise Garris explained in a new interview. 

FDA clears AI tool to boost quality of prenatal ultrasounds

Paris, France-based Sonio also recently raised $14 million in series A financing led by Cross Border Impact Ventures. 

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Appropriate use of imaging proven teachable during medical ed

Radiology education researchers have created an image-intensive online course for third- and fourth-year medical students wishing to learn radiology remotely.

Interventional radiology has a representation problem, according to surveyed medical students

Gaps in mentorship are of particular concern for students who might have otherwise pursued a career path in IR, data show.

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Will PET imaging be covered alongside new Alzheimer's drugs? CMS dodges topic in new coverage decision

The recent CMS coverage determination did not make any mention of beta-amyloid PET imaging that is necessary for both diagnosing Alzheimer’s and monitoring the effectiveness of related treatments.

Around the web

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.

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.

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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