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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DOD, University of Nebraska to develop drug therapies for radiation exposure

The University of Nebraska–Lincoln was awarded $11 million from the U.S. Department of Defense to develop drug therapies that will treat radiation exposure for the military. If successful, the findings may also be applied to decreasing radiation exposure emitted from medical imaging technologies such as CT or x-rays, according to a recent report by NET News in Nebraska.

FDA releases draft framework for Pre-Cert pilot program

The FDA released draft regulatory framework and complimentary documents detailing its plans to streamline the review of digital health devices, including artificial intelligence (AI) technology, under its Software Precertification (Pre-Cert) initiative.

FDA releases final guidance on Breakthrough Devices Program

The final guidance outlines program policies, features and the process for manufacturers when pursuing the breakthrough designation, according to a recent FDA news release.

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FDA draft guidance addresses radiation rules for diagnostic x-ray manufacturers

When finalized, the draft will supersede the guidance first issued on the subject in 1989 by the FDA, entitled the “Clarification of Radiation Control Regulations for Diagnostic X-ray Equipment."

MITA, patient advocates urge lawmakers to repeal medical device tax by end of 2018

The Right Scan Right Time patient and survivor community network of the Medical Imaging and Technology Alliance (MITA) met with Senators at Capitol Hill last week urging for permanent repeal of the medical device tax, according to a recent MITA news release.

FDA publishes De Novo Classification Proposed Rule to improve medical device review

If finalized, the proposed regulations and requirements of the new rule will “provide structure, clarity and transparency” for the De Novo classification process and include processes and criteria for accepting, granting, declining and withdrawing De Novo requests, according to the FDA.

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Valerie Jackson named president of RSNA

Valerie P. Jackson, MD, was named president of the Radiological Society of North America (RSNA) Board of Directors, Wednesday, Nov. 28, at its annual meeting in Chicago.

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RSNA elects Jeffrey Klein to board of directors at annual meeting

The Radiological Society of North America (RSNA) elected Jeffrey S. Klein, MD, to its board of directors at its annual meeting in Chicago. Klein will serve as the board liaison for publications and communications.

Around the web

Positron, a New York-based nuclear imaging company, will now provide Upbeat Cardiology Solutions with advanced PET/CT systems and services. 

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.