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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Seimens Healthineers’s SOMATOM CT system gains FDA clearance

In an April 18 company release, Siemens Healthineers announced FDA approval for its SOMATOM go.All and SOMATOM go.Top CT systems.

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FDA releases new medical device safety action plan

The FDA released, "Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health," on April 17 in an effort to enhance programs and processes to assure the safety of medical devices.

FDA clears use of Tracer-QC at Massachusetts Gen

The FDA approved the first use of Trace-Ability’s Tracer-QC at Massachusetts General Hospital for testing of an imaging agent used in positron emission tomography (PET)-N-13 ammonia for injection.

FDA clears new version of SOMATOM Force CT system from Siemens Healthineers

On Friday, April 13, the FDA approved the latest version of the SOMATOM Force, a dual source CT system from Siemens Healthineers.

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Could the future of interventional radiology training lie in 3D-printed models?

A new option for training interventional radiologists in noninvasive procedures allows physicians to replicate patients’ blood vessels in a 3D-printed model, researchers announced at the Society of Interventional Radiology’s annual meeting in Los Angeles.

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Bracco files patent infringement complaint against Jubilant for rubidium-82 generators

Bracco Diagnostics has filed a complaint with the U.S. International Trade Commission (ITC) against radiopharmaceutical firm Jubilant DraxImage and two affiliates, citing patent infringement on its rubidium-82 generators.

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ACR helps NIH exceed funding goals for 2018

The American College of Radiology (ACR), along with more than 300 stakeholder organizations that form the Ad Hoc Group for Medical Research, exceeded its 2018 funding goals with the $1.3 trillion federal budget signed March 23 by President Donald Trump.

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ACR CEO Thorwarth cites Anthem policy in letter following Senate price transparency request

American College of Radiology (ACR) CEO William T. Thorwarth Jr., MD, recently penned a letter to Sen. Bill Cassidy, MD, R-Louisiana, outlining how recent policies implemented by Anthem negatively impact patient access to advanced imaging provided in hospital outpatient departments.

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Around the web

Cardiovascular Business
Positron partners with Upbeat Cardiology Solutions to improve cardiac PET/CT access

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

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.