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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Philips Zenition 90 Motorized mobile C-arm with flat detector

Philips’s new motorized C-arm earns FDA clearance

The motorized component removes the need for manual positioning adjustments during procedures, improving both accuracy and efficiency.

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Radiologist who tried to cover up multiple procedural mistakes is handed a career-ending judgment

There were two serious incidents in the span of three months that raised concerns among the radiologist's colleagues, according to official documents. 

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New Drug Application for PSMA-PET 'cold kit' could expand access to prostate imaging

If approved, the kit could allow for more flexible production of prostate cancer imaging agents.

the words "FDA recall" on a board

Dozens of injuries trigger FDA recall of over 50,000 implantable tissue marking devices

The Class I recall, which is the most serious recall the FDA issues, comes after numerous adverse events and complications linked to the radiographic markers were reported.  

Profound Medical prostate ablation contouring assistant

Prostate ablation AI 'contouring assistant' lands FDA clearance

The new module is a machine learning-based segmentation tool that further enhances procedural planning.

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FDA adds more than 120 new AI-enabled medical devices focused on radiology to list of approvals

The FDA has cleared over 150 artificial intelligence- or machine learning-enabled medical devices since the beginning of August.

Radiologist who botched multiple cosmetic procedures calls license revocation 'unfair' in appeals case

The physician's attorneys say that he is being "over punished" for his actions.

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. 

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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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