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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MRI safety concerns prompt FDA to issue recall for series of ventilators

The Class I recall affects the ZOLL 731 Series Ventilator family, including the AEV, EMV+, and Eagle II models.

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.

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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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