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. 

Ivenix infusion kits recalled by FDA due to serious manufacturing defect

Lines included in the kits were misassembled and could result in a botched blood transfusion. Due to the risk of serious injury or death, the recall has been designated as Class I.

FDA recalls pediatric breathing kits after eight serious injuries

Endotracheal tubes inside Medline neonatal intubation kits have been deemed too narrow, putting newborn patients at risk for hypoxia. This recall has been given the most serious FDA designation due to the risk of death.

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Bayer seeks FDA approval for gadoquatrane, its latest low-dose GBCA

The investigational agent uses 60% less gadolinium without sacrificing image quality, according to recent clinical trial findings.

Medicare

Senate unveils budget proposal that ditches House’s radiologist Medicare pay hike

Radiology advocates on Monday said they were "deeply disappointed" with the decision while emphasizing it is still early in the process. 

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Radiology Partners scores No Surprises Act wins at 600% of ‘qualifying payment amount’

UPDATED: “These high numbers highlight the disconnect between the two sides as they debate what constitutes a reasonable payment for OON services,” experts write in Health Affairs

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Judge rips Trump administration for terminating DEI-advancing NIH grants: ‘Have we no shame?’

On Monday a district judge in Massachusetts declared the Trump administration’s squashing of billions in NIH grants “void and illegal.” 

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FDA recalls Zyno infusion pumps, citing risk of death

Some infusion systems manufactured by Zyno Medical were released with unapproved software that could cause safety features to malfunction. Use of any device subject to the recall is to cease immediately. 

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Why more doctors should pursue business and leadership training

“Just as medicine has its own language, so does business," two surgeons explained in a new editorial.