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. 

Cardiologists, radiologists say EPA’s new sterilization proposal could put patients at risk

The primary concern is that sterilization facilities and healthcare providers would not have enough time to adapt to the proposal. Devices impacted would include pacemakers, angioplasty balloons and catheters, just to name a few. 

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FDA approves first cellular therapy to treat type 1 diabetes

The new therapy, made from the pancreatic cells of deceased donors, is designed to help adult type 1 diabetes with severe hypoglycemia go a year or longer without needing to take insulin. 

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Former Johnson & Johnson sales rep indicted for defrauding hospital out of hundreds of thousands of dollars

The sales representative is alleged to have falsely documented his sales numbers on invoices submitted to the hospital’s billing department in addition to interfering with their sterilization processes, according to the DOJ.

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FDA announces recall of more than 250,000 interventional devices due to risk of catheter separation

The FDA has said this is a Class I recall, which means using the devices “may cause serious injuries or death.” A total of 18 injuries have been reported so far. 

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FDA approves Bayer’s imaging agent Ultravist for use in contrast-enhanced mammography

The Germany-based corporation said this is the “only contrast agent approved for this indication” in America. 

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American College of Radiology voices support for MD tapped to lead NIH amid confirmation hearing holdup

“We must not lose momentum," ACR, the Academy for Radiology & Biomedical Imaging Research and more than 100 other organizations wrote to leaders of the U.S. Senate. 

The U.S. Food and Drug Administration (FDA) priority review, the FDA has cleared the Agepha Pharma USA LLC's drug Lodoco (colchicine) as the first anti-inflammatory atheroprotective cardiovascular treatment.

Cardiologists applaud FDA’s approval of colchicine for CVD

"The FDA's approval of colchicine confirms that we are entering a new era of patient care," said one veteran cardiologist familiar with the drug. 

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Physician-owned hospitals charge less for imaging than their counterparts

The finding comes as lobbying groups urge Congress to repeal an ongoing moratorium on doc hospital ownership