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.

White House to end civil service protections for 50,000 federal workers
President Donald Trump's administration said an executive order to implement Schedule F, to make it easier to fire federal works that don't align with its agenda of "draining the swamp," is forthcoming.
Proposed HHS budget would close NINR, cut nursing programs
The American Nurses Association is warning that eliminating support for the training and research offered by the National Institute of Nursing Research could be devastating to the public, as many programs support specialties such as maternal and mental health.
FDA warns that certain coronary imaging catheters are being removed from market over safety concerns
A catheter sheath detached during use and was left in the patient’s body. It was successfully removed, but the FDA said it is now evaluating the potential risk to others going forward. There is no official recall at this time.
FDA clears new cold cathode tomosynthesis system
Cold cathode tubes make for smaller systems that are lighter in weight and require less energy to operate, also resulting in decreased costs.
Arkansas the 30th state to pass legislation bolstering coverage for breast imaging
Gov. Sarah Huckabee Sanders signed Senate Bill 123 into law on April 14 following its passage by the state legislature, weeks after Virginia passed a similar bill.

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New tau imaging agent granted FDA's Fast Track designation

Life Molecular Imaging's new agent has demonstrated promising brain uptake, fast wash-out in non-target regions and excellent reproducibility.

Renata Medical, a California-based healthcare technology company, has gained U.S. Food and Drug Administration (FDA) approval for a new stent specifically designed for pediatric patients with congenital heart defects. The Minima Growth Stent was built to treat newborns, infants and young children, and then it continues to expand as the patient ages

FDA approves new expanding stent for young children

The new interventional device from Renata Medical is designed to expand as young patients age, providing long-term relief.

Insulet Corporation, a Massachusetts-based medical device company focused on diabetes technology, announced that its Omnipod 5 Automated Insulin Delivery System is now cleared by the U.S. Food and Drug Administration (FDA) to manage type 2 diabetes (T2D).

FDA clears first automated insulin pump for type 2 diabetes

Insulet's Omnipod 5 Automated Insulin Delivery System was already cleared to help patients manage type 1 diabetes.

Cardiology groups share new AUC for cardiovascular imaging prior to noncardiac surgery

The new AUC document was designed to help care teams know when and how to perform imaging-based cardiovascular evaluations on patients undergoing nonemergent, noncardiac surgery.

Boston Scientific TAVR ACURATE Prime Aortic Valve System

Boston Scientific’s new TAVR valve gains CE mark approval

The self-expanding Acurate Prime Aortic Valve System was designed with improved valve positioning in mind. According to Boston Scientific, it it will be available in more sizes than the company's previous TAVR device to ensure it can treat as many heart patients as possible.

Political intervention necessary to preserve ‘vanishing’ small independent practices, experts charge

Such organizations often lack the required IT infrastructure, population health expertise and relationships to navigate value-based care models.

Outpatient radiology providers missing the mark when communicating costs to patients

About 17% of healthcare consumers were aware of one health system's estimator tool, but 0% had used it, according to new survey data.

Medicare coverage for weight loss drug semaglutide could cost up to $145B per year

Medications that target obesity are not typically covered by Medicare. When the FDA approved semaglutide as a way to treat certain cardiovascular risks, however, CMS said Medicare coverage was on the table.

Policy & Regulations

White House to end civil service protections for 50,000 federal workers

Proposed HHS budget would close NINR, cut nursing programs

FDA warns that certain coronary imaging catheters are being removed from market over safety concerns

FDA clears new cold cathode tomosynthesis system

Arkansas the 30th state to pass legislation bolstering coverage for breast imaging