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.

Medtronic's Evolut FX TAVR valve, designed with 3 golden markers that improve alignment

Medtronic receives CE mark approval for Evolut FX TAVR system

The self-expanding valve, already approved by the FDA, was designed with three gold markers to boost implanter efficiency, an updated catheter tip and a more flexible delivery system.

COVID-19 congress coronavirus Washington

American College of Radiology urges Congress to address ‘worsening’ physician shortages

Of the nearly 21,000 radiologists engaged in active patient care, 53% are age 55 or older, the college's EVP told lawmakers.

Impella Heart Pump Abiomed RECOVER IV RCT cardiogenic shock

FDA warns Abiomed about ‘significant violations’ related to its Impella heart pumps

The agency said Abiomed did not seek the necessary approvals for one Impella-related device and was slow to act on certain safety concerns.

Endotronix gains key approval from FDA, shares new heart failure data

The company can now begin the enrollment process for its PROACTIVE-HF 2 clinical trial, which will focus on treating patients with NYHA class II heart failure.

Mobile imaging provider to pay $85M for false claims stemming from alleged referral scheme

The alleged kickback scheme spanned nine years, with Cardiac Imaging Inc. paying physicians "excessive fees" to oversee PET scans, the DOJ said.

Costco sued over sharing health data with Meta

Costco is accused of using the Meta Pixel tracker to share sensitive information about its customers with the social media giant.

Medical societies representing radiology, emergency medicine and anesthesiology blast new NSA guidance

“Our organizations are strongly opposed to this newest guidance, which further broadens the already significant discretion health plans had," RBMA and others wrote Oct. 9.

Inmate, prison guard stuck to MRI machine at unregulated site

The incident happened at a SimonMed location in Arizona after staff failed to remove a waist shackle from the inmate.

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