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.

BioTech company raises $161M in IPO

The company is pursuing treatments that could target diabetes and obesity in a pill form.

An example of an FDA cleared radiology AI algorithm to automatically take a cardiac CT scan and identify, contour and quantify soft plaque in the coronary arteries. The Cleerly software then generates an automated report with images, measurements and a risk assessment for the patient. This type of quantification is too time consuming and complex for human readers to bother with, but AI assisted reports like this may become a new normal over the next decade. Example from Cleerly Imaging at SCCT 2022.

Legal considerations for artificial intelligence in radiology and cardiology

There are now more than 520 FDA-cleared AI algorithms and the majority are for radiology and cardiology, raising the question of who is liable if the AI gets something wrong.

Scientific misconduct and bias in cardiovascular imaging research among concerns reported in new survey

The data, published in Clinical Imaging, reveal that more than 20% of respondents have witnessed scientific fraud within their department and more than 85% reported the issue of publication bias.

Interoperability among hospitals is improving

Overall, hospital engagement in three domains of interoperability––receiving data, finding data and integrating data––have significantly increased since 2017.

Global Pharma Healthcare recalls eye drops over possible contamination

The drops were linked to 55 reports of adverse events, including eye infections, permanent loss of vision and one death with a bloodstream infection.

FDA grants passage to autonomous, biology-guided radiotherapy

A therapeutic oncology company has been cleared to market a cancer treatment that that turns a tumor’s own biology into a self-signaling target for radiation therapy.

AI program ChatGPT now has a published article in Radiology—is it any good?

The human author reviewing the article wrote about the benefits and inherent risks of utilizing AI in a medical publication setting, concluding that, overall, it could be “a powerful tool” used in the future of medical publishing—when used with caution.

Abbott FlexAbility Sensor Enabled Ablation Catheter FDA

Abbott gains new FDA approval for one catheter, CE mark approval for a second catheter

Both devices were approved for treating significant heart rhythm issues.

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