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.

Boston Scientific has received U.S. Food and Drug Administration (FDA) approval for its Agent Drug-Coated Balloon (DCB) for the treatment of coronary in-stent restenosis (ISR) in patients with coronary artery disease.

FDA approves Boston Scientific’s new drug-coated balloon for coronary in-stent restenosis

Interventional cardiologists have been anticipating this news for quite some time. The device, the first of its kind, provides an alternative treatment option to repeat PCI or cardiac surgery for patients with coronary ISR.

DOJ collects $1.9B from healthcare in 2023, with imaging provider making 1 of the biggest payouts

Cardiac Imaging Inc. agreed to pay $85 million in October, the largest judgment in the “Laboratory, Pathology, Radiology and Diagnostics" category.

Biosense Webster gained CE mark approval for its Varipulse pulsed field ablation (PFA) system in Europe

Biosense Webster gains CE mark approval for new PFA system

The news represents yet another big regulatory approval for PFA technology in 2024. Could FDA approval be next for Biosense Webster?

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Change Healthcare cyberattack having an ‘alarming’ impact on physician practices, advocates warn HHS

Since the issue arose on Feb. 21, providers in radiology and other specialties have experienced “substantial” billing and cash flow disruptions, MGMA reported Wednesday.

Court upholds decision to strip radiologist of license for performing cosmetic surgeries

Wade Banker, MD, disputes the allegations and is appealing the ruling.

Lawsuit accuses radiology AI vendor MIM Software of patent theft

Progenics Pharmaceuticals Inc. claims MIM stole its patents and used them to help entice GE HealthCare to buy the company in January.

Hologic breast care devices could cause life-threatening complications, FDA warns

UPDATED: BioZorb is FDA cleared for the radiographic marking of soft tissue sites for future procedures such as radiation therapy.

Dozens of Indigenous Canadians file lawsuit against two radiologists over undisclosed study

The plaintiffs claim they were imaged for a liver disease study without giving their consent, or learning of the results.

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