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.

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.
AI newswatch: Lifecyle AI oversight, data matters, AI vs. animals, more
AI may finally end the paper chase caused by prior authorization. Or it may worsen it.
Leaked HHS budget reveals 30% cuts, elimination of many core services
A proposal for the massive restructuring of the Department of Health and Human Services ends funding to programs associated with chronic disease management, lead safety, and Head Start. However, HHS is adding a new department to focus on understanding the cause of long-term illness.

Reimbursement update: What hospitals need to know about new Medicare payments for cardiac CT

CMS finalized a significant policy change when it increased the Medicare payments hospitals receive for performing CCTA exams. What, exactly, does the update mean for cardiologists, billing specialists and other hospital employees?

Industry Watcher’s Digest

Is AI adoption a marathon or a sprint?

Dental chain involved in ransomware coverup fined $350K

A regional chain of clinics that lied through its teeth about a data breach has agreed to pay a $350,000 settlement to resolve multiple allegations it violated HIPAA.

Johnson & Johnson pauses use of FDA-approved PFA system to investigate patient complications

Johnson & Johnson MedTech's Varipulse PFA system has been linked to multiple reports of "neurovascular events" in patients. The company hopes to share more information in the days ahead.

Experts update AUC for amyloid, tau PET imaging for first time in more than a decade

The new appropriate use criteria define 17 specific clinical scenarios, guiding providers on situations when amyloid or tau imaging are and are not appropriate.

$49B in medical debt to be erased from credit reports

A new final rule from the Consumer Financial Protection Bureau bans reporting agencies from including medical debts on credit reports or factoring them into credit scores.

$3.3B merger of UnitedHealth and Amedisys delayed by DOJ lawsuit

The new deadline for the deal to be finalized is Dec. 31, 2025. However, the ultimate fate of UnitedHealth's acquisition of Amedisys will be decided in a federal court.

Alleviant Medical, a Texas-based medical device company, has received the FDA’s breakthrough device designation and an investigational device exemption (IDE) for its new atrial shunt that treats heart failure without leaving a permanent implant in the body.

FDA sees value in no-implant heart failure device

The new atrial shunt from Alleviant Medical was designed to treat heart failure without leaving a permanent implant behind. The FDA granted the technology its breakthrough device designation and approved additional research.

Policy & Regulations

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

AI newswatch: Lifecyle AI oversight, data matters, AI vs. animals, more

Leaked HHS budget reveals 30% cuts, elimination of many core services