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. 

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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. 

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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.

medical debt

$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.

UnitedHealthcare UHC UnitedHealth

$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. 

CDC considers letting nurse practitioners, physician assistants read X-rays under federal program

The agency's “B Reader Program” trains and certifies physicians to classify chest radiographs of workers participating in federal health surveillance programs. 

artificial intelligence AI infrastructure

Industry Watcher’s Digest

New Year’s Day brought the go-live for California’s new law forbidding the use of AI to deny health insurance claims. 

FDA AI enabled medical devices approval clearance

FDA to hopeful marketers of AI-equipped medical devices: Think beyond your initial approval

Some FDA-approved medical devices age more safely than others. That’s no less true of AI-enabled technologies than of any others. The agency spells out the ramifications in draft guidance issued this week.