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. 

Is RFK Jr. really conducting an ‘assault on vaccines’? And more high-level news notes

The CDC has gone ahead and changed its recommendations for childhood immunizations. The gnashing of teeth has only just begun. 

U.S. FDA Sign

FDA recalls surgical packs due to risk of microbial contamination

Multiple lots of ophthalmic surgery packs manufactured by Alcon will need to be disposed of, due to an incomplete seal that could cause the sterile bandages and syringes inside to be compromised. Because of the serious health risk posed to patients, this recall has been designated Class I. 

the words "FDA recall" on a board

FDA confirms new recall after catheter sheath was left in patient’s body

This is a Class I recall, which means the FDA believes these devices could cause a serious injury or death.

Cybersecurity lock

New York-based radiology group hit by data breach

During the breach, certain files within the group's network were accessed and copied without permission. 

Edwards Lifesciences Sapien M3

FDA approves TMVR system from Edwards Lifesciences for high-risk heart patients

The Sapien M3 transcatheter mitral valve replacement system is implanted using a transseptal approach. The device previously received CE mark approval in 2025.

private equity corporatization business consolidation

New healthcare private equity reporting requirements set to go into effect

HealthExec zooms in on laws passed in Massachusetts, Oregon and California that are set to change how hedge funds interact with patient care organizations.

Cook Medical endovascular grafts recalled due to risk of coating breaking off, entering patient’s bloodstream.

Endovascular grafts recalled due to risk of coating breaking off, entering bloodstream

Customers are urged to examine their inventory, quarantine any unused products and return them to the manufacturer. 

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Healthcare advocacy in 2025: American Society of Echocardiography reviews a busy year

Healthcare policies have rapidly evolved in recent years, and 2025 was no exception. From payment policies to physician shortages, ASE and other medical societies had plenty to fight for throughout the year.