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.

Stereotaxis gains FDA approval for new robotically navigated cardiac ablation catheter
This new-look RF ablation catheter moves through the use of computer-controlled magnets, providing electrophysiologists with improved maneuverability and precision.
FDA approves new stent for deep venous disease
According to Gore, the newly approved device was built with conformability, strength and fracture resistance in mind.
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.
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.
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.

Magic Magnetic Interventional Ablation Catheter

Stereotaxis gains FDA approval for new robotically navigated cardiac ablation catheter

This new-look RF ablation catheter moves through the use of computer-controlled magnets, providing electrophysiologists with improved maneuverability and precision.

FDA approves new stent for deep venous disease

According to Gore, the newly approved device was built with conformability, strength and fracture resistance in mind.

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.

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.

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.

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.

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

2026: Healthcare-specific 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.