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. 

heart doctors and surgeons working together. top cardiology hospitals in the United States.

Cardiothoracic surgeons unite to improve clinical practice guidelines

Four leading cardiothoracic surgery societies have joined forces in the name of developing clinical practice guidelines that are more thorough and consistent.

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Q&A: Why are cardiovascular devices involved in so many recalls? FDA policies may be to blame

Cardiovascular devices are more likely to be in a Class I recall than any other device type. The FDA's approval process appears to be at least partially responsible, though the agency is working to make some serious changes. We spoke to a researcher who has been tracking these data for years to learn more. 

child in shock from noise trauma

Surprise active shooter drill at children’s psychiatric hospital results in $13M for victims

The Michigan Department of Health and Human Services failed to notify staff and law enforcement that a simulation at the state-run facility was taking place, resulting in chaos. 

DOJ U.S. Department of Justice HQ

CMS contractor takes $1.2M loss after data breach, DOJ lawsuit

Federal Data Solutions allegedly failed to encrypt screenshots of patient data, stored on a server being paid for with Medicare funds.

Boston Scientific has received U.S. Food and Drug Administration (FDA) approval for its Farawave Nav ablation catheter for the treatment of paroxysmal atrial fibrillation (AFib) and FDA clearance for its new Faraview software

Boston Scientific scores 2 key FDA approvals for PFA mapping technology

The two newly approved technologies are used together to help visualize cardiac ablation procedures performed with Boston Scientific’s Farapulse pulsed field ablation system.

Boston Scientific Obsidio instructions updated

4 deaths prompt updated instructions for embolic agent used in IR procedures

The Obsidio Conformable Embolic is routinely used for vascular embolization procedures.

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New Category I CPT codes announced for treating heart failure with implantable Barostim device

Baroreflex activation therapy with the Barostim device from CVRx has received new CPT codes from the American Medical Association. The codes go into effect in January 2026.

FDA announces recall of Boston Scientific's Obsidio Conformable Embolic

Boston Scientific updates instructions for recalled embolic agent linked to multiple deaths

The premixed embolic agent is designed to embolize hypervascular tumors and occlude blood flow in a patient's peripheral blood vessels. It was recalled in April due to safety concerns.