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 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.

Bipartisan group of 233 House members call for Medicare reform

In a letter, the undersigned asked Congress to halt cuts to Medicare reimbursement and enact a permanent system to adjust rates to inflation. 

Wartime powers enacted to address nationwide IV fluid shortage

The Biden Administration has invoked parts of the Defense Production Act to address shortages that stem from Hurricane Helene damaging a Baxter production facility in North Carolina. 

HeartFlow Plaque Analysis Example

New Category I CPT code issued for AI-enabled coronary plaque analysis software

The news comes just days after CMS confirmed these technologies would start receiving expanded Medicare coverage in November. HeartFlow and other AI vendors have already shared their excitement over the decision. 

ai in healthcare

AI software that boosts detection of small brain lesions gains FDA clearance

The software is a collaboration between Bracco Diagnostics, a subsidiary of Bracco Imaging, and Subtle Medical, Inc.

fatty liver disease hepatic steatosis

Radiologists issue ‘call to action’ on looming liver disease ‘crisis’

Imaging plays an essential role in addressing hepatic steatosis. Yet, radiologists have had almost zero involvement in shaping medical knowledge about the disease. 

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Radiology societies say MACs’ refusal to cover imaging guidance for key procedure poses safety risk

ACR, the Society of Interventional Radiology and others recently submitted a letter to 5 of the 7 contractors, expressing concern about trigger-point injections. 

doctors nurses ai in healthcare fda oversight

How the FDA sees its role vis-à-vis AI in healthcare

The U.S. Food and Drug Administration has its hands full making sure medical AI products are safe, efficacious and trustworthy before they hit the market. The rise of ever-more-innovative iterations of the technology—not least generative AI—is only adding to the burden.