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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AI could reduce reliance on gadolinium for contrast-enhanced MRI

New artificial intelligence technology could be used as a complimentary tool alongside low-dose GBCAs to enhance exams without sacrificing image quality.

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Hospital system sues UnitedHealth over ‘denied, delayed’ Medicare Advantage reimbursement

Tennessee-based Ballad Health said it's tried for years to resolve the issues with the insurer but now has 'no choice' but to take legal action, as denied claims are leading to longer hospital stays and higher expenses.

ASE leading push to revise CPT code for interventional echocardiography

The pressure is on for ASE and other societies to create a new CPT code for the use of interventional echocardiography during structural heart procedures.

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FDA confirms Class I recall for Johnson & Johnson devices due to durability concerns

The issue, first reported in September, was linked to five patient injuries. Devices not being actively used should be returned to Johnson & Johnson MedTech for updates.

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FDA announces recall of ultrasound systems impacted by software glitch

The inaccurate measurements could lead to misdiagnoses or improper treatment, a regulatory notice suggests.

Novartis seeks to expand use of prostate therapy Pluvicto, citing positive trial results

An expanded approval could potentially double the number of patients eligible for treatment with the therapy, first approved in 2022.  

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FDA approves oral semaglutide for reducing cardiovascular risks in adults with type 2 diabetes

Rybelsus from Novo Nordisk is officially the first oral GLP-1 drug approved for this indication. The FDA's decision was based on the SOUL trial, which included data from more than 9,000 patients with type 2 diabetes.

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Judge blocks Trump's shutdown layoffs—1,200 HHS workers spared for now

U.S. District Court Judge Susan Illston said the firings appear to be politically motivated and may exceed the authority of the executive branch. She sided against the Trump administration, issuing a temporary restraining order to stop 4,200 federal employees from being fired.