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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FDA announces Class I recall of ventilators after 3 patient injuries

An unexpected nickel coating on the breathing circuits of Percussionaire Phasitron 5 ventilators is being blamed for the recall. The FDA is asking providers to stop using them immediately. 

HeartLung Technologies, a Houston-based artificial intelligence (AI) company, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for new software that assesses chest CT scans for signs of coronary artery disease (CAD) and other potentially fatal heart conditions. The newly cleared offering, AutoChamber, was designed with opportunistic heart evaluations in mind.

FDA clears AI tool that flags signs of heart disease in chest CT scans

The newly cleared offering, AutoChamber, was designed with opportunistic screening in mind. It can evaluate many different kinds of CT images, including those originally gathered to screen patients for lung cancer. 

Why is the US still dependent on foreign medical isotope production?

The U.S currently does not have any large-scale commercial production of the isotope Mo-99 used for nuclear imaging. It is critical to more 40,000 nuclear imaging exams each day, representing about 80% of all diagnostic molecular imaging procedures.  

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Stewardship Health sale to private equity finalized for $245M

The physician group, once part of Steward Health Care, has been rebranded as Revere Medical.

Helene damage to bridge Baxter North Cove facility in North Carolina.

Baxter producing IV solutions ahead of schedule at Asheville-area site

The company said its largest production line at its North Carolina plant is operational, accounting for 25% of total output. The site was damaged by flood waters from Hurricane Helene. 

ransomware cybercrime

Hackers were inside an Iowa hospital’s network for two weeks

St. Anthony Regional Hospital confirmed patient data was taken by cybercriminals, but the August incident is still being investigated.

Bill introduced in Congress would raise physician reimbursement by 1.9%

The Medicare Patient Access and Practice Stabilization Act aims to change the annual Centers for Medicare and Medicaid Services physician fee schedule, which cut reimbursement by 2.8% for 2025. 

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Lawmakers introduce radiologist-endorsed, bipartisan bill to halt Medicare cuts

Greg Murphy, MD, R-N.C., and colleagues are proposing the Medicare Patient Access and Practice Stabilization Act, which would halt a 2.8% reduction to the conversion factor.  

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