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. 

Cardinal Health recalls some Monoject syringes

The company’s “Cardinal Health”-branded Monoject syringes, released in June 2023, were manufactured by a different contractor and differed slightly in dimensions from the “Covidien”-branded syringes, which could put patients at risk.

FDA approves first transcatheter tricuspid valve replacement device, the EVOQUE system from Edwards Lifesciences

Edwards makes history, receives FDA approval for transcatheter tricuspid valve replacement device

The approval, based on positive results from the TRISCEND II trial, represents a significant milestone for the treatment of severe tricuspid regurgitation. 

Money court lawsuit judge ruling scales of justice

Hospital pays $801,000 to settle allegations radiology practices billed for ‘shoddy’ imaging services

Physicians allegedly submitted false claims to Medicare and Medicaid for scans they either never reviewed or failed to assess in a timely fashion. 

Philips X11-4t Mini 3D TEE transducer

FDA clears mini transducer capable of creating 3D ultrasound images

The X11-4t Mini from Philips Healthcare is 35% smaller than traditional models.

CT-first strategy the most effective path forward when evaluating stable chest pain

Heart teams have several options when patients present with stable chest pain and require further testing. According to a brand new analysis of nearly 800 patients, CCTA may be the best place to start. 

Melissa Chen, MD, Clinical Neuroradiologist, Associate Professor, University of Texas MD Anderson Cancer Center, said challenges ton radiology include the limitations of the relative value units (RVUs) used to pay radiologists, the need for balancing workloads despite disincentives to reading some studies, and the need to find new workflow efficiencies with AI to offset the radiologist shortage. #RSNA

Radiology at tipping point with limitations of RVUs and the growing shortage of radiologists

Melissa Chen, MD, MD Anderson Cancer Center, outlines some of the challenges practices are facing and possible solutions.

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FDA announces Class I recall of more than 250,000 chest drains over safety concerns

According to the FDA, using these devices without following manufacturer recommendations could lead to “serious injuries or death." 

Farapulse Boston Scientific Pulsed Field Ablation PFA fda approval

FDA approves Boston Scientific’s pulsed field ablation system for AFib

The FDA’s final decision was based largely on positive results from the ADVENT clinical trial, which compared treatment with the Farapulse PFA System to the current standard of care.