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. 

approved approval safe

Imaging platform that illuminates residual breast cancer in real-time gets 'historic' FDA approval

LumiSystem enables surgeons to intraoperatively illuminate residual cancerous tissue in the breast cavity during lumpectomy surgery.

April 18, 2024
the words "FDA recall" on a board

Boston Scientific recalls premixed embolic agent after two deaths

There have been a total of 11 incidents so far, including seven injuries and two deaths. Boston Scientific said the agent can still be used if operators follow specific instructions during lower GI bleed embolization procedures.  

April 17, 2024
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Imaging agent that targets deadly brain tumors given FDA's Fast Track designation

Fast Track designations are typically granted to drugs that target an unmet medical need. 

April 17, 2024
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SIR releases new guidance on the use of interventional radiology in pediatric trauma care

Interventional procedures play an integral role in managing traumatic pediatric injuries nonoperatively, though specific guidelines for the use of endovascular interventions in this setting have not been fully defined prior to these latest recommendations.

April 15, 2024
artificial intelligence AI heart cardiology

FDA assisting with new imaging 'marketplace' designed to improve AI

The Advanced Research Projects Agency for Health has launched a survey for stakeholders to provide input on the project’s development.

April 1, 2024
The rapid rise of artificial intelligence (AI) has helped cardiologists, radiologists, nurses and other healthcare providers embrace precision medicine in a way that ensures more heart patients are receiving personalized care.

FDA clears AI-enhanced 3D heart models generated from MR and CT images

The inHeart models significantly reduce cardiac ablation surgery times.

March 20, 2024
Breast arterial calcifications (BACs) identified on screening mammograms may help identify women who face a heightened risk of developing cardiovascular disease (CVD), according to a new analysis published in Clinical Imaging.

Incidental breast calcifications on mammograms linked to much higher risk of cardiovascular disease

These findings may say a lot more about a patient's long-term health than clinicians realized. 

March 18, 2024
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FDA votes in support of benefit-risk profile for Lumisight imaging agent

Use of Lumisight in conjunction with the Lumicell fluorescent imaging system was found to be safe and effectively guide breast cancer surgeries.

March 11, 2024

Around the web

"Gen AI can help tackle repetitive tasks and provide insights into massive datasets, saving valuable time," Thomas Kurian, CEO of Google Cloud, said Tuesday. 

SCAI and four other major healthcare organizations signed a joint letter in support of intravascular ultrasound. 

The newly approved AI models are designed to improve the detection of pulmonary embolisms and strokes in patients who undergo CT scans.

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