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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Experts publish updated guidance on nuclear imaging for fevers of unknown origin

Fevers of unknown origin account for around 2% of hospitalizations and can present significant diagnostic challenges for providers.

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CMS approves new MRI standards related to remote scanning

Accrediting body IAC said revisions help imaging facilities ensure the safe delivery of MRIs, including when key personnel are located off-site.

pharmaceutical drug approval process

FDA approves acoramidis, BridgeBio’s new ATTR-CM drug

Acoramidis, a selective transthyretin stabilizer being sold under the brand name Attruby, is now the second ATTR-CM medication to gain FDA approval.

medical debt

Report: 44% of adults in the U.S. are uninsured or underinsured

According to an analysis from the Commonwealth Fund, millions of patients are skipping necessary care and struggling to pay mounting medical debt. 

Medtronic has received U.S. Food and Drug Administration (FDA) clearance for its new InPen smartphone app and announced the launch of its new Smart MDI system. Smart MDI was designed to provide real-time insights for users on multiple daily injection (MDI) therapy. It includes the InPen smart insulin pen, the InPen app and Medtronic’s disposable, all-in-one Simplera continuous glucose monitor (CGM), which received U.S. Food and Drug Administration approval back in August.

Medtronic receives key FDA clearance, launches new diabetes system

Medtronic designed its new Smart MDI system to provide real-time insights to users on multiple daily injection therapy.

artificial intelligence AI in healthcare

Industry Watcher’s Digest

An influential industry group, AdvaMed, really likes President-Elect Trump’s choice of Dr. Oz for CMS administrator. 

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Texas AG sues hospital for $10K after off-duty police barred from carrying guns

Texas Attorney General Ken Paxton claims Memorial Hermann Health System violated a state law that authorizes any establishment serving the public to allow police officers to carry firearms, even if they’re dressed in civilian clothing. 

SCAI celebrated William W. O'Neill, MD, and Cindy L. Grines, MD, two veteran interventional cardiologists who played key roles guiding the development of primary percutaneous coronary intervention (PCI) as a treatment for ST-elevated myocardial infarction (STEMI) patients.

Cardiologists reflect on developing primary PCI in face of criticism and pushback

SCAI celebrated cardiologists William W. O'Neill, MD, and Cindy L. Grines, MD, for the important roles they played in the development of primary PCI. “It was challenging,” Grines explained. “We had the pharmaceutical industry that was anti-primary angioplasty and we had a lot of our own colleagues that were anti-primary angioplasty."

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