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. 

GE Healthcare recall TruSignal SpO2 sensors

GE Healthcare recalls certain SpO2 sensors due to risk of serious errors during defibrillation

There is a risk of the devices sending a reduced amount of energy to the heart during defibrillation. More than 7,000 devices are being recalled due to this issue.

the words "FDA recall" on a board

FDA announces recall of nearly 8,000 Impella blood pumps due to risk of injury or death in TAVR patients

There have been 30 complaints so far about this issue, including 26 injuries and four deaths.

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Abbott recalls delivery sheath for LAA occluder device after 16 injuries

The FDA has categorized this as a Class I recall, which means using the devices “may cause serious injuries or death.”

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American College of Radiology opposes focus of US House bill aimed at increasing imaging price transparency

Rep. Mike Carey introduced the Imaging Services Price Transparency Act July 25, hoping to better inform patients about services provided by the specialty. 

Cigna

Cigna violated the law by denying claims for imaging and other services in bulk, lawsuit alleges

Plaintiff attorneys are asking for damages in excess of $5 million, not including interest and other costs, and seeking class-action status.

liver cancer

Incorrect CT protocol leads to radiologist overlooking liver cancer, patient’s untimely death

The physician had assigned the standard, four-phase protocol for liver imaging, but the radiographer instead performed a single, portal-venous phase only.

Nanox raises $30M; ViewRay begins pulling stock from Nasdaq, plus more radiology vendor news

Also, MITA urges states to fix breast screening coverage gap, Philips announces Q2 earnings results, and Aidoc inks partnerships with two large health systems. 

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New U.S. guidelines on chronic coronary disease rethink use of beta-blockers, other medications

The updated recommendations from the American College of Cardiology and American Heart Association cover a variety of topics, including patient communication, follow-up imaging, nutritional supplements and more.